Associate Director Biostatistics

Senior Manager / Associate Director / Director, Biostatistics

Location: Watertown, MA | Hybrid

Relocation Assistance Available

Position Overview

We are partnering with a clinical-stage biotechnology company seeking an experienced Biostatistician to join its growing Biometrics organization. The team is open to considering candidates at the Senior Manager, Associate Director, or Director level , depending on experience.

This individual will serve as a Study/Program Lead Statistician , taking ownership of statistical strategy and execution across clinical development programs. The position offers significant visibility and the opportunity to contribute from early-stage development through later-phase clinical trials and regulatory activities .

Experience within Immunology is preferred; however, candidates from other therapeutic areas with strong clinical development and statistical leadership experience are encouraged to apply.

Key Responsibilities

• Serve as the lead statistician for assigned clinical studies and/or development programs.
• Represent Biostatistics/Biometrics on cross-functional study and program teams.
• Provide strategic statistical input into clinical development plans and study designs.
• Lead statistical activities across Phase I–III clinical trials , with strong early-phase experience required.
• Author statistical sections of clinical protocols and provide statistical review of other study documentation.
• Develop and review Statistical Analysis Plans (SAPs) and statistical output shells.
• Contribute to integrated analyses, including ISS and ISE , as applicable.
• Provide statistical input into CRF design and clinical database development.
• Oversee and perform quality review of statistical programming deliverables.
• Author statistical sections of Clinical Study Reports and support interpretation of clinical trial results.
• Contribute to regulatory submissions, agency interactions, and inspection readiness.
• Manage statistical deliverables performed by CROs and external vendors.
• Support scientific publications, presentations, and other clinical development activities.
• Provide mentorship and potentially manage direct reports depending on level.

Qualifications

• Advanced degree in Statistics, Biostatistics, or a related quantitative field .
• Approximately 6+ years of clinical trial experience within biotechnology or pharmaceutical environments; level will be determined based on experience.
• Phase I clinical trial experience is required , along with broader experience supporting clinical development across Phases I–III .
• Strong knowledge of statistical methodologies used in clinical trials.
• Hands-on SAS programming experience is required.
• Strong understanding of FDA, EMA, and ICH guidelines and their application to clinical development.
• Experience contributing to clinical protocols, SAPs, CSRs, regulatory submissions, and statistical deliverables.
• Experience overseeing CROs and/or outsourced statistical programming activities.
• Ability to effectively communicate statistical concepts to clinical and non-statistical stakeholders.
• Strong organizational skills with the ability to manage multiple studies and priorities in a fast-paced biotech environment.
• Immunology experience is highly preferred , though strong candidates from other therapeutic areas will be considered.
• Experience with R, Python, EAST, or nQuery is a plus.

Additional compensation may include annual bonus, equity, and comprehensive benefits.

Location & Relocation

Candidates who are not currently local to the Greater Boston area are encouraged to apply, as relocation assistance is available .

This is an urgent hire , and the team is actively interviewing qualified candidates.