The Medical Director will collaborate across Medical Affairs, Clinical Development, Commercial, HEOR, Medical Excellence, Field Medical, Medical Information, Scientific Communications, and Publications to ensure alignment, generate impactful scientific evidence, and strengthen external partnerships within the respiratory community.

Key Responsibilities

• Develop and lead the global Medical Affairs strategy for the respiratory indication, ensuring alignment with overall corporate objectives.
• Translate strategic priorities into comprehensive Medical Affairs plans that support key development and launch milestones.
• Provide medical leadership and strategic input to cross-functional teams including Clinical Development, Clinical Operations, HEOR, Commercial, and other key stakeholders.
• Build and maintain strong relationships with external experts, key opinion leaders (KOLs), and the broader respiratory medical community.
• Lead the medical data generation strategy by identifying evidence gaps and developing integrated plans to support scientific and clinical objectives.
• Review scientific publications and develop medical backgrounders, FAQs, standard response documents, and internal training materials.
• Develop and execute a comprehensive thought leader engagement strategy.
• Partner with Medical Strategy, Regional teams, and Finance to develop and manage annual Medical Affairs budgets.
• Foster strong collaboration across Global Medical Affairs, Regional Medical teams, Commercial, Clinical Development, and other functional groups to ensure a unified approach.
• Identify opportunities to incorporate innovative ideas, best practices, and operational improvements into Medical Affairs strategies and activities.
• Ensure all Medical Affairs activities are conducted in compliance with company policies and applicable regulations.

Qualifications

• Previous Medical Affairs experience in pulmonology/respiratory medicine is required.
• Strong understanding of Medical Affairs strategy, planning, and execution, with launch experience preferred.
• Demonstrated success developing innovative Medical Affairs strategies and programs.
• Proven ability to represent Medical Affairs as a strategic leader on cross-functional teams.
• Experience working effectively within a complex global matrix organization.
• Previous leadership experience with the ability to lead through influence across cross-functional teams.
• Global experience, or experience working across multiple regions including the United States, is preferred.
• Strong collaboration and stakeholder management skills across multiple functions.
• Proven track record of driving operational excellence, improving processes, and establishing planning standards.
• Strategic thinker with the ability to connect scientific, clinical, and commercial priorities.
• Demonstrated success leading organizational change and driving continuous improvement.
• Excellent written and verbal communication skills.
• Strong problem-solving abilities with a creative, solutions-oriented mindset.
• Exceptional organizational skills and attention to detail.
• Willingness to travel domestically and internationally as needed (up to 25% travel).

 Education

• MD degree minimum 6 years medical affairs experience

The ideal candidate has hands-on experience with RNA sequencing data, strong computational biology expertise, and enjoys collaborating closely with experimental scientists to generate biological insights that advance therapeutic discovery.

• Process, analyze, visualize, and interpret NGS datasets, including bulk RNA-seq, single-cell RNA-seq (scRNA-seq), and long-read RNA sequencing data.
• Perform bioinformatics analyses including quality control, sequence alignment, quantification, differential expression, isoform characterization, splicing analysis, and biological interpretation.
• Collaborate with cross-functional teams of experimental scientists, computational biologists, and research leaders to support target discovery and validation efforts.
• Translate computational findings into meaningful biological insights that inform research decisions.
• Evaluate and implement new bioinformatics tools, analytical methods, and emerging technologies relevant to transcriptomics and functional genomics.
• Develop scripts, workflows, and analytical pipelines to support reproducible and scalable data analysis.
• Contribute to study design, analytical strategy, and interpretation of research findings.
• Present results and communicate complex analyses clearly to technical and non-technical stakeholders.
• Deliver high-quality work while managing multiple priorities in a collaborative research environment.

• Education & Experience
• MS or PhD in Bioinformatics, Computational Biology, Systems Biology, Genomics, or a related scientific discipline.
• Relevant industry, academic, or postdoctoral research experience in computational biology or bioinformatics.

• Hands-on experience analyzing NGS datasets, particularly:
• Bulk RNA-seq
• Single-cell RNA-seq (scRNA-seq)
• Long-read RNA sequencing using Nanopore (required)
• Experience with PacBio sequencing is a plus.
• Strong understanding of transcriptomics, differential expression analysis, isoform discovery, and RNA splicing analysis.
• Proficiency in Python and/or R.
• Experience working in Linux environments and high-performance computing (HPC) or cloud platforms such as AWS.
• Familiarity with genome annotation resources, biological pathway databases, and systems biology concepts.
• Commitment to reproducible research, documentation, and version control best practices.

