Senior Director, Biostatistics, Clinical Operations

Position Summary

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. In addition, this role performs peer review of clinical trial designs and reports for other biostatisticians in the Biometrics group. The role collaborates closely with cross-functional teams across all phases of drug development, provides guidance and management to statisticians to ensure high-quality and timely deliverables, supports regulatory interactions, and serves as the statistical representative in defense of the company’s position and approach on statistical issues and global drug approvals. This is a US hybrid position which can be based in RTP, NC, Philadelphia, Ohio and will report to the Head, Biometrics, Clinical Operations.

Job Responsibilities

• Responsible for all deliverables related to statistical content.
• 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.
• 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.

Minimum 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.

Preferred Skills & Abilities

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