Biostatistical Programming Manager

About the role

Drive Case Report Form design and data collection strategy within the Clinical Study Team to influence it for purpose data collection decisions while ensuring successful analysis and submission; Review Study Data Tabulation Model (SDTM) datasets and related specification and submission documents for analysis and regulatory submissions; Provide Clinical Data Interchange Standards Consortium expertise and guidance to the Clinical Study Team including the Global Statistical Programming team and cross functional partners for implementation and mapping; Author and review Study Data Tabulation Model submission files; Review Study Data Tabulation Model data conformance checks output and study team dispositions on selected snapshots as determined by need and perform Study Data Tabulation Model audit for all pivotal snapshots; Support global standards level content management and impact analysis; and Support cross-functional development of global standard, Therapeutic Area, and product-level Case Report Forms. May telecommute.

Requirements

Master's degree (or foreign equivalent) in Applied Science, Mathematics, or a related field & completion of a university-level course, research project, internship, or one year of experience in the following:

• Creating and managing annotated Case Report Forms (CRFs), reviewer's guides, and conformance documentation using controlled terminology and CDISC SDTM implementation guides
• Applying project management principles to coordinate timelines, deliverables related to applications that promote automation and harmonization of SDTM production across the portfolio, and cross-functional dependencies to ensure timely report completion
• Collaborating with external stakeholders, including Functional Service Providers (FSPs), Contract Research Organizations (CROs), or contingent workers to deliver study-level programming outputs including SDTM domains, CSDRG, Define.xml, and aCRF
• Working with clinical trial datasets to support regulatory submissions and internal analysis across different phases of clinical studies
• Preparing submission-ready datasets and documentation following CDISC and regulatory standards, including data mapping and ad hoc analyses
• Programming in statistical languages, including SAS, R, and Python, to develop and validate clinical data outputs
• Designing and programmatically developing automation tools for process improvement related to automation and harmonization of SDTM production across the portfolio

Pay

The annual salary for this position in the U.S. is $133,952.00–$192,690.00 per year.

Benefits

• Stock
• Retirement
• Medical, life and disability insurance
• Eligibility for an annual bonus or for sales roles, other incentive compensation