Biostatistics Director

Our client, a leading biopharmaceutical company, is seeking a highly skilled Director or Senior Director of Biostatistics to join their team. As a key member of the clinical development team, you will be responsible for leading statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

• Lead a team of statisticians and statistical programmers on product level
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies
• Develop and maintain SAPs, including derived variables, templates of statistical tables, figures, and listings
• Collaborate closely with data manager to ensure high-quality data
• Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
• CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines
• Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities
• Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities; attend team meetings

The company culture emphasizes putting patients first and upholding strict ethical standards. They encourage team members to be entrepreneurial, driving toward practical solutions with an ownership mindset.

We are looking for a highly skilled professional with a Ph.D. in statistics or biostatistics and 8+ years of relevant experience in the pharmaceutical/biotechnology industry for the Director position. Additional experience is required for the Senior Director position. The ideal candidate will have strong knowledge of statistical methodologies, current drug development trends, and regulatory environments. Excellent programming skills in SAS and/or R are also required.

This is a remote position with occasional travel to the SF Bay Area as necessary.