• 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

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

Position Summary

We are seeking a strategic and analytically driven professional to support Medical Affairs through advanced analytics, insight generation, and data-informed decision making. This individual will play a key role in transforming complex data into actionable business insights that support launch readiness, engagement strategy, and overall Medical Affairs effectiveness.

The ideal candidate combines strong analytical and technical expertise with the ability to communicate findings in a compelling and impactful way to cross-functional stakeholders.

Key Responsibilities

Insights Analysis

• Analyze insights collected across Medical Affairs data sources to identify trends, patterns, and stakeholder sentiment.
• Synthesize findings into actionable recommendations that support strategic decision-making across cross-functional teams.
• Deliver clear and concise reporting to support business objectives and organizational priorities.

Strategic Storytelling & Communication

• Present insights, business impact, and strategic recommendations in a compelling, story-driven format to key stakeholders and leadership teams.
• Translate complex analytical findings into meaningful business narratives that influence decision-making.

Data-Informed Strategy & Analytics

• Support Medical Affairs teams with data, tools, and analytical models that inform prioritization, planning, and engagement strategy.
• Conduct ad hoc analyses to support launch preparation, strategic planning, channel engagement optimization, and Medical Expert (ME) identification and segmentation.
• Contribute to initiatives that enable successful product launches and ongoing business performance optimization.

Metrics & Impact Tracking

• Track, measure, and report Medical Affairs metrics and performance against established targets.
• Develop and define innovative approaches for measuring impact and business value.
• Identify trends and performance gaps requiring strategic course correction or optimization.

Cross-Functional Collaboration

• Partner closely with Medical Affairs stakeholders to understand business needs and develop analytical capabilities that support organizational goals.
• Collaborate with IT and other cross-functional teams on infrastructure, systems, tools, models, and reporting capabilities.

Requirements Gathering & Process Support

• Work closely with IT teams to translate business requirements into clear, concise user stories and technical requirements.
• Support the development and enhancement of scalable analytics solutions and processes.

Dashboard Development & Reporting

• Partner with IT and technical teams to develop automated, real-time dashboards integrating multiple data sources to support insight generation and impact assessment.
• Ensure reporting tools provide meaningful, user-friendly visibility into Medical Affairs performance metrics.

Therapeutic Area & Market Knowledge

• Develop and maintain expertise in relevant therapeutic areas, including respiratory disease states, as well as knowledge of Insmed and competitor products to support accurate interpretation of data and market insights.

Launch Planning Support

• Provide analytics, insights, and strategic support related to product launch planning and execution.

Qualifications

• Bachelor’s or Master’s degree in Data Science, Analytics, Business Analytics, Statistics, Computer Science, or a related quantitative field required.
• Advanced degree preferred (MBA, MS, PhD), or Life Sciences qualification (e.g., PharmD) combined with strong analytics and data experience.
• Experience supporting Medical Affairs analytics, insights generation, and launch-related initiatives within the pharmaceutical or biotechnology industry preferred.
• Strong experience with SQL, Qlik, Snowflake, Python, and advanced Excel required.
• Experience developing dashboards, reporting solutions, and analytical models using multiple data sources.
• Strong business acumen with the ability to communicate analytical findings to both technical and non-technical audiences.
• Proven ability to work collaboratively across cross-functional teams in a fast-paced environment.
• Excellent presentation, communication, and storytelling skills with the ability to influence stakeholders and drive strategic discussions.

• Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI).
• Provide strategic oversight of roles, responsibilities, and build steps for aggregate safety programming delivery.
• Serve as escalation point for complex pooled/cumulative safety analyses and urgent ad hoc safety requests.
• Maintain hands on engagement to ensure technical correctness, reproducibility, and delivery reliability for critical outputs.
• Ensure consistent processes, folder structures, and operational readiness for safety programming deliverables.
• Own and continuously improve quality management practices, including definition and monitoring of KPIs.
• Provide vendor/FSP oversight and governance, ensuring training readiness, documented expectations, and appropriate QC.
• Lead, mentor, and develop Safety Statistical Programming staff; oversee less experienced colleagues and contribute to development of standards, tools, and templates.
• Drive adoption of AI enabled and automated programming approaches to improve efficiency, consistency, and quality.

