United States onlyAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking an experienced Principal Programmer, Statistical Programming (Contractor) to lead the development and validation of statistical programs for late-stage clinical studies. This role ensures programming activities are conducted in compliance with SOPs and regulatory requirements to produce high-quality, timely deliverables.
Essential Responsibilities:
- Develop and validate statistical programs to generate high-quality, on-time deliverables for both in-house and outsourced projects, in compliance with company SOPs and regulatory requirements.
- Perform analysis tasks to support clinical study reports (CSRs) and integrated summaries of safety and efficacy (ISS/ISE) for NDA submissions.
- Create and review programming plans and specifications for datasets and TLFs; apply advanced knowledge of CDISC standards, including SDTM and ADaM, and experience in implementing these models.
- Review biometrics documents such as SAPs, CRFs, data review plans, and data transfer agreements.
- Conduct data quality checks across raw data, SDTM, and ADaM datasets; identify root causes of data issues and propose solutions.
- Review and validate CRO deliverables, including SDTM, ADaM and TLFs; provide solutions to issues raised by CROs.
- Review eSubmission datasets and associated documentation (e.g., aCRF, reviewer guides, define.xml, and programs) to ensure compliance with submission requirements.
- Leverage expert-level SAS programming skills to develop macros supporting study and project activities, enhancing programming efficiency and capacity.
- Maintain familiarity with ICH guidelines and demonstrate advanced knowledge of regulatory submission requirements and standards
- Support the preparation of clinical study reports, regulatory submissions, and DSURs and annual safety reports across multiple studies.
- Communicate effectively within project teams, across departments, with functional partners, and with external collaborators.
- Perform other programming duties as assigned.
The Ideal Candidate:
- Expert-level SAS programmer with a track record of delivering complex programming assignments; proficient in developing and modifying code, including macros.
- Advanced knowledge and hands-on experience with CDISC standards (CDASH, SDTM, and ADaM).
- Experienced in the drug development process and in collaborating with CROs.
- Familiarity with regulatory submission processes to FDA, EMEA, and CDE filings.
- Strong interpersonal skills and effective verbal and written communication capabilities.
- Highly detail-oriented with strong consistency and quality standards.
Education:
Bachelor’s degree (or equivalent) in a computational or biological science with a minimum of 8 years of directly related experience in a drug development environment
or
Master’s degree with a minimum of 6 years of related experience.
This is a remote position based in South San Francisco, CA. While we prefer local candidates, remote applicants based across the continental United States will gladly be considered.
Alumis Inc. is an equal opportunity employer.
Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include:
- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.