• Experience with additional functional genomics data such as ATAC-seq, ChIP-seq, or PRO-seq.
• Drug discovery or biotechnology industry experience.
• Experience collaborating with laboratory scientists in a multidisciplinary research environment.

What We're Looking For

We're seeking someone who is curious, collaborative, and scientifically driven, with excellent communication skills and the ability to work closely with both computational and experimental teams. This individual should be comfortable presenting previous research, explaining analytical approaches, and contributing to a fast-paced drug discovery environment.

As the medical lead for assigned programs, you will provide expert oversight of medical monitoring, clinical strategy, data interpretation, regulatory interactions, and scientific communications. Working collaboratively across Research, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Commercial, and other key stakeholders, you will play a critical role in advancing innovative therapies for patients with neurologic diseases.

Key Responsibilities

• Lead the strategic planning, design, and execution of global clinical development programs across all phases of development (Phase I–III), ensuring the successful delivery of high-quality clinical studies.
• Serve as the therapeutic area lead for the Neurology Gene Therapy Clinical Development team, partnering closely with leaders across Clinical Operations, Toxicology, Regulatory Affairs, Commercial, Pharmacovigilance, Clinical Quality, and Biostatistics.
• Provide medical oversight and monitoring for clinical trials, ensuring patient safety, protocol compliance, data integrity, and overall study quality.
• Lead clinical operational strategy related to site selection, enrollment, feasibility assessments, and study execution, serving as the primary medical escalation point for issues that may impact study quality or timelines.
• Collaborate with Clinical Operations on medical monitoring, coding, safety review, and data cleaning activities.
• Interpret clinical trial data and ensure the scientific accuracy and medical integrity of clinical study reports, presentations, and communications.
• Author or oversee the preparation of clinical sections for regulatory submissions, including INDs, NDAs, BLAs, briefing books, and other regulatory documents.
• Represent the company during interactions with regulatory agencies, including FDA meetings, Advisory Committee presentations, and other health authority engagements.
• Develop or oversee safety management documents, including Data Monitoring Committee (DMC) charters, safety management plans, investigator communications, and other study-specific documents.
• Prepare or review Serious Adverse Event (SAE) reports and Investigator Alert Letters in collaboration with Clinical Operations, as needed.
• Build and maintain strong relationships with CROs, investigators, clinical consultants, key opinion leaders (KOLs), investigational sites, and other external partners supporting clinical development.
• Analyze, interpret, and communicate clinical data through presentations, publications, scientific meetings, and advisory boards.
• Organize and lead Scientific Advisory Board meetings and Data Monitoring Committee meetings.
• Maintain current expertise in neurology, gene therapy, and emerging scientific advances through ongoing literature review and participation in scientific and medical conferences.
• Develop and manage clinical development budgets while providing regular updates on program progress, timelines, and key risks.
• Serve as an active member of the Gene Therapy Leadership Team, contributing to the strategic direction of the business and identifying future opportunities and potential challenges.
• Support business development initiatives, product evaluations, licensing opportunities, and due diligence activities.
• Provide medical and clinical expertise to internal stakeholders, including Research & Development, Commercial, Marketing, Manufacturing, Market Access, Patient Services, Regulatory Affairs, and Legal, as well as external stakeholders such as healthcare professionals, advocacy groups, and data monitoring committees.
• Coach, mentor, and develop direct reports while fostering a collaborative, high-performing clinical development organization.

Qualifications

• MD (or foreign equivalent) with clinical training and experience in Neurology required.
• PhD in a related scientific discipline preferred.
• Minimum of 10 years of clinical development experience within the pharmaceutical or biotechnology industry, including global clinical programs across Phases I–III.
• Minimum of 5 years of leadership experience managing clinical development teams.
• Clinical residency training in Neurology required.
• Pediatric neurology experience preferred.
• Gene therapy experience preferred.
• Demonstrated expertise in medical monitoring, clinical trial design, regulatory strategy, and interpretation of clinical data.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and global clinical development requirements.
• Proven ability to lead cross-functional teams, influence executive stakeholders, and successfully manage complex clinical development programs.
• Excellent scientific communication, presentation, and leadership skills.
• Willingness to travel domestically and internationally up to 20%.

