- 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
- 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 complex programming issues using problem solving skills and previous experience
- Will contribute to, and may lead department level initiatives. May also contribute to broader initiatives outside of the department.
- Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
- At least 8 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.
- Understanding of clinical data and relevant data standards
- Thorough knowledge of ICH guidelines and regulatory requirements
- Knowledge of vendor processes and best practices in outsourcing and oversight
- Experience in leading a remote programming team for necessary deliverables
- 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
- Proven ability to present technical information to a non-technical audience
- Sound knowledge and experience working across international boundaries and cultures.
- Ability to manage customer expectations, anticipate potential objections, and influence others
- Extensive knowledge of statistical methodology and its application to programming
- CDISC experience highly desirable.
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