DescriptionWe are seeking an experienced and strategic Director, Biostatistics to lead biostatistical support for clinical development programs and regulatory submissions. This leadership role will provide scientific and operational oversight across all phases of clinical trials, ensuring rigorous statistical methodology, data integrity, and regulatory compliance. The ideal candidate brings deep expertise in biostatistics, a collaborative approach, and proven experience leading cross-functional teams through global regulatory submissions.
Responsibilities- Provide statistical leadership across clinical development programs, including study design, protocol development, SAP creation, and analysis planning.
- Oversee statistical deliverables for clinical trials from early phase through late-stage development and regulatory submission.
- Partner with Clinical, Regulatory, Data Management, and Medical Writing teams to ensure statistically sound study design and high-quality deliverables.
- Lead the development and review of key documents, including statistical analysis plans, clinical study reports, and regulatory filings (e.g., NDA, BLA, MAA).
- Represent Biostatistics in interactions with regulatory agencies, including preparation of responses and participation in meetings.
- Manage external CROs/consultants to ensure on-time, high-quality statistical support and deliverables.
- Drive process improvements, innovation, and adoption of best practices in statistical analysis and data visualization.
- Ensure compliance with industry and regulatory standards including ICH, GCP, FDA, EMA, and CDISC.
Education / Qualifications- PhD or Master's degree in Biostatistics, Statistics, or a related quantitative field.
- 10+ years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry, including experience in late-phase clinical trials and regulatory submissions.
- Proven experience leading teams and managing complex clinical development programs.
- Strong knowledge of statistical methods for clinical trials, regulatory guidelines, and CDISC standards (SDTM, ADaM).
- Proficiency in statistical software (e.g., SAS, R).
- Excellent communication, leadership, and project management skills.
- Experience with global regulatory interactions and submissions preferred.
- Ophthalmology experience preferred.
