Biostatistics Director

The Biostatistics Director - Drug Development will lead statistical contributions to clinical development programs. This individual will develop and implement statistical strategies for clinical trials and regulatory submissions, ensuring the timely completion and quality of statistical deliverables.

Main Responsibilities:

1. Develop and implement statistical strategies for clinical trials and regulatory submissions.
2. Lead components of biostatistical conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.
3. Author the initial statistical analysis plan for clinical trials and regulatory submissions.
4. Collaborate with regulatory authorities (e.g., FDA, EMA, PMDA) on biostatistics-related matters.
5. Ensure the accuracy of analysis results and reporting.
6. Manage outsourcing operations or work with internal statistical programmers within responsible projects.
7. Conduct reviews of deliverables to ensure quality and timeliness.
8. Be accountable for the TFL/CDISC package for study report and regulatory submission.

Responsibilities:

• PhD with 5 years of experience or MS with 8 years of experience in drug development.
• Experience providing statistical leadership at a study level.
• Strong experience in Phase II, III & IV.
• Late Phase / RWE experience is highly preferred.
• Demonstrated statistical contribution in facilitating and optimizing clinical development.
• Experience with CROs (either managing a CRO or having worked in a CRO) or managing internal deliveries preferred.
• Experience supporting regulatory interactions or submissions preferred.