Pfizer Senior Director BioStatistics in Groton, Connecticut
Group Lead will manage 3-7 colleagues and contractors as well as oversee work from other statisticians in the organization. Will be responsible for statistical oversight of multiple projects in one or more therapeutic areas (Oncology, Rare Disease, Internal Medicine, Immunology & Inflammation).
The Group Lead will play a leadership role in ensuring excellent statistical input into the design and development of project plans and regulatory strategies; the planning & delivery of statistical analyses, data presentations, and scientific reports for clinical trial and regulatory submission; product defense and, market support and for scientific presentations/publications; and analyses establishing value and supporting market access in conformance with good statistical practices and with the FDA and ICH guidelines. The Group Lead will further develop his/her group's statistics capabilities to support design, analysis, reporting and Scientific and commercialization activities using leading edge statistical applied research methodologies.
Ensure high value statistical deliverables in all projects in the disease area through effective supervision of staff and through own individual contributions
Ensure that all statistical work in the assigned disease area is done to the appropriate level of quality and statistical rigor
Provide strategic, technical, and administrative oversight of statistical function in his/her group, as assigned
Ensure that all activities in assigned group are conducted in compliance with relevant regulatory requirements, SOPs and applicable guidelines
Monitor and report on implementation of Global statistical initiatives in his/her group
Develop clinical statisticians, including recruitment, retention, and career development
Implement strategies to ensure that the statisticians are collaborative, strategic partners with scientific and clinical colleagues, including Global Health and Value.
Develops effective collaborations with other disease area group leads; and with other GPD functional lines, and with external regulatory, industry, professional and academic organizations
Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice; and encourage/sponsor research in statistical methodology and its applications pertinent to Pfizer business needs
Implement strategies to ensure speed and quality, fully integrated global data analyses on individual studies and for submissions.
Implement aligned strategies and consistent processes to optimize the use of corporate standards
Provide project-level leadership as appropriate.
The qualified candidate must have a M.S. or Ph.D. in Statistics, Biostatistics, or related field, as well as a minimum of ten years experience in applying statistics in a pharmaceutical or related industry.
The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in innovative methods including computational simulation and Bayesian statistics.
The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.
Strong communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are required.
Relevant clinical trial and business experience providing a superior understanding of the processes associated with clinical, regulatory and marketing operations.
Experience managing and developing statisticians.
This role can be located at any of the listed locations.
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EEO & Employment Eligibility
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