Manager, Biostatistics

About the Role

This position will provide statistical support for projects in the Inflammation and Immunology disease area in Global Product Development. The qualified candidate will collaborate and work closely with project or study teams and provide statistical expertise in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful candidates will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies.

Key Responsibilities

• Provide statistical input into project development plans, study design, and statistical analysis plans.
• Be accountable for quality statistical deliverables according to study timelines.
• Ensure that all study and project-level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
• Provide data presentation plans and interpretation of statistical analysis results and contribute to clinical trial reports.
• Provide support for publications and scientific presentations of study results.
• Provide input to the Statistics Group Lead to plan support for assigned studies and submissions.
• Communicate and collaborate with other project statisticians to ensure consistency of statistical approaches across studies.
• Participate in research on statistical methodology and its applications pertinent to the business needs of the organization.

Requirements & Tech Stack

• SAS or R programming languages
• Understanding of broad statistical theory and its application
• Effective verbal and written communication skills
• Effectively and clearly explaining statistical concepts to colleagues without statistical training
• Work collaboratively as a team member

Qualifications

• MS in Statistics/Biostatistics or related field with 4+ years’ experience OR PhD in Statistics/Biostatistics or related field with 0+ years of experience

Preferred Qualifications

• Strong computational skills
• Experience with different study designs, protocol development, and statistical analysis plan writing
• Experience with statistical modeling of clinical data and statistical inference

Organizational Relationships

As a key member of a project team, this position will interact directly with:

• Clinical (Clinicians)
• Clinical Pharmacology
• Statistical Programming
• Data Management
• Regulatory Strategy and Operations
• Medical
• Outcomes Research
• Commercial
• Operations
• Contract organizations supporting project deliverables

Work Location Assignment: On Premise