Head of Biostatistics & Innovative Trial Design

ABA Search, Inc.; South San Francisco (CA); Sur place; USD 230 000 - 300 000; Plein temps

Avantages offerts par ce poste

Bonus eligibility

Résumé du poste

ABA Search, Inc. seeks a Director of Biostatistics to lead statistical strategy across clinical programs in a research-driven biotech context in South San Francisco. You will drive trial design, regulatory interactions, and data-driven decisions shaping development plans.

Lead cross-functional teams, mentor statisticians, and manage external vendors while applying Bayesian and adaptive designs to complex data. A PhD or MS with extensive experience is required.

Qualifications

• Ph.D. in Biostatistics/Statistics or equivalent with 8+ years of relevant work experience, or M.S. with 10+ years of relevant experience.
• Broad and thorough understanding of statistical principles and clinical trial methodology.
• Experience with NDA or other major regulatory submissions.
• Experience managing CROs, external statistical consultants, and statistical programming vendors.
• Leadership skills in prioritization, adapting to change, conflict resolution, and partnership, with sound scientific judgment and the ability to work independently.
• Excellent written and verbal communication skills, including with non-statistical stakeholders.

Responsabilités

• Independently lead biostatistical support for assigned therapeutic programs and studies across development phases.
• Shape statistical strategy, development plans, protocols, endpoint selection, and sample size in line with regulatory requirements.
• Evaluate study design alternatives, risks, and uncertainties with clinical and scientific teams to support development decisions.
• Develop innovative trial designs, including adaptive, Bayesian, and simulation-based approaches.
• Apply statistical expertise to small, heterogeneous populations, rare diseases, and limited clinical data.
• Communicate statistical concepts, assumptions, and limitations clearly to cross-functional teams.

Connaissances

Biostatistics leadership

Clinical trial design

Regulatory submissions

CRO management

Statistical leadership

Formation

PhD in Biostatistics/Statistics or MS with extensive experience

Description du poste

ABA Search, Inc. seeks a Director of Biostatistics to lead statistical strategy across clinical programs in a research-driven biotech context in South San Francisco. You will drive trial design, regulatory interactions, and data-driven decisions shaping development plans.

Lead cross-functional teams, mentor statisticians, and manage external vendors while applying Bayesian and adaptive designs to complex data. A PhD or MS with extensive experience is required.