Associate Clinical Statistical Programmer - ACSP24-13272

Job Title: Associate Clinical Statistical Programmer

Location: 100% Remote (East Coast preferred, occasional site visits every 3 months)

Job Overview:

The Outcomes Research Stats Analyst/Statistical Programmer will report to the Director of Data Analytics or Medical Affairs Outcomes Research. The role focuses on Women’s Health, Established Brands, Biosimilars, and in-licensing opportunities. You will be responsible for the internal analysis of research programs, designing and delivering internal research projects, and providing insights across the portfolio. This includes observational studies for developmental and commercialized products. The findings will support internal stakeholders, congress submissions, and manuscript development.

Key Responsibilities:

• Deliver internal data analysis of studies involving observational research for developmental and commercialized products.
• Communicate findings to internal stakeholders and support research projects for congress presentations and manuscript submissions.
• Develop protocols and Statistical Analysis Plans (SAP) based on study concepts, ensuring the appropriateness of study design, sample size, and statistical methodologies.
• Implement rigorous quality control processes and programming templates to ensure data and analysis integrity.
• Conduct statistical analyses to generate tables, listings, and figures for publications and internal presentations.
• Meet project timelines with minimal supervision, demonstrating excellent verbal and written communication skills.
• Translate statistical information effectively for various audiences.

Education:

• Minimum: Master’s degree in Health Economics, Biostatistics, Health Services Research, Public Health, Epidemiology, Pharmacy Administration, or related field with experience in coding and statistical analysis.
• Advanced degree (PhD, DrPH, PharmD) is a plus.
• Must have publications listed on resume.

Required Experience and Skills:

• Minimum 3 years of SAS programming experience.
• At least 2 years of hands-on experience with real-world studies using large claims/EMR databases in Health Economics and Outcomes Research (HEOR).
• Strong programming skills in SAS and R programming, with data analysis expertise.
• Extensive experience working with large U.S. insurance claims databases, EMR, and health outcomes research (e.g., Optum, Premier, Marketscan, Humedica, etc.).
• Familiarity with cloud and high-performance computing environments (Azure, AWS).
• Experience with medical and billing coding systems such as ICD-10, SNOMED, LOINC, NDC, HCPCS, and CPT.
• Experience with Ex-US healthcare databases such as the THIN database is a plus.
• Experience working in the pharmaceutical industry, with expertise in claims or EMR databases for research purposes.

Technical Requirements:

• Required Software:
  • SAS (minimum requirement)
• Nice to Have Software:
  • R Shiny
  • Python

Preferred Experience:

• Competitive analysis with other drug products.
• Expertise in real-world data, U.S. insurance claims databases, and outcome research methodologies (e.g., score matching, regression).
• Familiarity with post-marketing, preclinical, and Phase 4 or later research stages.
• Knowledge of AWS systems and market landscape analysis.

Notes:

• Candidates should have experience working directly with Outcomes Research groups on retrospective studies, from protocol development through SAS programming, analysis, and publishable results.
• Prior experience in pharma (e.g., GSK, AstraZeneca) is a plus.

What We Are Not Looking For:

• Oracle experience
• GCP/ICH experience
• Clinical research experience (not relevant for this role)