• Author and lead the development of regulatory submission documents, including: Regulatory briefing books, eCTD modules and other complex regulatory documentation
• Develop document strategies, structure, and messaging aligned with regulatory objectives.
• Serve as a SME for regulatory writing across programs.
• Act as the program lead for assigned writing projects, coordinating cross-functional input.
• Translate complex scientific and clinical data into clear, compliant regulatory narratives.
• Collaborate with clinical, regulatory, biostatistics, and program leadership teams.
• Ensure documents meet regulatory agency expectations and submission standards.

• Extensive regulatory medical writing experience within pharma or biotech
• Proven experience authoring regulatory submission documents, including briefing books and eCTD modules
• Demonstrated ability to develop document strategies and lead authoring from concept to submission
• Strong experience handling highly complex regulatory documentation
• Excellent communication, leadership, and stakeholder management skills
• Ability to function as a program lead across cross-functional teams

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: Greater Philadephia OR Boston
Work Model: Hybrid (3 days onsite per week)
Reporting To: Director, Biostatistics

Our client is an organization accelerating innovation to deliver greater impact for patients with Rare Diseases; their pipeline portfolio is diverse and ranges from early to late phase. With a project-led structure and a focus on collaboration, they’re building a future-ready team committed to developing therapies that make a meaningful difference worldwide.

They are currently looking for a Senior Biostatistician to provide statistical expertise supporting clinical development programs. In this role, you will contribute to the statistical strategy for clinical trials and regulatory submissions and support statistical activities across study design, data analysis, reporting, and submission preparation.

Responsibilities

• Contribute to statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Provide statistical support across data collection, analysis, reporting, and submission preparation.
• Develop and ensure the timely completion and quality of statistical analysis plans.
• Support interactions between Biostatistics and regulatory authorities such as the FDA, EMA, and PMDA.
• Interpret analysis results and ensure accuracy in statistical reporting.
• Collaborate with internal statistical programmers or manage outsourced programming activities within projects.
• Ensure quality and timeliness of deliverables from CROs or functional service providers (FSPs) and conduct review of outputs.
• Prepare and oversee TFL and CDISC packages for clinical study reports and regulatory submissions.
• Support process improvement initiatives and contribute to statistical infrastructure, standards, and scientific consulting.

Qualifications

• PhD in Biostatistics, Statistics, or a related field, with 1–2 years of experience in drug development, MS 3+ years in industry
• Advanced knowledge and training in the application of statistical methodologies within clinical development
• Direct regulatory interaction experience is strongly preferred

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

The Senior Biostatistician is responsible for having a working knowledge of all related processes with the ability to independently lead a study, support analysis, and provide high-quality documents to support sponsors' research programs.

The ideal candidate is a Biostatistician with strong applied SAS skills (including TFLs, inferential analyses, and randomization) who can collaborate cross-functionally with the programming team, while also independently contributing to statistical deliverables and quality review.

Experience working on Phase 1 clinical trials is highly desirable, particularly with first-in-human and dose-escalation studies, including PK/PD data and early safety endpoints.

Responsibilities

• 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

• Lead statistical programming activities across global studies (EU and China exposure preferred)
• 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

• Strong expertise in CDISC standards, including ADaM and SDTM
• Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables
• 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

• 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

• West Coast: ~6-hour overlap with China; flexibility for late afternoon/evening PST collaboration

• East Coast: ~6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:00–11:00 AM EST)

The role is approximately 50% traditional biometrics programming and 50% AI-driven workflow development, making it ideal for candidates who combine strong SAS expertise with genuine curiosity and hands-on experience leveraging AI in clinical programming environments.

This is not a heads-down SAS-only role. They are looking for someone who communicates well, takes ownership, and can help scale AI initiatives across the organization.

