Senior Statistical Analyst

Connect Life Sciences

United States

On-site

USD 120,000 - 180,000

Full time

5 days ago
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Job summary

Connect Life Sciences is seeking an experienced Senior Programmer with a strong oncology and HTA background to support clinical development and evidence-generation activities. You will work closely with biostatisticians, HEOR and RWE teams, and clinical development stakeholders to deliver high-quality programming across oncology programs—from Phase II/III trials through HTA and payer submissions.

You will lead programming activities, develop ADaM datasets and TLFs using SAS and/or R, and ensure

Qualifications

  • 8+ years of statistical programming experience in pharma, biotech, CRO, or related life sciences environments.
  • 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.

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.
  • Collaborate with biostatisticians and HEOR scientists to translate SAPs into programming outputs.
  • Ensure all programming follows CDISC standards, SOPs, and regulatory requirements.

Skills

Statistical programming
Oncology trials
HTA/HEOR
CDISC standards
ADaM datasets
SAS
R
QC & validation

Tools

SAS
R

Job description

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
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