Director, Biostatistics in Cambridge

• Plan, direct, and coordinate specialized and complex global development projects in Inflammation and Immunology & Specialty Care




• Oversee clinical design, trial conduct, data management, result interpretation, and statistical support for global regulatory submissions




• Implement new initiatives and assist in strategic planning




• Manage contract biostatisticians when required, including resource allocation, work assignment scheduling, and project status monitoring




• Provide statistical input to study design, statistical analysis plans, result interpretation, development plans, regulatory issues, and registration projects




• Plan and communicate statistical analyses, data presentations, scientific reports, clinical trial results, exploratory analyses, and cross-study analyses




• Support publication activities, scientific presentations, and product defense




• Ensure timely and high-quality statistical deliverables and compliance with regulatory requirements and Pfizer standards




• Collaborate with clinical teams, partner functions, statisticians, study managers, alliance partners, regulators, industry, professional and academic organizations




• Provide statistical leadership to cross-functional activities and assigned studies and regulatory submissions




• Participate in research on innovative statistical methodology relevant to Pfizer’s business needs




• Interact with Clinical, Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and Operations, Medical, Outcomes Research, Commercial, Operations, and contract organizations

Requirements

• Masters in Statistics/Biostatistics (or related field) with extensive experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with notable experience in clinical trials




• Relevant clinical trial and business experience understanding clinical, regulatory and marketing operations




• Capability to provide statistical leadership to cross-functional teams at protocol and project level




• Strong statistical skills applied to clinical trials




• Effective verbal and written communication skills




• Experience providing statistical support and oversight for one or more clinical projects




• Ability to perform mathematical and statistical calculations




• Ability to perform complex data analysis




• Proficiency in R, SAS, or Python




• Experience with at least one reproducible research tool, such as R Markdown, Quarto, or Git/GitHub




• All applicants must have relevant authorisation to live and work in the UK

Core Competencies

Demonstrates expertise in statistical leadership for clinical trials, with proficiency in R, SAS, or Python, and a strong understanding of regulatory requirements. Capable of managing complex data analyses and providing strategic input for global development projects in Inflammation and Immunology.

Highest-signal resume keywords

• Masters In Statistics/Biostatistics




• PhD In Statistics/Biostatistics




• Statistical Leadership




• Proficiency In R, SAS, Or Python




• Clinical Trial Experience

ATS Optimization Keywords

Hard Skills

• Statistical Analysis




• Data Management




• Complex Data Analysis




• Mathematical Calculations




• Statistical Support




• Statistical Design




• Regulatory Submissions




• Result Interpretation




• Exploratory Analyses




• Cross-Study Analyses

Soft Skills

• Effective Communication

Industry Keywords

• Clinical Trials




• Inflammation




• Immunology




• Regulatory Compliance




• Biostatistics

Tools & Technologies

• R Markdown




• Quarto




• Git/GitHub