Manager, Statistical Programming

Rezolute, Inc.

. Plan and deliver statistical programming for assigned studies supporting clinical trials, regulatory submissions, publications, and ad hoc analysis requests.

Posted 10/2/2026full-timeRemote • United StatesSeniorLead💰 $160,000 - $195,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical programming for clinical trials, including proficiency in SAS and R, with a strong focus on CDISC compliance and quality control. Capable of leading programming teams, mentoring staff, and ensuring adherence to regulatory standards.

Highest-signal resume keywords

SAS ProgrammingR ProgrammingCDISC SDTM/ADaM ComplianceStatistical Programming LeadershipQuality Control in Programming

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingSAS BaseSAS MacroSAS SQLSAS STATSAS ODS/GraphR for Data ManipulationR Shiny DevelopmentPython for AutomationBatch Scripting

Soft Skills

Clear CommunicationMentoringTeam Collaboration

Tools & Technologies

Pinnacle 21Define-XMLTidyverseAdmiralGCP Compliance

Industry Keywords

Clinical TrialsRegulatory SubmissionsBiotechPharmaCRO

Tech Stack

Tools & technologies

Google Cloud PlatformPythonSQL

About the role

Key responsibilities & impact

Plan and deliver statistical programming for assigned studies supporting clinical trials, regulatory submissions, publications, and ad hoc analysis requests.
Track programming timelines and flag risks to the Director.
Create or oversee CDISC-compliant SDTM and ADaM datasets and perform conformance checks using tools such as Pinnacle 21.
Develop and validate TLFs and analysis datasets using SAS and R.
Perform independent quality control of programming produced by others, including cross-language validation where appropriate.
Assign and review work of internal and CRO programmers; provide direction, feedback, and mentoring.
Review CRO deliverables, specifications, and documentation for quality and standards compliance.
Participate in study meetings with Clinical Operations, Data Management, Safety, and Biostatistics.
Write and maintain batch scripts to schedule SAS and R jobs and distribute reports.
Prepare programming documentation supporting electronic submissions, including define.xml inputs and reviewer guide content.
Contribute to SAS macros, R functions, standards, templates, SOPs, and cross-functional initiatives.
Provide input on programming tools and infrastructure needs and work with IT as needed.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Annual performance bonus
Health Insurance (Medical / Dental / Vision)
Disability, Life & Long-Term Care Insurance
Holiday Pay
Tracking Free Vacation Program
401(k) Plan Match
Educational Assistance Benefit
Fitness Center Reimbursement