Pfizer Statistical Programming Lead (Manager) in Groton, Connecticut
A highly productive, independent programming lead ensuring 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
This role is the programming point of contact at the study level, and will support at the asset/submission level.
Ensures adherence to high quality programming standards in the production of clinical reports.
Will deliver through combination of oversight of vendors/offshore support as well as through hands on programming
Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables for their study(ies).
Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may contribute to under the leadership of the asset lead. Ensures appropriate documentation across the lifespan of the study for all programming deliverables and verifies proper Trial Master File filings when appropriate.
Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data
Works with statisticians, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place.
Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to their project, may aid in development of standards necessary for their study
Will contribute to department level initiatives.
Proactive at communicating potential issues to upper management
Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
At least 5 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 data operations required for the reporting of clinical trial data.
Good understanding of ICH and Regulatory Guidelines
Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.
Thorough understanding of clinical data and relevant data standards
Extensive knowledge of routine statistical methodology and its application to programming
Knowledge of vendor processes
Demonstrated experience in developing successful partnerships within study teams
Strong written and oral communication skills, and project management skills
Ability to present technical information to a non-technical audience
Proven ability to operate independently.
Some exposure working across international boundaries and cultures.
Ability to manage customer expectations.
Ability to manage work of others in a remote and/or global setting
CDISC experience highly desirable.
EEO & Employment Eligibility
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