We are seeking an experienced Senior Clinical Programmer to support clinical development programs by delivering high-quality programming solutions for medical monitoring, data management, and statistical programming activities. The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to develop efficient, compliant, and scalable programming solutions that support ongoing clinical trials.

Key Responsibilities

• Provide programming support for medical monitoring, data management, and statistical programming activities across clinical studies.
• Develop specifications for SDTM dataset creation in accordance with CDISC SDTM Implementation Guide (SDTM IG).
• Program, validate, and maintain CDISC-compliant SDTM datasets.
• Create and maintain annotated CRFs (aCRFs) aligned with SDTM specifications.
• Generate outputs and listings to support medical monitoring, data review, statistical endpoint monitoring, and data management activities.
• Develop, enhance, and maintain SAS macros, R functions, and other reusable programming utilities.
• Design, develop, test, and implement programming solutions to address complex business and study requirements.
• Ensure programming deliverables meet quality standards, timelines, and regulatory expectations.
• Collaborate effectively with cross-functional teams including Biostatistics, Data Management, Clinical Operations, and Medical Monitoring.
• Manage multiple projects simultaneously while delivering high-quality work within established timelines.

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline (or equivalent experience).
• Experience programming in the pharmaceutical, biotechnology, or related regulated industry preferred.
• Advanced programming proficiency in SAS, R, and SQL.
• Strong working knowledge of CDISC standards, including SDTM and annotated CRFs.
• Experience with JReview is highly preferred.
• Experience with Shiny, Pharmaverse, and R Markdown is preferred.
• Familiarity with programming languages such as Python, VBA, or C++ is a plus.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Strong organizational skills with the ability to prioritize multiple assignments and meet deadlines.

Preferred Experience

• Experience supporting medical review or clinical data review activities.
• Experience developing reusable programming utilities and automation tools.
• Familiarity with regulatory submission standards and clinical trial data workflows.
• Experience working in a fast-paced clinical development environment.

Our client is a global organization focused on advancing novel therapies for patients with rare diseases, with a clinical pipeline spanning multiple stages of development and therapeutic areas including immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Bringing a collaborative, project-driven structure, the organization is building a forward-looking team dedicated to delivering treatments that make a meaningful impact worldwide. Utilizing three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy, the company continually refines ways in which products can address unmet medical needs and help patients lead full lives.

Currently they are seeking a Principal Biostatistician to provide statistical leadership for clinical development programs. In this role, you will lead components of statistical contribution to clinical development programs, implement statistical strategies for clinical trials and regulatory submissions within the program and will be accountable for statistical deliverables. It’s a fantastic opportunity to become a part of a stable and growing group with a focus on innovation. 

Responsibilities:

• Provide input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
• Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation
• Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.
• Support Biostatistics interactions with regulatory authorities (e.g. FDA, EMA, PMDA)
• Be responsible for interpreting analysis results and ensuring reporting accuracy
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
• Be accountable for the TFL/CDISC package for study report and regulatory submission
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations

Qualifications:

• PhD or MS in Biostatistics, Statistics
• PhD 4+/ MS 6+ years or relevant work experience in the pharmaceutical industry and/or CRO
• Experience either managing a CRO, or having worked in a CRO
• Experience providing statistical leadership at a study level
• Demonstrated statistical contribution in facilitating and optimizing clinical development

Our client is a clinical-stage biotechnology company focused on developing innovative therapies for patients with serious central nervous system (CNS) disorders. Their mission is to advance transformative treatments that address significant unmet medical needs and improve the lives of patients and their families. As they continue to progress our clinical programs, they are seeking a strategic and hands-on Senior Director, Biostatistics to join their growing team.

Position Summary
The Senior Director, Biostatistics will provide statistical leadership across the clinical development programs and play a critical role in advancing our assets through key development and regulatory milestones. Reporting to senior clinical development leadership, this individual will serve as the lead statistician for clinical studies, providing expertise in trial design, statistical methodology, analysis planning, data interpretation, and regulatory submissions.

This role is ideal for an experienced biostatistics leader who thrives in a fast-paced biotech environment, enjoys working cross-functionally, and is comfortable rolling up their sleeves to support both strategic and operational activities. The successful candidate will have extensive experience supporting regulatory submissions and managing external CRO partners while contributing to overall development strategy.

