Manager, Statistical Programming

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.

Rezolutes 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

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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 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.
• 12 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 $160000 to $195000 and will depend in part on the successful candidates 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 Companys 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Manager