Director of Biostatistics

Penfield Search Partners Ltd; South San Francisco (CA); Sur place; USD 235 000 - 300 000; Plein temps

Résumé du poste

Penfield Search Partners Ltd in the United States seeks an Associate Director or Director of Biostatistics to provide statistical leadership for clinical programs, directing data analyses, study design considerations, and regulatory submission strategies.

The role requires PhD or MS in Biostatistics with 8+ or 10+ years’ experience, leadership of CROs and external vendors, and onsite work at least four days a week; base salary ranges from $235,000 to $300,000 with annual bonuses.

Qualifications

• PhD or MS in Biostatistics/Statistics with extensive relevant experience.
• Experience leading statistical teams and external partners.
• Proven ability to influence study design and regulatory strategies.

Responsabilités

• Independently lead biostatistical support for therapeutic programs and studies.
• Develop statistical strategies aligned with development objectives and regulatory requirements.
• Collaborate with cross-functional teams to evaluate design options and risks.
• Provide input on protocols, endpoint selection, and sample size considerations.
• Develop adaptive designs, Bayesian methods, and simulations as appropriate.
• Communicate statistical concepts clearly to non-statistical stakeholders.

Connaissances

Leadership

CRO management

Regulatory submissions

Communication

Independent work

Formation

PhD in Biostatistics

MS in Biostatistics

Outils

SAS

R

Simulation

Description du poste

Job Description: The Associate Director or Director of Biostatistics will be responsible for providing statistical data analysis expertise and leadership to support assigned clinical programs. They provide a scientifically stimulating and collaborative working environment, and this role will interact with scientists from a range of disciplines including basic research, computational biology, pharmacology, PKPD and biomarker experts. We are seeking a creative and innovative statistical scientist to direct project teams towards efficient strategies for data integration across multiple platforms with the ultimate goal of deriving meaningful inferences about the human condition.

Key Responsibilities:

• Independently lead biostatistical support for assigned therapeutic programs and clinical studies across development phases
• Develop statistical strategies aligned with clinical development objectives and regulatory requirements
• Collaborate with clinical and scientific teams to evaluate study design alternatives, assess risks and uncertainties, and support data-driven development decisions
• Provide statistical input into clinical development plans, study protocols, endpoint selection, sample size considerations, and overall evidence-generation strategies
• Develop and evaluate innovative trial designs, including adaptive designs, Bayesian approaches, and simulation-based methods, as appropriate
• Provide statistical expertise for studies involving small sample sizes, heterogeneous patient populations, rare diseases, and limited clinical data
• Communicate statistical concepts, assumptions, limitations, and implications clearly to cross-functional teams

Position Requirements:

• Ph.D. in Biostatistics/Statistics or equivalent with at least 8+ years’ relevant work experiences or M.S. in Biostatistics/Statistics with at least 10+ years’ relevant experience
• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• Leadership skills in priority evaluation, adapting to changes, conflict resolution, and effective partnership
• Ability to work independently, exercise sound scientific judgment, and manage multiple competing priorities
• Experience managing CROs, external statistical consultants, and statistical programming vendors
• Experience with NDA or other major regulatory submissions
• Excellent written and verbal communication skills, including the ability to communicate statistical concepts to non-statistical stakeholders
• Experience supporting rare disease or other indications with small patient populations and limited clinical data is preferred
• Experience with external control groups, natural history studies, patient registries, or systematic literature reviews is preferred
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $235,000 - $300,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.