We are seeking an experienced Senior Programmer with a strong oncology and Health Technology Assessment (HTA) background to support clinical development and evidence-generation activities. This hands‑on, technically driven role works closely with biostatisticians, HEOR and RWE teams, and clinical development stakeholders to deliver high-quality programming and analyses across oncology programs — from Phase II/III clinical trials through HTA and payer submissions.
Key responsibilities
- Lead and perform statistical programming activities supporting oncology clinical trials and HTA submissions
- Develop, validate, and maintain ADaM datasets, TLFs, and other analysis deliverables using SAS and/or R
- 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
- Ensure all programming follows CDISC standards, applicable SOPs, and regulatory requirements
HTA & HEOR support
- Support analyses required for HTA submissions including evidence packages for payer and reimbursement bodies
- Contribute to comparative effectiveness analyses, indirect treatment comparisons (ITCs), and network meta‑analysis (NMA) deliverables
- Support responses to questions from regulatory agencies and HTA bodies
QC, validation & documentation
- Perform independent programming validation and QC of statistical outputs
- Review programming specifications, analysis plans, shells, and validation documentation
- Ensure deliverables meet submission‑quality standards across clinical and health economics programs
Collaboration & leadership
- Provide technical guidance and mentorship to other statistical programmers
- Collaborate with global cross‑functional teams to ensure timely delivery of high‑quality analyses
Required qualifications
Experience
- 8+ years of statistical programming experience in pharma, biotech, CRO, or related life sciences environments
- Strong experience supporting oncology clinical trials, preferably across Phase II/III programs
- Hands‑on experience with HTA submissions and/or HEOR programming deliverables
- Extensive experience developing ADaM datasets and TLFs
- Experience with efficacy, safety, subgroup, and time‑to‑event analyses
- Experience working with global cross‑functional teams on submission deliverables
Technical skills
- Advanced programming experience in SAS and/or R
- Strong knowledge of CDISC standards including SDTM and ADaM
- Strong understanding of clinical trial data, statistical methodology, and programming QC standards
- Excellent communication, organizational, and problem‑solving skills