Key Responsibilities

• Serve as the statistical lead across clinical development programs, providing strategic and technical leadership from study design through regulatory submission.
• Lead the development and review of study protocols, statistical analysis plans (SAPs), randomization specifications, TLF shells, clinical study reports, and regulatory submission documents.
• Provide statistical expertise for Phase 1, Phase 2, and Phase 3 clinical studies.
• Collaborate closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and Pharmacovigilance teams.
• Oversee and manage CROs and external statistical programming vendors to ensure high-quality deliverables, timeline adherence, and regulatory compliance.
• Support interactions with regulatory agencies, including preparation for FDA meetings and responses to health authority questions.
• Guide endpoint selection, sample size calculations, estimand strategies, interim analyses, and overall statistical methodology.
• Review and interpret clinical study results and communicate findings to cross-functional teams and executive leadership.
• Ensure compliance with CDISC standards, ICH guidelines, and regulatory expectations.
• Contribute to clinical development plans, target product profiles, and overall program strategy.
• Support due diligence activities, investor communications, and corporate presentations as needed.
• Help establish and refine biostatistical processes and standards appropriate for a growing biotechnology company.

Qualifications
Required

• PhD in Statistics or Biostatistics.
• Minimum of 10 years of biostatistics experience within the pharmaceutical, biotechnology, or CRO industry.
• Significant experience serving as lead statistician for clinical development programs.
• Demonstrated success supporting NDA, BLA, and/or other major regulatory submissions.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Experience overseeing CROs and external statistical programming resources.
• Knowledge of CDISC standards, including SDTM and ADaM.
• Experience supporting Phase 2 and Phase 3 clinical trials.
• Strong communication, leadership, and influencing skills.
• Ability to work effectively in a lean, fast-moving biotech environment where flexibility and hands-on involvement are essential.

Preferred

• Prior experience in CNS, psychiatry, neurology, neurodegenerative diseases, or other neuroscience therapeutic areas.
• Experience supporting FDA meetings and regulatory interactions.
• Familiarity with adaptive designs, Bayesian methodologies, or innovative clinical trial approaches.
• Previous people leadership and mentoring experience.
• Experience working in small or emerging biotechnology companies.

Senior Director, Quantitative Pharmacology

Our client is seeking a director/senior director to head the Quantitative Pharmacology group within its Translational Medicine group in Princeton, NJ. The incumbent will report into the Vice President of Preclinical Development and Translational Medicine. The Quantitative Pharmacology group is responsible for the oversight over drug development aspects related to clinical pharmacology and pharmacometrics of clinical development candidates, working in close collaboration with nonclinical and clinical functional areas. This team works with all therapeutic areas within their Development Division. They are seeking a highly qualified individual to lead the group. Candidates must have a strong background in quantitative drug development and a desire to work collaboratively across different functional areas, as well as with external vendors and partners.

Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues across the Development Division while developing and expanding your career.

Primary Responsibilities:

• Key member of a product development team, contributing to the advancement of novel chemical entities bringing a quantitative perspective into strategic development to support continued investment
• Provide insight and leadership on pharmacokinetic aspects of clinical trials and programs and its application in development strategy
• Drive the implementation of pharmacometric principles and practices
• Development and execution of model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulations, and quantitative systems pharmacology (QSP) modeling
• Provide pharmacometric support for programs through the worldwide marketing application filing including supportive registration documents and presentations
• Provide clear, timely communication and interpretation of study results to functional area experts and governance/senior management
• Contribute to assessment of internal and external opportunities
• Interface broadly with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research
• Mentoring and/or supervision of junior staff to perform above duties and support career development

Qualifications:

• 5+ years of postdoctoral experience in quantitative pharmacology/pharmacometrics in the biotech and/or pharmaceutical industry
• Prior experience in the development and application of quantitative methods in drug development
• Strong background in population PK modeling, exposure response modeling and analysis, and developing statistical and mechanistic models for drug development
• Proven track record in clinical research and background in biomedical research
• Demonstrated record of scientific scholarship and achievement, willingness to work collaboratively across different therapeutic areas.
• Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential

Education:

• PhD in a quantitative science (e.g., statistics, mathematics, engineering, physics, computer science)

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

Job Overview

We are seeking a highly skilled and motivated Biostatistician to lead our biometrics function across multiple studies in one of the late-phase programs for cardiovascular drug development. As the AD Biostatistician, you will be the study lead, representing biometrics in cross functional team meetings. You will be responsible for discussing and shaping the clinical development plan, study design, endpoint selection, statistical analysis plan, and regulatory submission and publication strategy to support pursuant of precision medicine. This role involves overseeing CROs and collaborating with cross-functional teams to deliver high-quality analysis outputs and interpret results.

