Vice President of Biostatistics

Vice President, Biostatistics
Department: Biostatistics
Location: Massachusetts

About the Company
Our client is a clinical-stage biopharmaceutical company dedicated to developing precision oncology medicines. By combining innovative science with predictive diagnostics, the company is advancing novel therapies designed to transform outcomes for patients with cancer. With operations in the US and Europe, they are building a diverse pipeline across multiple stages of development.

Position Overview
We are seeking a visionary Vice President, Biostatistics to lead biostatistical efforts across clinical and diagnostic development programs. This individual will play a critical role in shaping strategy, ensuring scientific and regulatory rigor, and enabling data-driven decisions for biomarker-driven clinical trials and predictive diagnostic co-development.

Reporting to the Chief Operating Officer, this role is based in Watertown, MA.

Key Responsibilities

Statistical Leadership

• Provide leadership and oversight of biostatistical strategy for both clinical trials and diagnostic development.

Study Design & Analysis

• Collaborate with CROs and diagnostic partners on study protocols and statistical analysis plans (SAPs).

• Ensure data interpretation is scientifically sound and regulatory-compliant.

Cross-functional Alignment

• Partner closely with clinical development, biomarkers, regulatory, research, and data science teams to align statistical approaches.

Real-Time Decision Support

• Conduct hands-on modeling and analysis of critical datasets to enable timely, informed decision-making.

Regulatory Interactions

• Lead statistical contributions for regulatory submissions and agency interactions, including supporting documentation and in-person meetings.

Candidate Profile

• PhD in Biostatistics, Statistics, Mathematics, or related discipline.

• Expertise in statistical methodologies such as:

  • Mixed-effects models

  • Design of experiments (DOE)

  • Time-to-event and survival models

  • Binomial modeling

  • Stability and regression analyses

• Proficiency in R and/or SAS for applied statistical modeling.

• Strong knowledge of QSR, GCP, and FDA/EMA regulatory frameworks for diagnostics and therapeutics.

• Exceptional strategic thinking, problem-solving, and communication skills.

• Ability to thrive in fast-paced, collaborative biotech environments.

Why Join

• Be part of a mission-driven company revolutionizing precision oncology.

• Contribute to the development of first-in-class medicines paired with predictive diagnostics.

• Work with a highly interdisciplinary and innovative team spanning the US and Europe.

If you are a biostatistics leader eager to make a meaningful impact in oncology and want to contribute to groundbreaking therapies, we encourage you to apply. Join a company where your expertise will directly shape the future of cancer treatment.