Key Responsibilities

Clinical Programming (50%)

• Develop clinical datasets and generate Tables, Listings, and Figures (TLFs)
• Perform QC and validation of statistical outputs
• Support biometrics deliverables aligned with regulatory standards
• Partner closely with biostatistics and medical affairs (including publications support)
• Contribute to programming documentation and project timelines

AI Working Group Contributions (50%)

• Actively use ChatGPT (Enterprise preferred) to enhance programming efficiency
• Apply advanced prompting techniques to refine AI-generated outputs
• Support AI-driven workflows for:
  • QC automation
  • Table generation
  • Coding assistance (SAS/R/Python)
• Collaborate on proof-of-concept initiatives and internal AI tools
• Help evolve and scale AI adoption across biometrics

Required Qualifications

Technical

• Strong SAS programming experience within clinical trials
• Hands-on experience with dataset development and TLF production
• Solid understanding of regulatory/statistical outputs
• QC programming experience
• Exposure to biostatistics concepts and clinical data standards

AI / Innovation (Required – not optional)

• Practical experience using ChatGPT in a professional setting (Enterprise preferred)
• Strong prompting skills (ability to iterate and refine outputs)
• Demonstrated interest in AI workflow integration
• Python exposure is a plus
• Experience exploring AI agents is a strong plus

Soft Skills (Critical Success Factors)

Must demonstrate:

• Clear communication in group settings
• Proactive project ownership and follow-through
• Strong status reporting and stakeholder updates
• Accountability and independent workload management
• Confidence contributing in collaborative environments

Technical Environment

• SAS (primary)
• Some R for graphics (not a major focus)
• Increasing use of LLM-assisted SAS/R generation

Nice-to-Haves

• AI agent experience
• Real-world data exposure
• Strategic curiosity around AI applications
• Comfort operating in evolving workflows

Essential Functions

• Support the design, review, and execution of epidemiological research projects using administrative claims data/ EMR or other appropriate data sources, including development of protocols, contributing to statistical analysis plans (SAPs), reviewing and interpreting study results, and abstract and manuscript development.
• Stay current with research on epidemiological methodology and its applications as pertinent to project needs.
• Oversee and manage study team communication, project milestones, dissemination of results to key members, including internal and external collaborators.
• Work collaboratively with members of study teams to meet study and recurring report timelines.

Minimum Requirements

• PhD degree in epidemiology (or similar area) with 2+ years' research experience or MS in epidemiology (or similar area) with 4+ years research experience
• At least 2 years with analytic experience of healthcare claims databases/EMR
• Deep understanding of observational study design and analysis and ability to lead multi-disciplinary teams required to support program, project and contract management and financial reporting
• Experience designing and analyzing epidemiological studies, from protocol development through public dissemination (e.g. abstracts and manuscripts)
• Previous experience with safety studies (PASS)

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

Biostatistician

We are seeking an experienced Contract Biostatistician to provide part-time statistical consulting support for a growing medical device company. This role will focus on the design, analysis, and interpretation of clinical studies involving human subjects, with an emphasis on diagnostic device performance and sensitivity testing. The ideal candidate has prior experience working with medical device clinical data and can operate independently in a fast-paced, resource-lean environment.

Key Responsibilities

• Provide statistical expertise for medical device studies involving human patients, including study design, analysis planning, and interpretation of results
• Support diagnostic device studies, including evaluation of sensitivity, specificity, and other performance characteristics
• Conduct and review sensitivity analyses to assess robustness of study results
• Develop or review statistical analysis plans (SAPs) for device clinical studies
• Analyze clinical and diagnostic data and summarize results for internal teams and external stakeholders
• Collaborate with clinical, regulatory, and engineering teams to support regulatory submissions and study reporting
• Provide ad hoc statistical consultation as needed

Required Qualifications

• Prior experience supporting medical device clinical studies involving human subjects
• Hands-on experience with diagnostic studies, including sensitivity analyses
• Strong knowledge of statistical methods relevant to medical device evaluation
• Ability to work independently as a consultant and communicate findings clearly to non-statistical stakeholders

Preferred Qualifications

• Master’s degree in Statistics, Biostatistics, or a related field
• Experience supporting studies intended for regulatory submission (e.g., FDA, notified bodies)
• Familiarity with common statistical software (e.g., SAS, R, or equivalent)

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.

