Senior Director, Biostatistics, Clinical Operations

AskBio Inc. • Durham, NC

2d • Hybrid

About The Position

This role is a secondment opportunity at AskBio, available for a time period determined by leadership at both Bayer and AskBio, typically ranging from one to two years. It offers a chance to broaden experience, expand knowledge, and contribute to AskBio’s mission of advancing gene therapy. The Senior Director, Biostatistics provides technical leadership and operational oversight for the development of clinical strategies, and the design, implementation, and reporting of non-clinical, CMC, and clinical development programs and associated studies and clinical trials. This role also performs peer review of clinical trial designs and reports for other biostatisticians. The position collaborates with cross-functional teams, guides statisticians for high-quality deliverables, supports regulatory interactions, and represents the company on statistical issues for global drug approvals. This is a US hybrid position based in RTP, NC, or Philadelphia, Ohio, reporting to the Head, Biometrics, Clinical Operations.

Requirements

• Ph.D. or M.S. in Statistics or a related field.
• 10+ years of pharmaceutical experience in a pharmaceutical or biotech R&D environment.
• Knowledge of cardiovascular, metabolic, kidney, CNS, and/or rare disease programs.
• Previous experience preparing and submitting New Drug Applications to regulatory agencies.
• Strong knowledge of design of experiments, clinical trial design concepts or CMC statistics, drug regulation, and management of the statistical function.
• Extensive experience with SAS and/or R.
• Excellent communication skills.
• Experience in CRO selection, contracting, and management.
• Excellent leadership and interpersonal skills, with the ability to build credibility and trust inside and outside the Company.

Nice To Haves

• Experience with adaptive and Bayesian study design simulation techniques.
• Experience in rare diseases and/or gene therapy.

Responsibilities

• Responsible for all deliverables related to statistical content.
• Develop and lead the statistical strategy for assigned clinical development programs, ensuring that individual study designs, endpoints, analysis methods, and evidence-generation plans collectively support key development decisions, regulatory objectives, and the target product profile.
• Provide leadership on estimated development, handling of intercurrent events and missing data, multiplicity control, sensitivity analyses, and other statistical strategies needed to support interpretable and regulatory defensible conclusions.
• Provide guidance and management to statisticians, programmers, and data managers to ensure high-quality and timely deliverables.
• Advise and influence senior leadership and functional leads on biostatistics strategies and functional issues that have a business impact.
• Oversee the biostatistics function at CROs and manage scopes of work and relationships with external statistical consultants as needed.
• Manage resources, set priorities, and ensure consistency and adherence to standards.
• Collaborate on protocol development, including study design, endpoint selection, and power and sample size assessments.
• Take responsibility for statistical analysis plans, data analysis, and clinical study report content.
• Support Data Monitoring Committee charters and meeting preparation.
• Represent the Company and the Biostatistics function in written and in-person interactions with the FDA, EMA, and other health authorities.
• Support regulatory submissions and interactions, including IND and BLA filings, and support potential partnering requests.
• Serve as an integral member of cross-functional project teams and provide statistical input to clinical development plans, protocols, synopses, investigator brochures, regulatory submissions and responses, scientific publications, and presentations.
• Lead statistical planning and execution for regulatory submissions, including integrated summaries of safety and effectiveness, submission-ready analyses and datasets, responses to health-authority questions, and preparation for regulatory inspections and advisory committee meetings, as applicable.
• Establish and maintain risk-based quality-control, validation, documentation, and governance processes for statistical deliverables, ensuring that analyses are reproducible, auditable, inspection-ready, and compliant with applicable GCP and regulatory requirements.
• Develop solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams and communicate solutions cross-functionally.
• Contribute to the creation and maintenance of departmental SOPs and standardization efforts, and provide training on statistical topics.
• Maintain current knowledge of developments in statistics, drug development, and regulatory guidance.
• Participate in due diligence evaluations of study designs and clinical trial data for external partnership opportunities as needed.
• Assist with business development activities at key conferences and industry meetings.
• Support scientific and medical meetings, including investigator meetings, advisory boards, DMCs, SABs, and interactions with key opinion leaders.
• Present at industry conferences representing AskBio.
• Participate in vendor evaluation, selection, and management.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior