Associate Director, Biostatistics

JOB SUMMARY
The Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role:

• Is an individual contributor role who specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions.
• Provides statistical input to study designs and can contribute to departmental or cross-functional initiatives to enhance business processes and improve efficiency.

JOB RESPONSIBILITIES
• Serve as a study statistician for assigned clinical studies related to one or more clinical programs.
• Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner.
• Provide statistical inputs 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 or ad-hoc analyses.
• Develop study randomization specification and verification documents as necessary.
• Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives.
• Review CRFs and edit checks and participate in UAT of different systems.
• Review dataset programming specifications, key derived variables, and statistical deliverables.
• Independently derive from source data key efficacy variables and analyses.
• Perform 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.
• Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner.
• Provide statistical leadership in clinical study team setting.
• May independently present at department, project team, or Sr. Management meetings.
• May lead inter-department projects involving other contributors.
MINIMUM QUALIFICATIONS
• Demonstrated high aptitude (considered a subject matter expert internally) in key areas of responsibility , which is typically associated with a Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a master's degree in Statistics, Biostatistics or related field with 7+ 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
• Demonstrated ability to:
• Develop and deliver multi-mode communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences.
• 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
• Oncology experience
• Strong statistical research and simulation skills and experience
• 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 meaningful outcomes and create business impact.
Work Location Assignment: Hybrid, must be onsite an average of 2.5 days per week
The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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