Associate Clinical Statistical Programmer - ACSP24-13272

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

Job Overview:

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)