Role is located in Washington, DC and is fully onsite

Salary - $175k-240k base + bonus

Fantastic benefits package including equity and unlimited PTO

Relocation is available

Our client is seeking a highly experienced Director of Biostatistics to lead statistical strategy and execution across their clinical development programs. This is a key leadership role with broad influence on study design, data integrity, regulatory submissions, and the growth of the Biostatistics function. You will serve as the lead statistician for multiple clinical studies and have the opportunity to drive clinical trial design, protocol development, and creation of robust Statistical Analysis Plans (SAPs). You will also manage internal statisticians, contract resources, programming teams, and CRO biostatistics support and support regulatory interactions, responses, and submission-related activities. The role can also come in at the Associate Director level.

Here you’ll have the opportunity to influence clinical development at a strategic level, mentor talented statisticians, and contribute to meaningful innovations that impact patient lives.

If you have:

• PhD in Biostatistics or Statistics

• 5+ years of clinical trial experience (pharmaceutical or CRO)

• Deep knowledge of clinical trial methodology, ICH/GCP, and regulatory expectations

• Strong, hands-on experience with SAS and R / S

• Exceptional communication, leadership, and organizational skills

• Ability to collaborate effectively in a dynamic, fast-paced environment

Please reach out at sdevine@penfieldsearch.com!

This is a high-impact, on-call opportunity for a statistician who thrives in early-phase clinical research and wants to contribute strategic value without committing to a full-time role. While initially fractional, the position may evolve based on study load and team needs—making it ideal for experienced professionals looking to partner deeply without traditional constraints.

Position Summary:

The Scientific Manager of Biostatistics is responsible for supporting and advising clients on all aspects of PD data collection and analysis.

This role involves developing the PD analysis sections of the SAP and shells for tables, listings, and figures (TLFs), consulting with clients on PD analysis strategies, and ensuring data quality and accuracy through review and validation.

This position requires strong pharmacodynamic (PD) endpoint expertise, including extensive work with subjective measures, VAS pain scales, and biomarker-driven analyses.

Responsibilities:

• Develop the PD Analysis section of the Statistical Analysis Plan (SAP) and corresponding PD shells.
• Consult with clients on PD analysis strategies and subject allocation.
• Provide statistical design and methodology support for PD-related endpoints.
• Ability to apply solid judgment to select and implement appropriate statistical techniques based on study objectives, data characteristics, and regulatory expectations
• Review PD tables, figures, and listings (TFLs) to ensure quality and consistency.
• Collaborate cross-functionally with internal teams and clients.
• Participate in team meetings and strategic planning discussions.

Skills:

• Must be a clear, concise, and effective communicator—able to translate complex statistical concepts into actionable insights for clinical and cross-functional teams.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Solution-focus and ability to creatively solve problems and resolve issues.
• Ability to take initiative and use sound judgment.
• Ability to acquire and apply knowledge quickly.
• Flexible attitude and an ability to effectively prioritize.
• Deep understanding of clinical research, statistical principles, drug development process, and applicable regulatory guidelines as they relate to complex phase I studies of CNS-acting compounds.
• Significant Phase I clinical trial experience, including Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study designs, execution, and analysis.
• Strong technical aptitude and expertise in statistical analysis principles specific to PD data.
• Working knowledge of SAS programming.
• Good computer skills (Microsoft Word, Excel, and PowerPoint) and ability to understand and adapt to various information technology (IT) systems.

Experience with Specific Data Types:

• VAS (Visual Analog Scales)
• Pulmometry (Lung Function Testing)
• Psychedelic-related data and endpoints

Education and Experience:

• Master's degree in Statistics, Biostatistics, or a related field (Ph.D. preferred).
• Minimum of 5 years of relevant experience as a statistician, with a focus in pharmacodynamic data.
• Experience with CNS and early-phase studies preferred.
• Prior CRO experience is a plus.

Location: Palo Alto, CA - onsite

*** Please note - no relocation is offered for this role, so candidates must live in the Bay Area

Our client is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. Focusing on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally, this role is on-site at the company’s headquarters in Palo Alto, CA, so local candidates are preferred. The organization’s three lead product candidates are in Phase III with BLAs to follow in the near term, so there is a key opportunity here to play an integral role in submission activity.

Currently they are seeking a dedicated and detail-oriented Manager, Data Management to contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready data. The ideal candidate will bring strong hands-on experience and a collaborative mindset, working closely with cross-functional teams to drive successful trial execution and regulatory submissions.

• Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
• Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
• Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
• Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
• Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
• Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting.
• Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).

Please have :

• Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
• Experience managing study-level data management activities and working with external vendors.
• Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
• Demonstrated experience supporting regulatory submissions is a plus.
• Strong problem-solving, organizational, and communication skills.

This is a visible role in a smaller organization where you will have the opportunity to have real impact in this meaningful field.

• Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews
• Lead statistically robust study design and analysis to optimize manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance
• Build and maintain reproducible data science communication products including interactive dashboards, analytic reports, and other deliverables that effectively communicate complex findings to diverse stakeholders
• Collaborate using Git workflows for version control and code management
• Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
• Collaborate closely with scientists on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing

If you have:

• PhD or MS in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 2+ years (PhD) or 5+ years (MS) of industry experience
• Strong foundation in applied statistics, statistical modeling, and method selection
• Demonstrated experience in computational problem-solving within a scientific research setting
• Track record of developing analysis pipelines and reports
• Experience in scientific collaborations within therapeutics development with an ability to translate between scientific and computational domains
• Experience with manufacturing statistics (process variability, specification setting, quality metrics)
• Advanced proficiency in R or Python
• Practical experience with Git workflows
• Familiarity with data engineering and basic cloud tools (AWS)
• Experience with building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)
• Experience with Omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)
• AI/ML application development
• Familiarity with immunology and immune cell biology
• Working understanding of molecular mechanisms in cancer and cell therapy

 Please reach out at sdevine@penfieldsearch.com

Contact: Lauren Scutero - lscutero@penfieldsearch.com

This is an onsite role based in Washington, D.C.

Job Summary:
We are seeking an Associate Director, Biostatistics, who will be responsible for providing statistical expertise to all company studies. S/he is primarily responsible for the development of protocol and statistical analysis plan, data analysis, data presentation and report writing. S/he may also be responsible for providing mentorship to junior biostatisticians.

Primary Responsibilities

• Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)
• Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups
• Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others.
• Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities.
• Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected.
• Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.

Requirements

• Ph.D. in Biostatistics or statistics
• At least 4 years of pharmaceutical clinical trial experience
• In-depth knowledge of clinical trials methodology, regulatory requirements, statistics
• Comprehensive experience of SAS programming and R/S language
• Ability to effectively collaborate in a dynamic environment
• Excellent practical, organizational, interpersonal, oral and written communication skills are a must.

Key Responsibilities

• Build and run clinical trial simulations to support study design decisions.
• Perform advanced data wrangling, cleaning, and transformation in R and PostgreSQL.
• Work across modern data platforms (Databricks, PostgreSQL, etc.) to integrate, query, and prepare datasets.
• Develop reproducible, well-documented R code for modeling, analysis, and reporting.
• Leverage Seql (Posit’s new AI-assisted R/Python tool) to accelerate analysis and automate code generation.
• Collaborate with biostatistics, data science, and engineering teams to optimize workflows and improve data accessibility.
• Support onboarding and integration of new team members into R-based and database environments.

Required Skills & Experience

• Fluency in R for programming, data manipulation, and simulation.
• Strong SQL experience (preferably PostgreSQL) for querying and data integration.
• Proven experience with clinical trial simulations, adaptive/study design, or statistical modeling.
• Expertise in data wrangling and structuring messy datasets for analysis.
• Comfort working in modern data ecosystems (e.g., Databricks, cloud data warehouses, pipelines).
• Excellent documentation and communication skills, with a collaborative, problem-solving mindset.

Nice to Have

• Familiarity with Seql (Posit’s AI-assisted R/Python tool).
• Experience in biostatistics, clinical research, or pharma/biotech environments.
• Exposure to Bayesian simulation, Monte Carlo modeling, or reproducible R workflows (e.g., R Markdown, Quarto).

Ideal Candidate Profile
This role is perfect for someone who sits between a data engineer and a biostatistician — an independent problem solver who can connect analytical goals with the technical backbone needed to achieve them. You’ll thrive if you’re comfortable in R, fluent in SQL, and excited to explore emerging tools that make working with data faster, smarter, and more intuitive.

$75-$100 hourly W2 / $85-$110 hourly 1099, commensurate with experience

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.