---
title: 'Manager, Statistical Programming at Rezolute'
canonical: 'https://feeny.ai/job/manager-statistical-programming-rezolute-remote-g58ra51zr042'
type: 'job'
last_seen: '2026-10-16'
---

# Manager, Statistical Programming at Rezolute

- **Company:** Rezolute
- **Location:** Remote
- **Employment:** full-time
- **Work type:** remote
- **Posted:** 2026-10-01
- **Last confirmed live:** 2026-10-16
- **Apply:** https://jobs.lever.co/rezolutebio/6189625d-ae5b-49f1-8004-c18577550419

## Job description

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity. Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders More information can be found at rezolutebio.com

Position Summary 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.

## Responsibilities

- 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.

## Qualifications

- 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.

Rezolute (RZLT) currently anticipates the base salary for the Manager of Statistical programming  role could range from $160,000 to $195,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

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

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

## About Rezolute

## Company Overview
- **One-liner**: Rezolute is a late-stage rare disease biotechnology company developing ersodetug, a monoclonal antibody therapy for hypoglycemia caused by congenital and tumor hyperinsulinism.
- **Entity Type**: Public (Nasdaq: RZLT)
- **Headquarters**: Redwood City, California, United States (with an additional office in Louisville)
- **Founded**: Not publicly available (IPO 2012)
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Biotechnology – rare disease therapeutics
- **Target customers**: B2B – healthcare providers, patients, and payers; focuses on addressing severe unmet medical needs in hyperinsulinism
- **Mission/purpose**: Significantly improve outcomes for individuals with hypoglycemia caused by hyperinsulinism ([rezolutebio.com – About](https://rezolutebio.com/job-openings/))

## Products & Services
- **Ersodetug (lead candidate)**: An intravenously administered human monoclonal antibody that allosterically binds to the insulin receptor, down‑modulating insulin action to restore normal glucose levels. Being developed for two indications:
  - **Congenital Hyperinsulinism (sunRIZE Phase 3 study)** – completed enrollment (May 2025) with 62 participants; topline results expected December 2025.
  - **Tumor Hyperinsulinism (upLIFT Phase 3 study)** – initiated mid‑2025; FDA agreed to a single‑arm open‑label design; topline results expected second half 2026.
  - Designations: Orphan Drug (US/EU), Rare Pediatric Disease, Breakthrough Therapy (US), PRIME (EU), ILAP (UK) ([ir.rezolutebio.com – 10-K](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf))

## Market Standing
- **Valuation/Market Cap**: $317.7 million (as of recent data, per LinkedIn) ([linkedin.com](https://linkedin.com/company/rezolute))
- **Key Metric (Public)**: Annual revenue of $14.1 million (likely from grants or collaboration revenue; no product revenue yet) ([linkedin.com](https://linkedin.com/company/rezolute))
- **Notable Investors/Partners**: Not publicly available – company is publicly traded and does not disclose a lead investor list. Key partners include clinical trial sites and regulatory agencies (FDA, EMA).
- **Growth Signals**:
  - Headcount: 50 employees (+2.9% YoY) ([linkedin.com](https://linkedin.com/company/rezolute))
  - Phase 3 sunRIZE study fully enrolled; topline data pending December 2025.
  - Phase 3 upLIFT study enrolling with streamlined design; data expected second half 2026.
  - FDA granted Breakthrough Therapy Designation for tumor HI in May 2025.
  - Multiple regulatory designations accelerating development pathway.

## Competitive Advantages
- **Unique mechanism**: Ersodetug acts downstream from beta cells at the insulin receptor, allowing it to potentially treat all forms of hyperinsulinism (genetic or acquired) regardless of underlying cause.
- **Dosing convenience**: Half‑life >2 weeks enables monthly intravenous administration.
- **Regulatory momentum**: Orphan Drug, Rare Pediatric Disease, Breakthrough Therapy, PRIME, and ILAP designations provide expedited review, potential priority review voucher, and closer FDA/EMA collaboration.
- **Pivotal data catalysts**: Two Phase 3 studies read out within ~12‑18 months, creating clear value inflection points.

## Strategic Focus
- Execute the two ongoing Phase 3 trials (sunRIZE in congenital HI, upLIFT in tumor HI).
- Assuming positive topline data from sunRIZE, submit a Biologics License Application (BLA) to the FDA for ersodetug in mid‑2026.
- Continue to build commercial and medical affairs infrastructure (recent job postings indicate hires in Commercial Operations, Marketing, Payer Strategy, and Supply Chain) ([rezolutebio.com – Job Openings](https://rezolutebio.com/job-openings/)).

## Why Work Here
- **Mission‑driven**: Employees work on therapies for ultra‑rare, life‑threatening conditions with high unmet medical need.
- **Benefits**: Comprehensive health/dental/vision insurance, competitive salaries, annual bonus, 401(k) with company match, tuition assistance, on‑site meals, flexible spending accounts ([rezolutebio.com – Benefits](https://rezolutebio.com/job-openings/)).
- **Work environment**: Hybrid/office policy not explicitly stated; roles are based in Redwood City (HQ) and Louisville. Recent openings include remote-friendly functions? Not confirmed.
- **Growth opportunity**: Small company (~50 people) entering late‑stage development and pre‑commercial build‑out – employees can have broad impact and career advancement.
- **Engineering culture**: For biotech, the focus is on clinical operations, regulatory, and commercial roles rather than traditional engineering. IT positions (Business System Engineer) exist.

## Sources
1. [linkedin.com – Rezolute company page](https://linkedin.com/company/rezolute)
2. [rezolutebio.com – Job Openings & Benefits](https://rezolutebio.com/job-openings/)
3. [ir.rezolutebio.com – SEC 10-K Filing (September 2025)](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf)
4. [rezolutebio.com – Leadership page](https://rezolutebio.com/leadership/)

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