Associate Director, RWE Statistics Programming
Incyte
July 01, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Job Summary (Primary Function)
The Associate Director, RWE Statistics Programming is responsible for statistical programming that processes clinical trial and real-world data required for statistical analysis of Phase I–IV clinical trials, observational studies, and Medical Affairs real-world evidence (RWE) research/evidence generation activities. Ensures efficiency, timeliness, quality, and traceability of deliverables, including outputs supporting scientific communications and HTA/payer-relevant evidence.
Key Responsibilities (Essential Functions)
- Conduct statistical programming of clinical data and real-world data (RWD) using SAS.
- Create analysis datasets per CDISC standards and the Statistical Analysis Plan (SAP), including ADaM where applicable.
- Implement SAP analysis methods and produce TLFs, summary tables, graphs, and data listings using SAS.
- Perform exploratory and ad hoc analyses to identify trends and associations in RWE/RWD.
- Support Medical Affairs evidence generation (analysis-ready datasets and publication-quality outputs: abstracts, posters, manuscripts, presentations).
- Program and QC HTA-aligned analyses to support payer/reimbursement evidence (PICO/HTA expectations).
- Produce traceable comparative evidence outputs (baseline characteristics, treatment patterns, outcomes, subgroup analyses) for HTA evidence packages and health economic modeling inputs.
- Implement/document HTA-analytic methods (e.g., propensity score matching/weighting, balance diagnostics, time-to-event/longitudinal analyses) with validation/QC.
- Ensure compliance with ICH guidelines, company SOPs, and regulatory/electronic submission standards.
- Validate other programmers’ work and perform independent QC; run/review CDISC validation (e.g., OpenCDISC-style reports).
- Participate in SAP/document reviews; coordinate with CROs as needed.
- Work independently; manage storage of completed programming outputs; verify clean validation summaries.
- Assist with statistical reports, presentations, and publications; assess resource needs.
Qualifications
- BA/BS (MS in statistics or computer sciences desired) or equivalent experience.
- Minimum 8 years SAS/Base/Macro/GRAPH programming experience in biopharma and/or CRO.
- Experience supporting Oncology, Hematology, and Dermatology.
- Phase I–IV clinical trial programming experience across early/late development.
- Hands-on RWE dataset experience; partner with Medical Affairs for evidence generation.
- Data Management experience including CDISC is highly desirable.
- Strong SAS skills/attention to detail; knowledge of regulatory guidelines and electronic submission standards.
- Strong organization, time management, communication, coordination, and leadership.
- Able to work under timeline pressure; multitask while coordinating others.
- Experience mentoring junior programmers and advising on complex problems.
The Associate Director, RWE Statistics Programming is responsible for statistical programming that processes clinical trial and real-world data required for statistical analysis of Phase I–IV clinical trials, observational studies, and Medical Affairs real-world evidence (RWE) research/evidence generation activities. Ensures efficiency, timeliness, quality, and traceability of deliverables, including outputs supporting scientific communications and HTA/payer-relevant evidence.
Key Responsibilities (Essential Functions)
- Conduct statistical programming of clinical data and real-world data (RWD) using SAS.
- Create analysis datasets per CDISC standards and the Statistical Analysis Plan (SAP), including ADaM where applicable.
- Implement SAP analysis methods and produce TLFs, summary tables, graphs, and data listings using SAS.
- Perform exploratory and ad hoc analyses to identify trends and associations in RWE/RWD.
- Support Medical Affairs evidence generation (analysis-ready datasets and publication-quality outputs: abstracts, posters, manuscripts, presentations).
- Program and QC HTA-aligned analyses to support payer/reimbursement evidence (PICO/HTA expectations).
- Produce traceable comparative evidence outputs (baseline characteristics, treatment patterns, outcomes, subgroup analyses) for HTA evidence packages and health economic modeling inputs.
- Implement/document HTA-analytic methods (e.g., propensity score matching/weighting, balance diagnostics, time-to-event/longitudinal analyses) with validation/QC.
- Ensure compliance with ICH guidelines, company SOPs, and regulatory/electronic submission standards.
- Validate other programmers’ work and perform independent QC; run/review CDISC validation (e.g., OpenCDISC-style reports).
- Participate in SAP/document reviews; coordinate with CROs as needed.
- Work independently; manage storage of completed programming outputs; verify clean validation summaries.
- Assist with statistical reports, presentations, and publications; assess resource needs.
Qualifications
- BA/BS (MS in statistics or computer sciences desired) or equivalent experience.
- Minimum 8 years SAS/Base/Macro/GRAPH programming experience in biopharma and/or CRO.
- Experience supporting Oncology, Hematology, and Dermatology.
- Phase I–IV clinical trial programming experience across early/late development.
- Hands-on RWE dataset experience; partner with Medical Affairs for evidence generation.
- Data Management experience including CDISC is highly desirable.
- Strong SAS skills/attention to detail; knowledge of regulatory guidelines and electronic submission standards.
- Strong organization, time management, communication, coordination, and leadership.
- Able to work under timeline pressure; multitask while coordinating others.
- Experience mentoring junior programmers and advising on complex problems.