Pfizer Statistical Programming Group Lead (Director) in Groton, Connecticut
This role will have full accountability for all the programming deliverables for the assets in the Global Brands portfolio.
This role will have direct management responsibilities.
Ensures excellence in the delivery of analysis ready datasets, tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes at the asset level.
Ensures adherence to high quality programming standards in the production of clinical reports and submission documentation at the asset level.
Will contribute to and lead departmental initiatives as needed.
Will have people management responsibilities (6-10 FTEs)
Works with department leadership to help establish strategy for the programming discipline.
Works with their programming leads to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within the Global Brands portfolio.
Accountable for the quality and timely delivery of datasets and displays required for clinical study reports, submissions, product defense and commercial support based on analysis plans through leadership, and guidance of internal and external resources.
Responsible for planning all programmed deliverables including consideration of special data types and downstream uses of data as well as contributing to the asset level/submission strategy.
Works with other leads across statistics, clinical, regulatory and other colleagues as appropriate to ensure proper prioritization and communication.
Will contribute to, and lead department level initiatives. Will also contribute to broader initiatives outside of the department.
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
At least 10 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
Statistical Programming and SAS hands-on experience
Clinical trials expertise with a thorough understanding of the drug development process and data operations required for the reporting of clinical trial data (e.g. study reports, regulatory submissions, safety updates, etc.)
Adept at solving problems using skills based on experience and extrapolation to new situations.
Expert knowledge of clinical data, regulatory requirements, and relevant data standards
Knowledge of vendor processes and best practices in outsourcing and oversight
Experience in leading a programming team for necessary deliverables at the asset level within a matrixed organization
Demonstrated experience managing complex projects and developing successful partnerships within study and asset teams
Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills
Proven ability to operate independently in ambiguous situations
Sound knowledge and experience working across international boundaries and cultures.
Ability to manage customer expectations, anticipate potential objections, and influence others
CDISC experience highly desirable.
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