Company Name:-
Pfizer

Job Location:-
Connecticut

Job Summary:-
Job detailsJob TypeFull-timeFull Job DescriptionROLE SUMMARY
This role is the programming point of contact at the asset, indication, or study level.

Could have responsibility for multiple indications or studies depending on size
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.

In addition to management of the deliverables, the senior lead will also provide consultation to the asset/submission teams with respect to planning of programmed asset deliverables as well as standards strategy
Ensures adherence to high quality programming standards in the production of clinical reports and submission documentation
RESPONSIBILITIES:
May have people management responsibilities
Will be a mentor to more junior colleagues
Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within their area.

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 management of internal resource or oversight of external resources.

Ensures appropriate documentation across the lifespan of the study and asset 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 serve on a data standards board, and most likely will be leading implementation and potentially development of standards in their project area.

Responsible for managing issues at the study level as they arise and proactively communicating larger asset or general programming issues to management while serving to provide solutions.

Provides solutions to

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