Manager, Statistical Programming

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $160k - $195k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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Rezolute, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $96.9M Post-IPO Equity - Rezolute on 2025-04

Healthcare • Biotechnology • Pharmaceuticals

Rezolute, Inc. is a biopharmaceutical company focused on developing and delivering novel therapies for rare metabolic disorders, specifically hyperinsulinism. The company’s lead program, ersodetug, has two Phase 3 programs targeting congenital and tumor hyperinsulinism, and Rezolute conducts clinical trials, investigator-initiated studies, and publishes clinical outcomes. Rezolute also engages with patients, investors, and the medical community to improve care and quality of life for affected patients and families.

📋 Description

• 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

• 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

• 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