Director Biostatistics

Proclinical is seeking a Director Biostatistics to join a clinical-stage pharmaceutical company located in San Francisco, CA.

The individual in the role of Biostatistics Director will collaborate with diverse teams in various functions, contributing to the planning, analysis, and documentation of clinical studies. This includes offering statistical expertise and advocating for regulatory submissions, as well as aligning with the company's external publications and overall corporate objectives.

Must be eligible to work in the US.

Job Responsibilities:

• Crafting statistical sections within protocols, authoring Statistical Analysis Plans (SAPs), and contributing to the efficacy results sections of Clinical Study Reports (CSRs).
• Steering the design and execution of clinical studies by overseeing the development of statistical sections in study protocols and statistical analysis plans.
• Providing statistical support and analyses for regulatory interactions, submissions, and the defense of regulatory matters.
• Demonstrating familiarity with study details and analyses, preparing responses to regulatory inquiries, and actively participating in regulatory defense and inspection activities.
• Offering statistical insights for the interpretation and discussion of results in CSRs, Investigator's Brochures (IB), Integrated Summaries of Efficacy (ISE), publications, and strategic business decisions.
• Collaborating with vendor Contract Research Organizations (CROs) to ensure timely and high-quality deliverables, including analysis plans and outputs for individual studies and pooled analyses.
• Engaging with statistical programming to clarify analysis dataset specifications, documentations, and the review of derived variables, along with contributing to the quality control plan.
• Providing statistical consultation to cross-functional groups.
• Contributing to Case Report Form (CRF) and database design, particularly focusing on efficacy data collection and validation, study design, protocol development, sample size estimation, formulation of statistical hypotheses, testing strategy, and statistical methods.
• Sustaining statistical expertise by staying abreast of new methodologies, selecting appropriate methods for analysis, and justifying the chosen methods.
• Supervising statistical contractors/consultants and providing guidance to junior team members.

Skills and Requirements:

• A PhD in Statistics with 8 years of experience in clinical development within the pharmaceutical, biotechnology, or CRO industry, or an MS in Statistics with 10 years of experience.
• Strong verbal and written communication skills, with the ability to collaborate effectively in a team environment with medical professionals, clinical monitors, programmers, data managers, and medical writers. Attention to detail is essential.
• Knowledge of FDA/ICH guidelines. Experience with preparing New Drug Applications (NDAs), briefing documents, and responses to regulatory questions is required, and Advisory Committee experience is desirable.
• Extensive knowledge and superior understanding of advanced statistical concepts and techniques.
• Capability to manage multiple priorities and navigate ambiguity swiftly.
• Proficiency in the use of statistical software (e.g., SAS, R, JMP) and in sample size estimation.
• Providing input for the planning and management of external budgets related to statistical deliverables.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or m.hermiz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.