Manager, Statistical Data Sciences Lead NEW

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Job Summary

• 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 Responsibilities

• Will deliver 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 (e.g., use of tools such as SAS, R, and Python to process clinical trial data and big data sources such as Real World Evidence to inform decision making).
• Works with department leadership and project teams to establish strategy, timelines, and resourcing of deliverables for their study(ies).
• 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 they may contribute to under the leadership of the asset lead.
• Ensures appropriate documentation across the lifespan of the study for deliverables and verifies proper Trial Master File filings when appropriate.
• Ensures planning is in place for all deliverables including consideration of special data types and downstream uses of data.
• Works with statisticians, statistical data science resources and other colleagues as appropriate to ensure clear specifications for deliverables are in place.
• Will be knowledgeable in core safety standards as well as Therapeutic Area standards or Industry data standards for unique data types pertinent to their project. May aid in development of standards necessary for their study or asset.
• 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.
• Supervises and supports a team, fostering collaboration and continuous improvement.
  

Qualifications / Skills

• 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.