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# Manager, Statistical Programming

- **Company:** Rezolute, Inc.
- **Location:** United States (Remote available)
- **Experience:** Starter
- **Salary:** $160,000.0 - $195,000.0
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Clinical Data Management, Clinical Data Repository, Computer Programming, Programming Tools, R (Programming Language), Python (Programming Language), SAS (Software), SQL Databases, Visual Analytics, Extensible Markup Language (XML), Data Processing, Information Technology, Statistics Packages, Data Management
- **Published:** October 3, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=1e52cf944162f2ff

## About the Role

* BS/BA in Statistics, Computer Science, Mathematics, Life Sciences, or a related field; MS preferred.
 * 8+ years of statistical programming experience in pharma, biotech, or CRO with a BS, or 6+ years with an MS.
 * 1-2 years of experience supervising programmers or serving as lead programmer on a study.
 * Strong SAS skills (Base, Macro, SQL, STAT, ODS/Graph).
 * Working proficiency in R for clinical data manipulation, analysis, and reporting (e.g., tidyverse, admiral, gt, rtables, or similar).
 * Experience developing R Shiny applications for interactive data review, safety monitoring, or visualization of clinical trial data is a plus.
 * Working knowledge of CDISC SDTM and ADaM, controlled terminology, and Define-XML.
 * Familiarity with ICH guidelines and GCP; exposure to a regulatory submission is a plus.
 * Experience with Python for automation, data processing, or tooling is a plus.
 * Clear written and verbal communication; comfortable working directly with statisticians and clinical teams.

## Description

The Manager of Statistical Programming is responsible for delivering study-level programming deliverables and milestones. The role combines hands-on programming in SAS and R with oversight of a small team or of CRO programmers assigned to a study., The position requires working knowledge of statistical programming languages and software, clinical trial data, and the drug development process. The incumbent develops and oversees programs that generate CDISC-compliant SDTM and ADaM datasets, TLFs, and reports supporting the review of clinical data. The incumbent also writes validation programs and general-purpose code, prepares documentation to support electronic submissions, and contributes to programming standards and templates., * Plans and delivers statistical programming for assigned studies in support of clinical trials, regulatory submissions, publications, and ad hoc analysis requests, following applicable regulatory guidelines and standards.

 * Tracks programming timelines for assigned studies and flags risks to the Director so deliverables stay aligned with the study schedule.
 * Creates or oversees the creation of CDISC-compliant SDTM and ADaM datasets, and performs conformance checks (e.g., Pinnacle 21) before delivery.
 * Develops and validates TLFs and analysis datasets using SAS and R; performs independent QC of programming produced by others, including cross-language validation where appropriate.
 * Assigns and reviews the work of a small team of internal programmers and/or CRO programmers; provides day-to-day direction, feedback, and mentoring.
 * Reviews CRO deliverables, specifications, and documentation for quality and standards compliance, and escalates issues as needed.
 * Participates in study meetings with Clinical Operations, Data Management, Safety, and Biostatistics to develop specifications and reports.
 * Writes and maintains batch scripts to schedule SAS and R jobs and distribute reports to the clinical team.
 * Prepares programming documentation supporting electronic submissions, including define.xml inputs and reviewer guide content.
 * Contributes to the development of SAS macros, R functions, standards, templates, and SOPs, and to cross-functional initiatives.
 * Provides input on programming tools and infrastructure needs, including SAS and R environments, and works with IT as needed.