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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 Responsibility:
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
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
Requirements:
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
Demonstrated high aptitude in FDA/EMA and other regulations
Demonstrated high aptitude in ICH GCP guidelines
Demonstrated high aptitude in Drug development process
Demonstrated high aptitude in CDISC standards and implementation guides
Demonstrated high aptitude in Statistical methods and applications to clinical trial design and data analysis
Demonstrated high aptitude in Programming skills in R and/or SAS
Demonstrated high aptitude in Company SOPs and business practices
Demonstrated ability to develop and deliver multi-mode communications
Demonstrated ability to manage multiple projects
Demonstrated ability to take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
Demonstrated ability to consistently achieve results, even under tough circumstances
Demonstrated ability to adapt approach and demeanor in real time to match the shifting demands of different situations
Demonstrated ability to build partnerships and work collaboratively with others to meet shared objectives
Demonstrated ability to make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems
Demonstrated ability to plan and prioritize work to meet commitments aligned with organizational goals
Nice to have:
Oncology experience
Strong statistical research and simulation skills and experience
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
What we offer:
Participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary
Eligibility to participate in our share based long term incentive program
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
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility