---
title: 'Director – Biostatistics at Rezolute'
canonical: 'https://feeny.ai/job/director-biostatistics-rezolute-redwood-city-rsdg74z82vkk'
type: 'job'
last_seen: '2026-11-06'
---

# Director – Biostatistics at Rezolute

- **Company:** Rezolute
- **Location:** Redwood City, CA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-11-03
- **Last confirmed live:** 2026-11-06
- **Apply:** https://jobs.lever.co/rezolutebio/41465a3e-c07a-40e5-978d-ebd0acf06e7c

## 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 lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity.

Position Summary

We are seeking an accomplished Director, Biostatistics to provide strategic and operational leadership for the statistical function within a growing, late-stage biopharmaceutical company. The organization currently has two Phase III clinical programs advancing toward regulatory submissions and commercialization, creating an exciting opportunity for a highly experienced statistician to influence development strategy, regulatory interactions, and submission readiness.

The Director, Biostatistics will serve as the lead statistical expert across clinical development programs, partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Statistical Programming, and external vendors. This individual will ensure the design, analysis, interpretation, and reporting of clinical trial data meet the highest scientific and regulatory standards.

Experience in rare disease drug development and NDA/BLA submissions is strongly preferred.

## Key Responsibilities

Statistical Leadership

- Provide strategic statistical oversight for Phase III clinical development programs and future lifecycle management activities.
- Lead the development of statistical strategies supporting clinical development plans, regulatory submissions, and post-hoc analyses.
- Serve as the statistical lead for one or more products and represent Biostatistics on cross-functional program teams.
- Advise senior management regarding statistical considerations, development risks, and mitigation strategies.

Clinical Trial Design & Analysis

- Lead the design and statistical methodology for Phase II, Phase III, and long-term extension studies.
- Author and review statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), and submission documents.
- Ensure high-quality analysis of efficacy, safety, patient-reported outcomes, and biomarker data.
- Oversee endpoint selection, estimands, multiplicity strategies, interim analyses, and adaptive design considerations where appropriate.

Regulatory & Submission Support

- Lead the statistical components of NDA/BLA/MAA submissions, including integrated efficacy and safety analyses, statistical documentation, responses to agency questions, and preparation for regulatory review and inspection.
- Represent and defend statistical positions in  interactions with global regulatory agencies, including FDA, EMA, MHRA, PMDA, and other health authorities.
- Support preparation of briefing packages, meeting materials, and responses to regulatory questions.
- Provide statistical leadership for NDA/BLA/MAA submission activities and inspection readiness.
- Ensure compliance with ICH, FDA, EMA, and other relevant regulatory guidance.

Vendor & Functional Oversight

- Manage and provide scientific and operational oversight of CROs, external biostatistics consultants, and statistical programming vendors.
- Collaborate closely with Statistical Programming to ensure analysis datasets, TLFs, and submission deliverables are generated according to CDISC standards.
- Review and approve key statistical deliverables to ensure quality, timelines, and regulatory compliance.

Cross-Functional Collaboration

- Partner with Clinical Development physicians, Clinical Operations, Data Management, Safety, and Regulatory Affairs to support program objectives.
- Present statistical findings to senior leadership, advisory boards, investigators, and external stakeholders.
- Mentor and develop junior statisticians and contribute to the growth of the Biometrics organization.

## Qualifications

Education

- Ph.D. in Statistics, Biostatistics, Mathematics, or related quantitative discipline preferred.
- Master's degree with significant industry experience will be considered.

## Experience

- 10+ years of biostatistical experience within the pharmaceutical, biotechnology, or CRO industry.
- Experience serving as lead statistician for late-stage clinical development programs.
- Demonstrated involvement in Phase III clinical trials and regulatory submissions.
- Experience supporting FDA and/or EMA interactions.
- Rare disease development experience strongly preferred.
- Prior experience in a small or emerging biotechnology environment is highly desirable.

Technical Skills

- Strong comprehensive knowledge of clinical trial methodology, statistical theory, and regulatory requirements.
- Expertise in ICH E9, estimands framework, adaptive trial designs, longitudinal data analysis, multiplicity methodologies, and missing data strategies.
- Working knowledge of CDISC SDTM and ADaM standards.
- Familiarity with SAS and R programming environments.
- Experience reviewing outputs, analyses, and submission deliverables generated by statistical programming teams.

Leadership Competencies

- Strategic thinker capable of balancing scientific rigor with business objectives.
- Strong communication and influencing skills across technical and non-technical stakeholders.
- Comfortable operating in a fast-paced, resource-conscious biotechnology environment.
- Demonstrated ability to manage multiple priorities while meeting aggressive development timelines.
- Collaborative, hands-on leader willing to work at both strategic and operational levels.

## Preferred Experience

- Rare disease, orphan drug, or ultra-rare disease development programs, analysis of continuous glucose monitoring in applicable therapeutic areas.
- Experience supporting NDA, BLA, or MAA submissions.
- Exposure to accelerated approval pathways or breakthrough designation programs.
- Experience in a company transitioning from late-stage development to commercialization.
- Prior leadership of biometrics vendors and global development programs.

Rezolute (RZLT) currently anticipates the base salary for the Director of Biostatistics role could range from $240,000 to $310,000 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/)

## Other roles at Rezolute

- [Medical Science Liaison / Senior Medical Science Liaison - Oncology / Rare Endocrine Disorders](https://feeny.ai/job/medical-science-liaison-senior-medical-science-liaison-oncology-rare-endocrine-bhs2782j7gtm)
- [Medical Science Liaison / Senior Medical Science Liaison - Pediatric Endocrinology / Rare Metabolic Disorders](https://feeny.ai/job/medical-science-liaison-senior-medical-science-liaison-pediatric-endocrinology-pvkvqb4szfae)
- [Recruiting Coordinator & Scheduler – 6 month contract](https://feeny.ai/job/recruiting-coordinator-scheduler-6-month-contract-rezolute-redwood-city-x0gcanx9q7vf) — Redwood City, CA
- [Contract Recruiter (Biopharmaceutical Industry) 6 month contract](https://feeny.ai/job/contract-recruiter-biopharmaceutical-industry-6-month-contract-rezolute-redwood-jvpc3bn5g8t2) — Redwood City, CA
- [Senior Manager, Scientific Communications & Medical Education](https://feeny.ai/job/senior-manager-scientific-communications-medical-education-rezolute-redwood-city-363wemxkxap1) — Redwood City, CA
- [Head of Product Launch Program Management (Rare Disease)](https://feeny.ai/job/head-of-product-launch-program-management-rare-disease-rezolute-redwood-city-7qka6sahvk1h) — Redwood City, CA
- [Associate Director, Medical Affairs Operations](https://feeny.ai/job/associate-director-medical-affairs-operations-rezolute-redwood-city-gg2p7j75sszn) — Redwood City, CA
- [Vice President, Global Manufacturing](https://feeny.ai/job/vice-president-global-manufacturing-rezolute-redwood-city-wcyqhfyet1yw) — Redwood City, CA
- [Vice President, Global Supply Chain](https://feeny.ai/job/vice-president-global-supply-chain-rezolute-redwood-city-q0dngx787mdk) — Redwood City, CA
- [Medical Writer II, Clinical/Regulatory](https://feeny.ai/job/medical-writer-ii-clinical-regulatory-rezolute-redwood-city-h43j74mshd1b) — Redwood City, CA