Essential Duties And Responsibilities

• Collaborate with clinical, regulatory, medical affairs, and other teams to ensure cohesive and integrated project strategies.
• Contribute to clinical protocol development and study reports, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.
• Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings.
• Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
• Provide statistical input to data monitoring committee (DMC) charters.
• Oversee the CROs or internal teams to deliver high-quality and timely analysis outputs and interpret the results.
• Manage statistical activities in support of NDA/MAA or other regulatory submissions.
• Address statistical questions/comments from FDA and other regulatory agencies.
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.
• Contribute or lead standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.
• Provide guidance and oversight to ensure compliance with regulatory standards and best practices.
• Mentor junior statisticians.

Qualifications And Preferred Skills

• PhD in Statistics, Biostatistics, or a related scientific field with 7+ years of experience, or MS with 10+ years of experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
• Expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
• Knowledgeable of machine learning approaches for classification and predictive modeling.
• Excellent communication and presentation skills, with the ability to convey complex statistical concepts to non-statisticians.
• Strong knowledge and hands-on experience of statistical software (SAS, R or Python) and proficiency in implementation of advanced analytical methods especially for data visualization.
• Experience in managing CROs and collaborating with cross-functional teams.
• Experience with NDAs, and MAA’s is highly desired.
• Experience with cardiovascular drug development and digital health data or real-world data is preferred.
• Demonstrated ability to work independently and as part of a team in a fast-paced, dynamic environment.

• Independently update, revise, and finalize regulatory documents, including protocol and IB
• Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2–5) across the submission lifecycle (responses, amendments, briefing packages)
• Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents
• Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards
• Support intermittent workload demands (~10–15 hours/week during active project periods)

• Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions
• Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages)
• Ability to work independently with minimal oversight in a fast-paced, cross-functional environment
• Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards
• Proven collaboration experience with regulatory, clinical, and medical writing teams

We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages.

Key Responsibilities

• Lead statistical programming activities across global studies
• Serve as primary programming lead in collaboration with Biostatistics
• Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards
• Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions
• Validate program outputs and ensure accuracy, quality, and regulatory compliance
• Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively
• Manage timelines, delivery packages, and milestone commitments
  Contribute to continuous improvement of programming processes and standards

Core Requirements

• Strong expertise in CDISC standards, including ADaM and SDTM
• Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables
• Working experience in LSAF environment
• Experience validating CRO programming deliverables
• Ability to operate with increased performance accountability and ownership
• Strong CRO-facing communication and collaboration skills
• Proven ability to manage multiple global studies simultaneously

Additional Requirements 

• Practical experience with multiple imputation (MI), particularly under Missing at Random (MAR) assumptions
• Familiarity with the estimands framework (ICH E9 R1) and managing intercurrent events (ICEs) within ADaM domains using various strategies

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field
• 5+ years of SAS programming experience within pharmaceutical/biotech
• Strong understanding of statistical methods used in clinical trial analysis
• Knowledge of Good Programming Practices and GCP
• Preferred: Experience with R programming

The Senior Real-World Analyst (RWA) will be responsible for conducting analyses for Real-World Evidence (RWE) studies utilizing administrative claims, electronic medical records (EMR), and registry data. The successful candidate will possess a deep understanding about the use of Real-World Data (RWD), exceptional programming and analytical skills and a proven track record in delivering high-quality RWE analytic projects. The candidate will also ensure the timeliness and delivery of scientifically valid research.

Essential Functions

• Effectively designs and codes R and SQL programs for assigned project(s), consistently meeting objectives of the project.
• Clean and validate RWD for consistency and reliability
• Implement programming as specified from RWE protocol using a variety of RWD from multiple sources, including Optum and Flatiron
• Leverage advanced statistical and epidemiological methodologies to deliver robust and reliable analyses
• Create or review and approve programming plans at study and project level.
• Displays highly advanced knowledge regarding program, epidemiology methodologies implementation and system development life cycle concepts.
• Maintain clear documentation of analytical programming and operational definitions to support reproducible and auditable RWE studies
• Develop dashboards, reports, and presentations to communicate findings
• Work collaboratively with members of study teams to meet study and recurring report timelines

