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A highly productive, independent statistical data sciences lead ensuring excellence in the delivery of analysis ready datasets, analysis results, and displays such as tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes. Ensures adherence to high quality statistical data sciences principles, processes and techniques in the production of clinical reports. This role is the statistical data sciences point of contact at the study level, and will support at the asset/submission level.
Job Responsibility:
Ensuring excellence in the delivery of analysis ready datasets, analysis results, and displays such as tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes
Ensuring adherence to high quality statistical data sciences principles, processes and techniques in the production of clinical reports
Being the statistical data sciences point of contact at the study level, and supporting at the asset/submission level
Delivering through combination of oversight of in-house statistical data scientists / vendors / offshore support as well as through hands on application of statistical data sciences techniques
Working with department leadership and project teams to establish strategy, timelines, and resourcing of deliverables for their study(ies)
Being accountable for the quality and timely delivery of datasets, analysis results and displays required for their clinical study reports as well as other asset level deliverables
Ensuring appropriate documentation across the lifespan of the study for deliverables and verifying proper Trial Master File filings
Ensuring planning is in place for all deliverables including consideration of special data types and downstream uses of data
Working with statisticians, statistical data science resources and other colleagues to ensure clear specifications for deliverables are in place
Being knowledgeable in core safety standards as well as Therapeutic Area standards or Industry data standards for unique data types
Aiding in development of standards necessary for their study or asset
Contributing to department level initiatives
Being proactive at communicating potential issues to upper management
Anticipating and solving routine problems, while developing the ability to solve complex problems
Supervising and supporting a team, fostering collaboration and continuous improvement
Requirements:
Bachelor’s or Master’s (preferred) Degree in Statistics, Data Sciences, Biological Sciences, IT, or related field
At least 5 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
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 including submission requirements and data conformance (e.g., Pinnacle21)
Statistical Programming and SAS, R, or Python hands-on experience
Familiarity with R packages, Shiny Apps, Markdown reports and other associated data science and data analytics tools and AI/ML highly desired
Experience with Real World Evidence and other big data sources and associated standards (e.g.OMOP, JSON, ODHSI ) in support of regulatory filings desired
Active participation in relevant industry groups (e.g., PHUSE, CDISC, IHD)
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 (e.g., CDISC)
Extensive knowledge of routine statistical methodology and its application to statistical data sciences
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
Nice to have:
Familiarity with R packages, Shiny Apps, Markdown reports and other associated data science and data analytics tools and AI/ML
Experience with Real World Evidence and other big data sources and associated standards (e.g.OMOP, JSON, ODHSI ) in support of regulatory filings
Active participation in relevant industry groups (e.g., PHUSE, CDISC, IHD)
Some exposure working across international boundaries and cultures