Senior Biostatistics Director
2 weeks ago
ROLE SUMMARY
- Design, develop, and implement statistical strategies for clinical trials and observational studies in compliance with regulatory requirements, Pfizer standards, and best practices.
- Provide scientifically rigorous statistical expertise on projects and protocols in support of clinical development, regulatory submissions, and evidence generation efforts for Pfizer products.
- Collaborate with cross-functional teams to provide study and project level statistical counsel and communicate resource needs.
KEY RESPONSIBILITIES
- Develop and execute statistical analysis plans, interpret and communicate statistical results, and provide project development plans.
- Lead the planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, and support for publication activities.
- Ensure timeliness and quality of study/submission level statistical deliverables on assigned projects.
- Foster effective collaborations internally and externally, including clinical teams, regulatory, payer, industry, professional, and academic organizations.
- Maintain compliance with all required training and regulatory requirements.
- Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or regulatory and HTA submissions.
- Collaborate with Statistics Program Lead and/or Statistics Therapeutic Area Head to plan support for assigned projects, studies, and submissions.
- Comply with all statistics and quality processes, Pfizer data standards, and support processes that require statistical input.
- Present a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
- Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs.
QUALIFICATIONS
- Advanced degree in statistics, biostatistics, or related field.
- A minimum of 4 years' experience in the clinical trial setting, preferably in oncology or pharma.
- Relevant clinical trial, real-world data, 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 level.
- Strong statistical skills with application to clinical trials, especially survival analysis methodology.
- Effective verbal and written communication skills.
This role requires 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.
Pfizer offers a comprehensive and generous benefits package, including 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).
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