Senior Biostatistics Director: Strategy & Regulatory

Generate Biomedicines; Somerville (MA); Sur place; USD 219 000 - 300 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Equity compensation

Benefits package

Résumé du poste

Generate Biomedicines seeks a Senior Director of Biostatistics to lead statistical strategy across late-stage programs, regulatory readiness, and collaborations with Clinical Development and Regulatory Affairs. This role combines strategic leadership with hands-on ownership of critical statistical deliverables to drive rigorous trial execution and informed decision-making.

The ideal candidate will have a PhD or MS in Biostatistics, 12+ years (PhD) or 15+ years (MS) in biotech/pharma, and a

Qualifications

• PhD or MS in Biostatistics with extensive biotech/pharma experience.
• Proven leadership of biostatistics teams on late-stage programs.
• Experience with regulatory submissions and agency interactions.

Responsabilités

• Lead statistical strategy for late-stage programs and regulatory readiness.
• Draft/review SAPs and statistical components of protocols and submissions.
• Mentor and develop a high-impact biostatistics team.
• Collaborate with cross-functional teams to ensure rigorous trial execution.

Connaissances

Biostatistics leadership

Respiratory disease experience

Asthma Phase 3 trials

Adaptive/Bayesian designs

Regulatory interactions

R and SAS proficiency

Mentoring/people management

Statistical strategy

Formation

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Outils

R

SAS

Description du poste

Generate Biomedicines seeks a Senior Director of Biostatistics to lead statistical strategy across late-stage programs, regulatory readiness, and collaborations with Clinical Development and Regulatory Affairs. This role combines strategic leadership with hands-on ownership of critical statistical deliverables to drive rigorous trial execution and informed decision-making.

The ideal candidate will have a PhD or MS in Biostatistics, 12+ years (PhD) or 15+ years (MS) in biotech/pharma, and a