Associate Director, RWE Statistics Programming

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.

Essential Functions Of The Job (Key Responsibilities)

• Conduct statistical programming of clinical data and real-world data (RWD) using SAS.

• Generate analysis datasets according to CDISC standards and the Statistical Analysis Plan (SAP) (including ADaM where applicable).

• Implement analysis methods per SAP and produce tables, listings, and figures (TLFs), summary tables, graphs, and data listings using SAS.

• Support Medical Affairs evidence generation by delivering analysis-ready datasets and publication-quality outputs for internal insights and external dissemination (e.g., abstracts, posters, manuscripts, presentations).

• Program and QC HTA-aligned analyses using clinical and RWD sources to support payer and reimbursement evidence needs, including alignment to PICO and specific HTA expectations.

• Produce traceable comparative evidence outputs (e.g., baseline characteristics, treatment patterns, outcomes, subgroup analyses) suitable for HTA evidence packages and to support health economic modeling inputs.

• Implement and document HTA-relevant analytic methods as appropriate (e.g., propensity score matching/weighting, balance diagnostics such as standardized mean differences, time-to-event and longitudinal outcome analyses) with clear validation/QC.

• Ensure programs, outputs, and documentation are consistent with ICH guidelines and conducted in compliance with company SOPs and applicable regulatory expectations (including electronic submission standards).

• Validate programs and associated results produced by other programmers; perform independent QC to ensure accuracy, reproducibility, and high-quality deliverables.

• Run and review CDISC validation programs (e.g., OpenCDISC-style reports) to ensure datasets are CDISC-compliant; resolve findings and ensure clean validation summaries.

• Participate in the review of SAPs and other documents essential to the conduct of statistical programming work.

• Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timeline and deliverable are met.

• Program and coordinate for individual projects and studies with minimum supervision.

• Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.

• Check that the validation summary reports are clean of errors and warnings and show proper documentation of SAS programs.

• Assist in the preparation of statistical reports, presentations, and publications, summarizing findings and providing insights to stakeholders.

• Conduct exploratory and ad hoc data analyses to identify trends, patterns, and associations in real-world data.

• Assess resource needs and to ensure projects are adequately resourced.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree (MS degree in statistics or computer sciences is desired) or relevant experience and equivalent qualifications will also be considered

• Minimum 8 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries

• Experience supporting studies and analyses across Oncology, Hematology, and Dermatology therapeutic areas

• Experience supporting Phase I–IV clinical trials, including statistical programming for study deliverables across early- and late-stage development

• Statistical Programmer with familiarity and hands-on experience working with Real-World Evidence (RWE) datasets, partnering closely with Medical Affairs teams to support evidence generation, analyses, and data-driven insights

• Data Management experience including CDISC standard is highly desirable

• Strong SAS programming skills and attention to detail are essential

• Demonstrate knowledge of regulatory guidelines, including electronic submission standards

• Strong organizational, time management, communication and project coordination and leadership skills

• Must be able to work well under timeline pressure

• Must be able to work on multiple tasks while coordinating others at the same time

• Demonstrate experience serving as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems