Associate Director Biostatistics Oncology

Associate Director, Biostatistics
Full-Time |Therapeutic Focus: Oncology
Location: Onsite 3-5x/week | Greater Philadelphia Area or San Francisco Bay Area

We are partnering with an innovative biotech company that is looking to add an Associate Director of Biostatistics to their growing clinical development team. This high-impact role offers strategic visibility and the opportunity to contribute across all phases of development, with a strong focus on oncology and rare disease indications.

Responsibilities:

• Provide statistical leadership for the design, execution, and analysis of clinical trials (Phases I–IV)

• Review protocols, case report forms (CRFs), and statistical analysis plans (SAPs)

• Oversee or conduct statistical analyses and interpret study results

• Collaborate with clinical, regulatory, and data management teams on study design, data standards, and reporting

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

• Participate in regulatory interactions with health authorities (FDA, EMA, PMDA)

• Help define and implement biostatistics standards and processes

• Manage CROs and vendors to ensure high-quality, timely deliverables

Qualifications:

• Advanced degree (PhD) in Biostatistics or related field

• 6–10 years of experience in clinical biostatistics within biotech or pharma

• Proficiency in SAS; experience with R, EAST, or nQuery is a plus

• Solid knowledge of CDISC standards (SDTM, ADaM)

• Hands-on experience with regulatory submissions (e.g., NDA/BLA)

• Oncology experience strongly preferred

• Strong communication skills and ability to work cross-functionally in a collaborative environment

This is an onsite role (3 days per week) with flexibility to be based in either the San Francisco Bay Area or the Greater Philadelphia Area. Relocation assistance is available for qualified candidates.

If you're interested in learning more, please apply!