Note: The job is a remote job and is open to candidates in USA. Connect Life Sciences is seeking an experienced Senior Statistical Analyst to support oncology clinical development and evidence-generation activities. The role leads statistical programming, HTA and HEOR analyses, validation, documentation, and collaboration across clinical trials and payer submissions.
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
- 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
- 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
- Provide technical guidance and mentorship to other statistical programmers
- Collaborate with global cross-functional teams to ensure timely delivery of high-quality analyses
Skills
- 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
- 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
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