Minimum Requirements

• MS in data science, epidemiology, statistics, public health or related discipline
• At least 7 years of RWD analysis experience using healthcare claims/EMR/registry databases within the biopharmaceutical industry or provider/payer organizations
• Fluence in programming software SQL and R is required. Knowledge of SAS and/or Python would be considered an advantage
• Optum and Flatiron experience are required
• Familiarity with US and global health care coding system (e.g. ICD, CPT, HCPCS, LOINC, MedDRA) and delivery system (e.g. payers and reimbursement models)
• Experience conducting routine and advanced statistical analyses for RWE generation, leveraging time-to-event, cross-sectional, and longitudinal data
• Experience with big data analytical platforms
• Deep understanding of observational study analysis
• Able to work in a fast-paced, flexible, team-oriented environment

Our client is a global organization focused on advancing novel therapies for patients with rare diseases, with a clinical pipeline spanning multiple therapeutic areas and stages of development. Bringing a collaborative, project-driven structure, the organization is building a forward-looking team dedicated to delivering treatments that make a meaningful impact worldwide.

Currently they are seeking an Associate Director, Biostatistics to provide statistical leadership for clinical development programs. In this role, you will develop and implement statistical strategies for clinical trials and regulatory submissions, contributing to study design, data analysis, and reporting. This position offers strong visibility and requires close collaboration with cross-functional teams as well as interactions with regulatory agencies both in the U.S. and internationally. It’s a fantastic opportunity to become a part of a stable and growing group with a focus on innovation. 

Responsibilities

• Lead the full scope of Biostatistics activities for a clinical development program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans and collaborate with cross-functional teams for governance reviews.
• Lead statistical strategy for study planning and execution as a member of the Study Executive Team and Clinical Development Team.
• Provide quantitative evaluation supporting clinical trials, regulatory submissions, and related documentation.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go/No-Go criteria and probability of technical success calculations.
• Plan and oversee program-wide statistical analyses and ensure the quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities such as the FDA, EMA, and PMDA.
• Interpret analysis results and ensure accuracy in study reports and regulatory documents.
• Manage outsourcing operations or collaborate with internal statistical programmers within the program.
• Ensure the quality and timeliness of deliverables from CROs or functional service providers.
• Support or lead improvement initiatives within the department, organization, or broader pharmaceutical industry.
• Prepare abstracts, posters, oral presentations, and written reports to communicate results of clinical programs and studies to internal and external stakeholders.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related field
• PhD with 7 years of experience or MS with 9 years of experience in drug development
• Experience providing statistical leadership at the compound or indication level
• Demonstrated expertise in facilitating and optimizing clinical development strategies across early, late, or full development phases
• Experience supporting regulatory submissions
• Experience interacting with major regulatory authorities preferred
• Experience working with CROs or managing internal statistical deliverables preferred
• Demonstrated track record of innovation preferred

Core Competencies

• Familiarity with regulatory guidance and regulatory interactions
• Broad knowledge of clinical development processes
• Ability to work collaboratively and provide leadership in a matrix environment
• Strong written and verbal communication skills in English
• Good working knowledge of SAS and/or R
• Expertise across a range of statistical methodologies
• Experience applying innovative or creative statistical methods for clinical data analysis
• Familiarity with CDISC standards, statistical programming, and data standards

Location: Fully Remote

Our client is an established pharmaceutical company with a concentration in the therapeutic areas of CNS and Oncology. They are currently seeking an Executive Director, Clinical Data Science to shape and drive strategy across their global clinical development portfolio and to integrate statistical rigor with modern ML approaches. The role will define and lead global Clinical Data Science strategy, embedding advanced analytics, AI, and machine learning across the clinical development lifecycle. The ED will be responsible for driving innovation in trial design, disease modeling, biomarker discovery, imaging analytics, and precision medicine, with the goal of accelerating development timelines and improving decision quality. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Please have the following skills and background:

o Ph.D. in Biostatistics OR MS in Biostatistics in combination with a PhD in Bioinformatics, or related computational sciences.

o Deep expertise in statistical methods and their application in clinical trials, especially late phase trials.

o Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.

o Recognized thought leader in at least one Data Science discipline (e.g., AI/ML modeling, precision medicine) and experience in applying either AI, Machine Learning and/or Precision Medicine to clinical trials

o Proven experience presenting at external forums and influencing regulatory authorities.

o Strong people leadership experience in a Clinical Trials Data Science setting.

o Prior research experience in Neurology, particularly Alzheimer’s disease biomarkers (plasma, CSF, imaging), is strongly preferred.

