Our client is a biopharmaceutical company with marketed product, a robust pipeline and solid financials, and a focus in the Rare Disease area. They are currently seeking a Director of Biostatistics to play a key role in an upcoming NDA in this area, as well as to be responsible for 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. This is a hands-on role reporting to the Senior Director of Biostatistics where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, and manage CRO programmers and statisticians in preparing analysis files and performing statistical analyses. For this role, previous experience leading or supporting as a chief contributor an NDA/BLA is crucial – experience with “accelerated approvals” would be a plus.

• Lead statistical and statistical programming team 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
• Provide guidance to study team on all aspects of statistical activities; 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. They offer rapid career advancement for strong performers, an ability to own vision both for your program and your own career path and partnerships with leading institutions. The compensation package is generous including flexible PTO and excellent benefits.

Please have:

• PhD in Statistics or Biostatistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 11+ years relevant experience in the pharmaceutical/biotechnology industry
• NDA/BLA submission experience
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
• Strong analytical and problem-solving skills; ability to identify and investigate issues and causes independently and formulate potential solutions
• Excellent programming skills in SAS and/or R
• Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors

This position can be remote with travel to SF Bay Area as necessary.