Position Summary:Remix Therapeutics is seeking an experienced and strategic Vice President, Biostatistics. This role may be based in a hybrid capacity from our Watertown, MA office or remotely from the East Coast. Reporting to the Chief Medical Officer, you will provide executive leadership across biostatistics activities, with an initial focus on REM-422, our lead asset. You will build the team, set the strategy, and be accountable for the statistical framework that supports our pipeline from IND through registration and NDA submission, with a strong emphasis on oncology drug development within a biotech environment.
Key Responsibilities:- Define and execute the biostatistics strategy, setting clear goals aligned with oncology clinical development objectives.
- Provide statistical leadership in the design and execution of clinical trials across all stages of development, including registrational strategies.
- Build a high-performing team and establish processes, SOPs, and governance frameworks to ensure efficiency, standardization, and compliance across the portfolio.
- Drive innovation in statistical methods and analytics to improve decision-making and execution speed.
- Lead the design and review of clinical protocols, including statistical considerations, sample size calculations, interim analyses, randomization approaches, and study design recommendations.
- Ensure biostatistics activities support regulatory readiness, including adherence to CDISC and other regulatory standards.
- Serve as a core representative in cross-functional meetings, aligning biostatistics strategy with clinical development, regulatory affairs, and quality assurance.
- Lead interactions with health authorities (e.g., FDA, EMA, PMDA) to address statistical questions during regulatory reviews.
- Oversee CRO and vendor strategy, including vendor selection, relationship management, performance oversight, and cost optimization.
- Establish and maintain strong partnerships with external vendors and service providers to support clinical development objectives and operational excellence.
Qualifications:- Advanced degree (PhD preferred) in Biostatistics, Statistics, Data Science, or a related quantitative field.
- 15+ years of experience in clinical biostatistics, with significant experience in oncology drug development within biotech or biopharmaceutical companies.
- Demonstrated experience supporting clinical programs from IND through NDA/BLA submission and regulatory approval, including registrational trials.
- Prior experience leading or contributing to regulatory interactions and submissions with global health authorities, including FDA and EMA.
- Demonstrated leadership and people management experience with cross-functional teams.
- Familiarity with clinical data standards (e.g., CDISC SDTM/ADaM).
- Strong understanding of regulatory requirements and clinical development processes.
Salary Range$293,000 - $358,000 USD
This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.
