Manager, Biostatistics

Job Summary
The Manager, Biostatistics is a biostatistician who can work with minimal supervision on statistical aspects associated with clinical trials. The person in this role:
• Is an individual contributor who can create clinical study designs, perform data analysis, provide data interpretation, and contribute to clinical publications.
• Provides statistical input to clinical development planning.
• Contributes to departmental or cross-functional initiatives to enhance business processes and improve efficiency.
Job Responsibilities
• Under supervision by senior statistician, serve as a study statistician for clinical studies related to one or more clinical programs.
• Work with senior level statistician to provide statistically sound experimental design and data analysis strategies to meet project objectives and regulatory requirements with high quality in a timely manner.
• 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.
• 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 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.
• Participate in the development and maintenance of department tools, templates, and guidelines.
• Contribute to department initiatives and promote best practices.
• May independently present at department or project team meetings.
Qualifications/Skills
MINIMUM QUALIIFICATIONS
• Demonstrated proficiency (teaches others, makes improvements) in key areas of responsibility, which is typically associated with a master's degree in Statistics or Biostatistics with minimum 2 years of experience in an applied statistics setting, or a Ph.D. in Statistics, Biostatistics, or a comparable quantitative field.
• Ability to learn/gain working knowledge of:
• FDA/EMA or other regulations
• ICH GCP guidelines
• Drug development process
• CDISC standards and implementation guides
• Company SOPs and business practices
• Proficient in:
• Statistical methods and applications to clinical trial design and data analysis
• Programming skills in R and/or SAS
• 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.
• 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.
PREFERRED QUALIIFICATIONS
• Clinical trial experience.
• Statistical research and simulation skills.
• Strong written and verbal communication skills
• Demonstrated ability to work effectively as a part of an interdisciplinary team
Work Location Assignment: Hybrid, must be onsite an average of 2.5 days per week.
The annual base salary for this position ranges from $106,000.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% 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
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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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