Senior Statistical Programmer/Analyst, Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee statistical programming functions for oncology clinical studies from initiation through database lock, analysis, and reporting.

• Create, review, and maintain SAS programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs).

• Direct programming efforts for interim and final analyses, encompassing intricate efficacy and safety evaluations.

• Collaborate with Biostatisticians to formulate statistical analysis plans, programming specifications, and study requirements.

• Develop and review programming specifications that align with study protocols, SAPs, and statistical methodologies.

• Assist in the creation and validation of CDISC-compliant SDTM and ADaM datasets.

• Produce and validate TLFs for clinical study reports, regulatory submissions, and other clinical outputs.

• Conduct independent programming validation and quality control of statistical outputs and datasets.

• Aid submission-related tasks and address programming and data inquiries from cross-functional and regulatory teams.

• Detect programming issues and relay risks, timelines, and solutions to project stakeholders.

• Manage programming activities across studies to ensure timely delivery of high-quality outputs.

• Offer technical guidance and mentorship to Statistical Programmers and other members of the programming team.

• Engage in client/project meetings and convey technical information to both technical and non-technical stakeholders.

⛳️ Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline.

• Extensive experience in statistical programming for clinical trials, ideally within a CRO, pharmaceutical, or biotechnology setting.

• Considerable experience in oncology clinical trials.

• Experience in supporting regulatory submissions.

• Strong expertise in SAS programming, including Base SAS and relevant SAS procedures for clinical trial reporting.

• Thorough understanding of CDISC standards, particularly SDTM and ADaM.

• Experience in developing and validating TLFs for clinical trials.

• Experience with complex clinical trial data and supporting statistical analyses.

• Capability to independently manage programming outputs and lead study-level programming efforts.

• Solid understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports.

• Exceptional communication, organizational, problem-solving, and collaborative skills.

• Basic or working knowledge of R programming is preferred.

🏝️ Benefits

• Job security and additional career opportunities within a global CRO.

• Opportunities for professional development.

• A supportive work culture.

• Continuous training provided.

• Close management and training available.

• An equal opportunity employer committed to diversity and inclusivity.