• Excellent written and verbal communication; strong influencing and negotiation skills.
• Deep knowledge of drug development, regulatory expectations, and industry standards for safety programming and reporting.
• Proven ability to lead people leaders, delegate effectively, coach performance, and support career development.
• Strong judgment and problem solving skills in complex situations; ability to prioritize critical issues.
• Demonstrated ability to work cross functionally and influence decision making.
• Education & Experience
• Bachelor’s degree or higher in Biostatistics, Computer Science, or related field with 12+ years of relevant industry experience.
• 6+ years of leadership or cross functional project management experience, including managing project teams.
• Significant line management experience with a proven record of hiring and developing high performing talent.
• Extensive experience with SAS®; experience with R and/or Python preferred.
• Demonstrated leadership in change management and standards adoption.

• Lead end to end programming strategy and execution for compound level aggregate safety reporting deliverables (DSUR, PSUR/PBRER, RMP, IBRSI).
• Provide strategic oversight of roles, responsibilities, and build steps for aggregate safety programming delivery.
• Serve as escalation point for complex pooled/cumulative safety analyses and urgent ad hoc safety requests.
• Maintain hands on engagement to ensure technical correctness, reproducibility, and delivery reliability for critical outputs.
• Ensure consistent processes, folder structures, and operational readiness for safety programming deliverables.
• Own and continuously improve quality management practices, including definition and monitoring of KPIs.
• Provide vendor/FSP oversight and governance, ensuring training readiness, documented expectations, and appropriate QC.
• Lead, mentor, and develop Safety Statistical Programming staff; oversee less experienced colleagues and contribute to development of standards, tools, and templates.
• Drive adoption of AI enabled and automated programming approaches to improve efficiency, consistency, and quality.

Capabilities & Requirements

• Excellent written and verbal communication; strong influencing and negotiation skills.
• Deep knowledge of drug development, regulatory expectations, and industry standards for safety programming and reporting.
• Proven ability to lead people leaders, delegate effectively, coach performance, and support career development.
• Strong judgment and problem solving skills in complex situations; ability to prioritize critical issues.
• Demonstrated ability to work cross functionally and influence decision making.
• Education & Experience
• Bachelor’s degree or higher in Biostatistics, Computer Science, or related field with 12+ years of relevant industry experience.
• 6+ years of leadership or cross functional project management experience, including managing project teams.
• Significant line management experience with a proven record of hiring and developing high performing talent.
• Extensive experience with SAS®; experience with R and/or Python preferred.
• Demonstrated leadership in change management and standards adoption.

We are partnering with a growing biotech organization seeking a Clinical Data Manager/Data Analyst to support ongoing and upcoming clinical programs across multiple therapeutic areas.

This role will sit within a highly collaborative clinical development team and is ideal for a hands-on, analytical Clinical Data Manager who enjoys digging into the data, identifying trends or issues proactively, and developing creative solutions to improve data quality and study execution. The client is seeking someone resourceful and technically curious — not just process-oriented — with the ability to independently explore datasets, generate meaningful reports, and surface potential issues early.

The ideal candidate will bring a blend of traditional clinical data management expertise along with strong data review, querying, and analytical skills. Experience with R, SQL, SAS, or other data interrogation and reporting tools is highly desirable.

Key Responsibilities

• Support clinical data management activities across studies from start-up through database lock
• Perform hands-on data review and exploratory analysis to identify data trends, inconsistencies, missing data patterns, and potential study risks
• Develop custom reports, listings, and data visualizations to support proactive data cleaning and study oversight
• Utilize R, SQL, SAS, or similar tools to query, analyze, and troubleshoot clinical datasets
• Partner with CROs and vendors to ensure high-quality, timely data delivery
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical, and Safety teams on data review strategies and issue resolution
• Contribute to development and review of key deliverables including:
• Data Management Plans (DMPs)
• eCRF design and completion guidelines
• Edit checks and query logic
• User Acceptance Testing (UAT)
• Data review plans and cleaning processes
• Support ongoing query management and ensure data integrity, consistency, and inspection readiness
• Assist with implementation of data standards, reporting enhancements, and process improvements
• Work independently to investigate data anomalies and recommend practical solutions in a fast-paced biotech environment

Qualifications

• BS in a scientific, technical, or clinical discipline
• Approximately 5–8 years of clinical data management experience within biotech, pharma, or CRO environments
• Strong hands-on experience reviewing and interrogating clinical trial data
• Experience using R, SQL, SAS, or other querying/reporting tools to analyze clinical data and generate custom reports
• Experience with EDC systems such as Medidata Rave, Oracle, or Veeva
• Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage
• Experience supporting Phase II and/or III clinical trials; CNS experience is a plus
• Exposure to CRO/vendor oversight
• Understanding of clinical data structures and dictionaries including MedDRA and WHODrug
• Strong critical thinking and problem-solving skills with the ability to work independently
• Resourceful, proactive, detail-oriented, and comfortable operating in a dynamic biotech environment
• Strong communication and cross-functional collaboration skills

