Associate Director, Biostatistics

Position Purpose:

The Associate Director, Biostatistics is a key contributor to clinical development, providing statistical leadership across all phases of clinical trials (Phases 1-4).  They will join a highly collaborative Clinical Development team and partner cross-functionally with Data Management, Clinical Development Operations, and external stakeholders including consultants, CROs, and Key Opinion Leaders.

The Associate Director, Biostatistics, will have proven leadership ability in a fast-paced environment, influencing study design and data analysis while ensuring high-quality deliverables. This position will report to the Director of Biostatistics.

Key Responsibilities:

• Lead statistical strategy for clinical trials from protocol development through study reporting, including study design, endpoint selection, sample size determination, and statistical methodology.
• Author and oversee Statistical Analysis Plans (SAPs) and contribute to Clinical Study Reports (CSRs), ensuring accuracy, quality and regulatory readiness.
• Analyze and interpret clinical trial data; oversee validation and quality control of TLFs; communicate statistical results and concepts clearly to cross-functional and non-statistical audiences.
• Partner with cross-functional teams to provide strategic statistical guidance and input across programs from Phase 1 through Phase 3, including regulatory submissions (e.g. New Drug Applications) and post-marketing studies.
• Contribute to key clinical development and regulatory documents including Clinical Development Plans, protocols, synopses, Investigator Brochures, submissions, and scientific publications.
• Represent Biostatistics in internal and external forums, including, for example, Investigator Meetings, Advisory Boards, and interactions with Key Opinion Leaders.
• Coordinate statistical and programming activities with CRO partners to ensure high-quality and timely deliverables.
• Collaborate closely with Clinical Development, Data Management, Clinical Development Operations, Medical Writing, and other internal departments to achieve alignment across departments.
• Maintain current knowledge of relevant issues related to statistics and trial design, drug development, Health Authority regulations, and competitive trends to inform strategic decision-making.

Required Skills & Experience:

• Ph.D. in Statistics or Biostatistics with 6+ years of industry experience, or Master’s degree with 8+ years in a clinical trial setting.
• Strong Knowledge of FDA, EMA, and ICH guidance for drug
• Excellent working knowledge of CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in STDM, ADaM, and SEND data standards and associated
• Demonstrated experience across Phase 1 to 3 clinical trial design, execution and data interpretation in both efficacy and safety. Submission experience is a plus.
• Experience working collaboratively with CROs to ensure high-quality and timely deliverables
• Excellent interpersonal skills, ability to convey statistical concepts and results to non-statisticians.
• Proficiency in SAS programming and at least one other programming language such as R for statistical analysis.
• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required.
• Excellent verbal and written communication
• Strong attention to detail and process orientation.

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid currently based in Bedford and will later be based in Waltham.

Travel:

This position will require approximately 5% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $195,000 - $215,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).