Director, Biostatistics

JOB SUMMARY The Director will plan, direct, and coordinate specialized and complex global development projects within the Inflammation and Immunology & Specialty Care disease area at Pfizer Research and Development. The candidate’s accountabilities include overseeing clinical design, trial conduct, data management, result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and assisting in strategic planning.

The position may require managing contract biostatisticians, including resource allocation, work assignment scheduling, and project status monitoring to ensure timely project completion. Staying informed on advancements in statistics and maintaining strong collaboration with various functional groups are essential. Excellent communication skills, proficiency in statistical programming languages (R, SAS, or Python) and high motivation are crucial for success in this role.

JOB RESPONSIBILITIES
• Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects.
• Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results, exploratory analyses and analyses that synthesize results across studies, support for publication activities, scientific presentations and support for product defense.
• Be accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
• Develop effective collaborations with colleagues within clinical teams, partner lines of other functioning areas, and external regulatory, industry and professional and academic organizations.
• Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, alliance partner colleagues – for assigned studies and regulatory submissions.
• Provide input to the Statistics Group Lead (Senior Director or Executive Director) to plan support for assigned studies and submissions.
• Participate in research on innovative statistical methodology and its applications pertinent to Pfizer’s business needs.

QUALIFICATIONS / SKILLS
• 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 providing an understanding of the processes associated with clinical, regulatory and marketing operations.
• Capability to provide statistical leadership to cross-functional teams at the protocol and project level.
• Strong statistical skills with application to clinical trials.
• Effective verbal and written communication skills in collaborating with colleagues and associates both inside and outside the organization.
• 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 statistical programming languages (R, SAS, or Python) and experience with at least one reproducible research tool (e.g., R Markdown, Quarto, Git/Git Hub).PREFERRED QUALIFICATIONS
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve…