Director Biostatistics Oncology

Director, Biostatistics
Full-Time | Confidential Biotech Company | Therapeutic Focus: Oncology

We are partnering with an innovative biotech company that is looking to add a Director of Biostatistics to their growing clinical development team. This role will provide statistical leadership across programs and trials from early to late phase, with a strong focus on oncology and rare disease indications.

Responsibilities:

• Lead the statistical design, conduct, and analysis of clinical trials (Phases I–IV)

• Review protocols, case report forms, and statistical analysis plans

• Perform or oversee statistical analyses and interpretation of study results

• Collaborate cross-functionally on study design, data standards, and reporting

• Support integrated summaries of efficacy and safety (ISE/ISS) for regulatory submissions

• Provide statistical support during interactions with health authorities (FDA, EMA, PMDA)

• Guide development and implementation of biostatistics standards and processes

• Oversee CROs and vendor deliverables, ensuring timelines and quality are met

Qualifications:

• Advanced degree (MS or PhD) in Biostatistics or related field

• Minimum 8–10 years of experience in clinical biostatistics within biotech or pharma

• Strong knowledge of CDISC standards (SDTM, ADaM)

• Experience supporting regulatory submissions, including NDAs/BLAs

• Proficiency in SAS; familiarity with other statistical tools (e.g., R, EAST, nQuery) is a plus

• Direct experience working on oncology trials preferred

• Strong understanding of clinical development, regulatory expectations, and cross-functional collaboration

This is a high-impact role offering strategic visibility and the opportunity to contribute to meaningful clinical programs. Candidates seeking a dynamic, mission-driven environment with strong growth potential are encouraged to apply.

To learn more or express interest, please reach out dir