Associate Director, Biostatistics
Stoke Therapeutics
4 months ago
Remote friendly (Bedford, MA)
United States
Clinical Research and Development
Position Purpose:
- Provide statistical leadership across all phases of clinical trials (Phases 1–4) and contribute to clinical development as part of a collaborative team.
Key Responsibilities:
- Lead statistical strategy from protocol development through study reporting (study design, endpoint selection, sample size determination, statistical methodology).
- Author and oversee Statistical Analysis Plans (SAPs) and contribute to Clinical Study Reports (CSRs) with accuracy, quality, and regulatory readiness.
- Analyze and interpret clinical trial data; oversee validation and quality control of TLFs; communicate statistical results to cross-functional and non-statistical audiences.
- Provide strategic statistical guidance across programs (Phase 1–3), including regulatory submissions and post-marketing studies.
- Contribute to clinical development and regulatory documents (Clinical Development Plans, protocols, synopses, Investigator Brochures, submissions, scientific publications).
- Represent Biostatistics in internal/external forums (e.g., Investigator Meetings, Advisory Boards, Key Opinion Leader interactions).
- Coordinate statistical and programming activities with CRO partners.
- Maintain current knowledge of statistics/trial design, drug development, Health Authority regulations, and competitive trends.
Required Qualifications:
- Ph.D. in Statistics/Biostatistics with 6+ years industry experience, or Master’s degree with 8+ years in a clinical trial setting.
- Strong knowledge of FDA, EMA, and ICH guidance for drug development.
- CDISC requirements expertise for regulatory submissions (STDM, ADaM, SEND).
- Demonstrated Phase 1–3 clinical trial design, execution, and data interpretation (efficacy and safety); submission experience a plus.
- Experience collaborating with CROs for timely, high-quality deliverables.
- Excellent interpersonal skills; ability to convey statistical concepts to non-statisticians.
- SAS programming proficiency and at least one other language (e.g., R).
- Experience adhering to SOPs and regulatory guidelines.
- Excellent verbal and written communication; strong attention to detail and process orientation.
Compensation & Benefits:
- Anticipated salary range: $195,000–$215,000; annual bonus and equity participation.
- Benefits include medical/dental/vision insurance; life and long-/short-term disability; paid parental leave; 401K with match; unlimited vacation; tuition assistance; ESPP participation.
Application Instructions:
- Apply directly via the Career Center: https://www.stoketherapeutics.com/careers/
- Provide statistical leadership across all phases of clinical trials (Phases 1–4) and contribute to clinical development as part of a collaborative team.
Key Responsibilities:
- Lead statistical strategy from protocol development through study reporting (study design, endpoint selection, sample size determination, statistical methodology).
- Author and oversee Statistical Analysis Plans (SAPs) and contribute to Clinical Study Reports (CSRs) with accuracy, quality, and regulatory readiness.
- Analyze and interpret clinical trial data; oversee validation and quality control of TLFs; communicate statistical results to cross-functional and non-statistical audiences.
- Provide strategic statistical guidance across programs (Phase 1–3), including regulatory submissions and post-marketing studies.
- Contribute to clinical development and regulatory documents (Clinical Development Plans, protocols, synopses, Investigator Brochures, submissions, scientific publications).
- Represent Biostatistics in internal/external forums (e.g., Investigator Meetings, Advisory Boards, Key Opinion Leader interactions).
- Coordinate statistical and programming activities with CRO partners.
- Maintain current knowledge of statistics/trial design, drug development, Health Authority regulations, and competitive trends.
Required Qualifications:
- Ph.D. in Statistics/Biostatistics with 6+ years industry experience, or Master’s degree with 8+ years in a clinical trial setting.
- Strong knowledge of FDA, EMA, and ICH guidance for drug development.
- CDISC requirements expertise for regulatory submissions (STDM, ADaM, SEND).
- Demonstrated Phase 1–3 clinical trial design, execution, and data interpretation (efficacy and safety); submission experience a plus.
- Experience collaborating with CROs for timely, high-quality deliverables.
- Excellent interpersonal skills; ability to convey statistical concepts to non-statisticians.
- SAS programming proficiency and at least one other language (e.g., R).
- Experience adhering to SOPs and regulatory guidelines.
- Excellent verbal and written communication; strong attention to detail and process orientation.
Compensation & Benefits:
- Anticipated salary range: $195,000–$215,000; annual bonus and equity participation.
- Benefits include medical/dental/vision insurance; life and long-/short-term disability; paid parental leave; 401K with match; unlimited vacation; tuition assistance; ESPP participation.
Application Instructions:
- Apply directly via the Career Center: https://www.stoketherapeutics.com/careers/