Job Summary

Job Description

Responsibilities

• Lead and execute statistical programming activities by developing and validating datasets and Tables, Listings, and Figures (TLFs) to ensure high-quality deliverables for pivotal studies, as well as Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) for oncology regulatory submissions.
• Drive end-to-end programming from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements.
• Responsibilities include developing SDTM CRF annotations and SDTM specifications, as well as analysis dataset specifications to ensure accurate implementation of SAPs and TLF shells; performing hands-on programming to create and validate SDTM and ADaM datasets and TLFs, ensuring quality, integrity, and submission readiness; and ensuring datasets meet CDISC and regulatory submission standards while conducting comprehensive reviews of submission data packages to ensure quality, completeness, and alignment with regulatory expectations.
• Manage and coordinate statistical programming activities for project planning and delivery to ensure high-quality outputs and adherence to timelines.
• Responsibilities include developing and managing programming timelines and resource plans; collaborating closely with Biostatistics, Data Management, and cross-functional teams to ensure efficient and accurate execution; managing the generation and tracking of datasets and TLFs for ongoing and completed studies; ensuring appropriate data usage and high-quality outputs; proactively identifying and resolving programming-related issues prior to database lock and analysis; ensuring the completeness and accuracy of all study programming deliverables; and maintaining all required programming documentation in compliance with Trial Master File (TMF) requirements.
• For outsourced studies, oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.
• Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF).
• Maintain institutional knowledge across oncology compounds and support the development of standardized programming practices for datasets and TLFs to improve efficiency and quality.
• Responsibilities include contributing to CRF and SDTM standard development; supporting the development, implementation, and maintenance of Analysis Data Model (ADaM) datasets and TLF standards; and supporting training initiatives to ensure consistent implementation of ADaM and TLF standards in clinical trial analyses.
• Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies.
• Responsibilities include developing TLFs to support submission-related QAs with quick turnaround timelines; supporting ad hoc and exploratory analyses requested by clinical teams; and providing programming support for regulatory responses and potential Advisory Committee meetings.
• Develop and maintain programming macros to effectively support internal data review and monitoring.
• Responsibilities include collaborating with Biostatistics team members to define requirements for efficacy data review; developing and enhancing macros; and supporting the internal data review and monitoring activities.

Qualifications

Education Qualifications

• Master's Degree Biostatistics or similar degree required
• PhD Biostatistics or similar degree preferred 

Experience Qualifications

• 6+ years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a master’s degree required
• Oncology experience required
• Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred
• Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred
• Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. preferred
• Knowledge of all phases of drug development, including early and late phase clinical development and global submission preferred

Travel Requirements

• Ability to travel up to 10% of the time.