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Senior Statistical Programmer/Analyst, Oncology
ClinChoice. Lead statistical programming activities for oncology clinical studies from study start-up through database lock, analysis, and reporting .
About the role
Key responsibilities & impact- Lead statistical programming activities for oncology clinical studies from study start-up through database lock, analysis, and reporting
- Develop, review, and maintain SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs)
- Lead programming activities for interim and final analyses, including complex efficacy and safety analyses
- Work with Biostatisticians on statistical analysis plans, programming specifications, and study requirements
- Develop and review programming specifications consistent with study protocols, SAPs, and statistical methodology
- Support creation and validation of CDISC-compliant SDTM and ADaM datasets
- Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables
- Perform independent programming validation and quality control of statistical outputs and datasets
- Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams
- Identify programming issues and communicate risks, timelines, and solutions to project stakeholders
- Coordinate programming activities across studies and ensure timely, high-quality deliverables
- Provide technical guidance and mentorship to Statistical Programmers and other programming team members
- Participate in client/project meetings and communicate technical information to technical and non-technical stakeholders
Requirements
What you’ll need- Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
- Strong experience in clinical trial statistical programming, preferably within a CRO, pharmaceutical, or biotechnology environment
- Significant experience working on oncology clinical trials
- Experience supporting regulatory submissions
- Strong proficiency in SAS programming, including Base SAS and relevant SAS procedures used for clinical trial reporting
- Strong knowledge of CDISC standards, particularly SDTM and ADaM
- Experience developing and validating TLFs for clinical trials
- Experience working with complex clinical trial data and supporting statistical analyses
- Ability to independently manage programming deliverables and lead study-level programming activities
- Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports
- Excellent communication, organizational, problem-solving, and collaboration skills
- Basic or working knowledge of R programming is preferred
Benefits
Comp & perks- Security and additional career opportunities from working for a global CRO
- Professional development
- Supportive culture
- Continuous training
- Close management and training
- Equal opportunity employer with a focus on diversity and inclusivity