Sr SAS Programmer, HTA Submissions

We are seeking an experienced Senior Statistical Programmer with strong oncology and Health Technology Assessment (HTA) experience to support clinical development and evidence-generation activities. The ideal candidate will have a strong background in statistical programming, clinical trial data standards, and the development of analyses and outputs used to support HTA submissions, regulatory submissions, and payer/reimbursement decisions.

This individual will work closely with biostatisticians, HEOR/RWE teams, clinical development, and cross-functional stakeholders to deliver high-quality programming and analyses across oncology programs.

Key Responsibilities

• Lead and perform statistical programming activities supporting oncology clinical trials and HTA submissions.

• Develop, validate, and maintain analysis datasets and statistical outputs for clinical and health economics analyses.

• Program ADaM datasets, TLFs, and other analysis deliverables using SAS and/or R.

• Support analyses required for HTA submissions, including evidence packages for agencies and reimbursement bodies.

• Contribute to the development of analyses supporting comparative effectiveness, indirect treatment comparisons (ITCs), and network meta-analysis (NMA) deliverables.

• Support time-to-event, survival, efficacy, safety, and subgroup analyses within oncology studies.

• Work with biostatisticians and HEOR scientists to translate statistical analysis plans into high-quality programming specifications and outputs.

• Review programming specifications, analysis plans, shells, and validation documentation.

• Perform independent programming validation and QC of statistical outputs.

• Support responses to questions from regulatory agencies and HTA bodies.

• Ensure programming follows CDISC standards, company SOPs, and applicable regulatory requirements.

• Provide technical guidance and mentorship to other statistical programmers.

• Collaborate with global cross-functional teams to ensure timely delivery of submission-quality analyses.

Required Qualifications

• 8+ years of statistical programming experience within pharmaceutical, biotechnology, CRO, or related life sciences environments.

• Strong experience supporting oncology clinical trials, preferably across Phase II/III development programs.

• Hands-on experience with HTA submissions and/or health economics and outcomes research (HEOR) deliverables.

• Advanced programming experience with SAS and/or R.

• Strong knowledge of CDISC standards, including SDTM and ADaM.

• Extensive experience developing Tables, Listings, and Figures (TLFs).

• Strong understanding of clinical trial data and statistical methodology.

• Experience with efficacy, safety, subgroup, and time-to-event analyses.

• Experience working with global cross-functional teams and submission deliverables.

• Strong understanding of data validation, QC, and programming standards.

• Excellent communication, organization, and problem-solving skills.

Preferred Qualifications

• Experience supporting NICE, CADTH, G-BA, or other major HTA agencies.

• Experience with NMA/ITC, comparative effectiveness, or indirect treatment comparisons.

• Experience with real-world evidence (RWE) and/or observational datasets.

• Experience supporting global regulatory submissions.

• Oncology experience across solid tumors and/or hematologic malignancies.

• Experience with R-based programming and modern statistical programming workflows.

• Master’s degree or higher in Statistics, Biostatistics, Mathematics, Epidemiology, or a related quantitative discipline.