Director, Biostatistics

Pfizer

ROLE SUMMARY:
The Director, Oncology Biometrics is a seasoned technical statistical contributor to complex programs. The person in this role:
• Specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions within Pfizer's Oncology Biometrics.
• Provides statistical and strategic inputs to clinical development planning.
• Contributes to departmental or cross-functional initiatives to enhance business processes and improve efficiency.
• Possesses the ability to plan, direct, coordinate and execute a variety of specialized and complex global development projects.
• Has knowledge of clinical design of experiments, clinical data management and programming tools, and ability to interpret results from clinical studies.
• Has the ability to help implement new initiatives and assist in strategic planning.
• Keeps current on new developments and technological advancements in statistics.
• Is highly motivated.
• Possesses excellent written and verbal communication skills.
• Can effectively collaborate with different functional groups.

ROLE RESPONSIBILITIES:
• Serve as a study statistician for assigned clinical studies related to one or more clinical programs and may serve as a program statistical lead.
• Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality and in a timely manner.
• Provide statistical and strategic input on clinical development plans.
• Contribute to the development of clinical study protocols and author the statistical sections.
• Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials.
• Develop IRC/DMC charter as needed.
• Develop study randomization specification and verification documents as necessary.
• Perform sample size calculations and assess trial design operating characteristics under a variety of assumptions and propose the most efficient design that will address study objectives.
• Review CRFs and edit checks and participate in UAT of different systems (e.g. randomization).
• Review dataset programming specifications and key derived variables.
• Independently derive and verify key efficacy endpoints and analyses developed by programming.
• Perform or oversee the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations.
• Provide statistical leadership in clinical study team and global development team, as appropriate.
• Independently present at department, project team, or Sr. Management meetings.
• Lead inter-department projects involving other contributors.
• Represent Pfizer Biostatistics when interacting with regulatory agencies.
• Provide mentorship to other biostatisticians.
• Review the work of other biostatisticians as appropriate.

BASIC QUALIFICATIONS:
• Demonstrated high aptitude (considered a subject matter expert internally) in key areas of responsibility, which is typically associated with a Ph.D. degree in statistics, biostatistics, or a related field with 8+ years of experience, or a master's degree in statistics, biostatistics, or a related field with 10+ years of experience in clinical trials.
• High aptitude in:
• FDA/EMA and other regulations
• ICH GCP guidelines
• Drug development process
• CDISC standards and implementation guides
• Statistical methods and applications to clinical trial design and data analysis
• Programming skills in R and/or SAS
• Company SOPs and business practices
• Previous experience in:
• Oncology clinical trials
• Submission experience
• Statistical research and simulation experience
• Demonstrated ability to:
• Develop and deliver multi-mode efficient communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences.
• Lead and manage multiple projects.
• Take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
• Consistently achieve results, even under tough circumstances.
• Adapt approach and demeanor in real time to match the shifting demands of different situations.
• Build partnerships and work collaboratively with others to meet shared objectives.
• Make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
• Plan and prioritize work to meet commitments aligned with organizational goals.

PREFERRED QUALIIFICATIONS
• Experience with innovative trial designs

ORGANIZATIONAL RELATIONSHIPS
• Internally, interact with Clinical, Regulatory, Operation, Data Management, Programming, HEOR, Clinical Pharmacology, Translational Oncology and others, as needed.
• Externally, interact with counterparts at dif

Location: San Francisco, CA

Posted: Aug. 20, 2024, 8:53 a.m.