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

• Follow department and company standard operating procedures (SOPs), forms, templates, and policies.
• On occasion, may act as senior Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team, and the client.
• Provide input for Biostatistics portion of project timelines.
• Review protocols for simple to complex studies.
• Generate randomization schedules using SAS or randomization-specific software.
• Develop and QC statistical analyses for simple to complex studies.
• Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells.
• Develop tables of summary statistics and graphics for clinical trials.
• Assist in answering deficiency letters from regulatory agencies, as required.
• Utilize SAS to validate statistician programs and results.
• Perform QC review of analyses and documents prepared by others.
• Oversee nonclinical projects, work with line manager to direct activities of other Biostatisticians.
• Coordinate with internal teams to deliver quality documents on time.
• Represent Biostatistics in client and inter-departmental meetings.
• Conduct all work in compliance with SOPs, GCP, and regulatory guidelines.
• Maintain familiarity with client/internal expectations and ensure aligned analyses and documentation.
• Stay current on global regulatory requirements (FDA, EMA, ICH, GCP).
• May participate in or lead quality improvement initiatives.
• Other duties as assigned.

Education:
Master's Degree in Statistics or a related field required.

Core Competencies

• Excellent verbal and written communication
• Ability to communicate proactively and clearly with cross-functional teams to ensure alignment on study timelines, deliverables and issues.
• Professional attitude and strong interpersonal skills
• Collaborative, client-focused mindset
• Flexible with work assignments and learning
• Strong organizational and prioritization skills
• High attention to detail
• Understanding of clinical research life cycle and regulations
• Proficient in Microsoft Word, Excel, PowerPoint

Statistical & Technical Skills

• Own statistical deliverables from design through analysis (e.g., SAPs, TFLs)
• Moderate SAS programming proficiency, including the ability to perform inferential statistical analyses
• Review programming output for accuracy and alignment with SAP
• Protocol review
• Review of aCRF / eCRF
• Creating and reviewing SAPs
• Creating and writing TFL specs and shells
• Understanding of CDISC standards (SDTM, ADaM)
• SDTM specifications and domain review
• ADaM specification writing and domain review
• ADRG (Analysis Data Reviewer’s Guide) creation and review
• Pinnacle 21 review and input

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

Brief Description:
The Principal Real World Evidence (RWE) Scientist (Contractor) will provide scientific and analytical leadership for real world evidence generation using large healthcare data sources, including administrative claims and electronic medical records (EMR). This role supports the evaluation of real world clinical and economic outcomes for company products, with a strong focus on oncology. The contractor will lead the tactical planning, execution, and oversight of RWE studies, ensuring the timely delivery of high quality, scientifically robust research outputs.

Essential Functions

• Support the design and execution of RWE studies or internal analytic projects using administrative claims and EMR data, including development of research protocols and input into statistical analysis plans (SAPs).
• Oversee end to end project execution in collaboration with external research vendors and/or internal analytics teams.
• Provide scientific guidance to ensure methodological rigor, data quality, and interpretability of study findings.
• Manage project timelines, milestones, and deliverables, ensuring adherence to agreed upon schedules.
• Coordinate and facilitate study team communication, including preparation and dissemination of interim and final study results to key stakeholders.
• Stay current with evolving RWE methodologies, regulatory expectations, and industry best practices, applying relevant innovations to ongoing projects.
• Support recurring reports, ad hoc analyses, and regulatory or scientific dissemination activities as required.

Minimum Requirements

• PhD in Epidemiology, Biostatistics, Health Outcomes Research, or a related field with 2+ years of relevant post graduate research experience; or MS in Epidemiology or a related discipline with 4+ years of applied research experience.
• Minimum 2 years of hands on experience analyzing healthcare claims and EMR databases (e.g., Flatiron or similar).
• Demonstrated experience managing RWE projects utilizing secondary data sources and/or chart review studies.
• Strong understanding of observational study design, bias mitigation, and real world data limitations.
• Proven ability to manage multiple projects concurrently in a fast paced environment.
• Experience conducting RWE research in oncology is strongly preferred.
• Excellent collaboration, communication, and stakeholder management skills.
• Ability to operate independently while working effectively within cross functional and matrixed teams.

Key Responsibilities:

• Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses.
• Provide programming support to internal teams including identifying, reporting, and resolving raw data issues
• Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
• Participate in study team meetings and address issues that may affect statistical programming.
• Support and participate in the preparation of clinical study reports, regulatory submissions, and annual DSUR and safety reports.
• Perform ad hoc analyses and data validation.
• Develop and maintain necessary programming macros or tools to effectively support all programming needs
• Develop and contribute to internal teams SOPs and working documents related to EDC studies, FDA requests, independent validation, and general statistical programming processes.

Qualifications

• Bachelor's or Master's degree in biostatistics, computer science, or related fields
• 8 years in statistical programming within the pharmaceutical, biotechnology, or CRO industry, including regulatory submissions within CNS is preferred.
• Advanced SAS programming; CDISC standards expertise; knowledge of additional programming languages (R, Python) is a plus.
• Strong Macro and tool development and validation
• Experience in BLA, NDA/sNDA submissions.
• Proficiency in additional programming languages such as R or Python, along with experience using SAS/Graph and statistical packages, is preferred.
• Strong communication skills and the ability to collaborate within cross-functional teams to manage priorities and meet deadlines are essential.

Are you a strategic statistical leader ready to shape clinical development and bring life-saving therapies to patients? Our client is a global biopharma company looking for two Directors, Biostatistics to lead statistical strategy across clinical programs and drive excellence from study design through regulatory submission. As a global biotherapeutics leader, they develop innovative therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant medicine—leveraging cutting-edge platforms including plasma fractionation, recombinant protein technology, and cell & gene therapy.

About the Role

As Director, Biostatistics, you will lead the full scope of statistical contributions across the clinical development lifecycle from early planning to submission and beyond. You’ll partner closely with Clinical Development and cross-functional teams to ensure robust, high-quality data that maximizes program success. This is a high-impact, matrix leadership role where influence, collaboration, and scientific rigor are key.

What You’ll Do

• Define and drive statistical strategy across clinical development programs, including study design, analysis, and regulatory submissions
• Lead trial design and go/no-go decision criteria, ensuring scientifically sound and efficient development plans
• Provide strategic statistical input to optimize study execution and data integrity
• Translate complex statistical findings into clear clinical and business insights
• Oversee analysis delivery, including integrated analyses and reporting across trials
• Represent Biostatistics in interactions with global health authorities (FDA, EMA, PMDA), including defending strategies and leading regulatory responses
• Collaborate cross-functionally and serve as a key partner to Program Strategy Teams 
• Provide oversight of external partners, including CROs and FSP statisticians

What We’re Looking For

• MS or PhD in Statistics or a related field
• PhD 8+/MS 10+ years of experience in pharma/biotech clinical development
• Proven leadership in statistical strategy and regulatory submissions
• Strong experience interacting with global regulatory agencies
• Expertise in clinical trial design, CDISC standards, and statistical operations
• Ability to lead through influence in a matrix environment
• Exceptional communication skills with the ability to defend ideas and drive alignment 

Location & Travel

• Hybrid role (3 days onsite per week) in Greater Boston or Philadelphia
• Occasional travel to scientific conferences

If you’re passionate about advancing science, influencing strategy, and making a meaningful impact on patients worldwide, I’d love to connect.

Apply now or message me directly to learn more! sdevine@penfieldsearch.com.

#Biostatistics #ClinicalDevelopment #PharmaJobs #BiotechCareers #Leadership #Hiring

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

• Serve as lead study biostatistician across development programs and multiple trials.
• Author statistical analysis plans (SAPs), TFL shells, and key statistical documents.
• Oversee AdaM specifications and guide the creation of high-quality, submission-ready datasets and outputs.
• Drive statistical strategy from design through interpretation and clinical study reporting.
• Conduct exploratory analyses and simulations to inform innovative trial designs.
• Partner cross-functionally with Clinical, Regulatory, Data Management, Medical Writing, and external collaborators.
• Provide statistical expertise for Health Authority interactions, publications, posters, and conference presentations.
• Contribute to the evolution of statistical standards, SOPs, and process improvements.
• Contribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches.

You should have:

• Ph.D. or M.S. in Biostatistics or Statistics
• 5+ years experience in a pharmaceutical or biotech company (PhD)
• Demonstrated understanding of Phase I to Phase IV drug development
• Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance
• Knowledge of statistical analysis software SAS and R
• NDA/BLA experience with eCTD submission is a plus
• Strong experience supporting registration-directed clinical trials
• Expertise in statistical analysis planning, CDISC standards (including AdaM), and TFL development
• Ability to collaborate effectively across clinical, regulatory, and data management teams
• Forward thinking mindset with the ability to manage multiple projects and to identify and resolve issues

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.