If you possess the above, please share your CV!

Contact: Susan Devine, Director - sdevine@penfieldsearch.com

The Associate Director, Business Insights & Analytics will play a pivotal role in driving business performance through data-driven insights and strategic operational support. This position is responsible for delivering real-time, actionable analytics that enhance commercial effectiveness and support the execution of key business initiatives. Collaborating closely with cross-functional teams, the role will help shape commercial strategies, improve sales force productivity, and optimize targeting and resource allocation.

Primary Responsibilities:

• This is a hands-on role requiring direct involvement in data analysis, reporting, and the development of actionable insights to support commercial brand strategy and execution.
• Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
• Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
• Partner with Sales and business Leadership to establish territory alignments and customer targeting, applying analytical insights to enhance sales coverage and operational efficiency.
• Support field teams by responding to data and reporting needs, resolving inquiries, and delivering insights to enable daily execution.
• Collaborate with cross functional teams on the development of revenue forecasts models for respective brands.
• Generate business review reports using a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
• Support primary/secondary market research activities, ensuring outputs are analyzed and translated into actionable findings.
• Support ad hoc analyses and strategic projects by extracting insights from diverse datasets, supporting both tactical execution and Brand planning.
• Conduct promotional response analysis and develop segment-specific engagement strategies to improve brand adoption.

Qualifications & Skills:

• Bachelor’s degree in quantitative discipline such as Statistics, Mathematics, Economics, Business Analytics, or a related field.
• 4+ years of experience in commercial analytics, preferably within the pharmaceutical or life sciences industry.
• Strong proficiency in Excel
• Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
• Proven ability to translate complex data into strategic insights and clearly communicate findings to a range of stakeholders.
• Excellent project management and organizational skills; capable of handling multiple projects under tight deadlines.
• Strong interpersonal skills and a collaborative approach to working with cross-functional teams and external vendors.
• Continuously build expertise in commercial analytics, forecasting, and market research by staying current with tools, data sources, and best practices.
• Experience with Power BI or similar visualization tools is a plus.
• Familiarity with pharmaceutical data sources including prescriber data, payer plans, chargebacks, and specialty distribution metrics is preferred.
• Knowledge of CRM Platforms such as Veeva Salesforce.com, preferably Veeva is preferred.

This is an onsite role based in the Bay Area.

• Apply extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases.
• Use initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design.
• Work collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
• Work with project team members on developing clinical protocol.
• Review CRFs, CRF edit checks and CRF completion guidelines.
• Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated.
• Review ADaM specifications and verify primary and secondary efficacy endpoints.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
• Oversee programming of ADaMs and TLFs for the study.
• Responsible for one or more studies with concurrent tasks and timelines.
• Participate in the validation/QC of key study endpoint analysis and submission deliverables.
• Apply appropriate regulatory guidelines to the projects.
• Guide the successful completion of major programs, projects and/or functions.
• Develop technical and/or business solutions to complex problems.
• Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.

Please Have:

• MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience; or,
• Experience in Oncology and study Phases I-III highly preferred.
• Experience in Biotech/Pharmaceutical industry preferred.
• Experience with managing CROs in the conduct of clinical trials.
• Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
• Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
• Knowledge of appropriate regulations, industry standards and guidance documents.
• Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.
• Developed/reviewed SDTM/ADaM specifications
• Strong SAS programming knowledge.
• Complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Have good general knowledge of other related disciplines.

This is onsite role based in the Bay Area.

About the Role:

• Provide leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases.
• Apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
• Develop and/or applies statistical theories, methods and software.
• Partner in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data.
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
• Represent biostatistics function in interactions with institutional review boards, ethics committees, and health agencies.
• Work with department head to develop and implement department standards and practices.
• Direct the statistical design, conduct, and analysis of clinical trials in all phases.
• Review protocols and case report forms for soundness of trial design.
• Review and or author statistical analysis plans for all phases of a trial.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Direct the development, validation and summary of integrated safety and efficacy summaries.
• Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
• Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
• Contribute to the development of Requests-for-Proposals.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Responsible for all statistical oversight within a therapeutic area.

Please have:

• MS/MS degree in Statistics/Biostatistics and 10 years’ industry experience or PhD and 7 years.
• Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to Oncology trials.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU statistical guidelines.
• Experience in state-of-the-art data organization and statistical analyses using statistical software such as: R and SAS.
• Understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs and drug safety.
• Project management and contract negotiation with outside vendors.