Alumis hiring Contract, Principal Programmer, Statistical Programming • Remote (Work from Home) | Himalayas
AlumisAL

Contract, Principal Programmer, Statistical Programming

Alumis Inc. is a clinical-stage biopharmaceutical company developing targeted oral therapies for immune-mediated diseases using a precision medicine approach. Their lead candidate, ESK-001, is a TYK2 inhibitor for plaque psoriasis and systemic lupus erythematosus.

Alumis

Employee count: 51-200

United States only

Alumis 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.

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Job type

Full Time

Experience level

Senior
Executive

Location requirements

Hiring timezones

United States +/- 0 hours

About Alumis

Learn more about Alumis and their company culture.

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Alumis Inc. is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients with immune-mediated diseases. The company focuses on a precision medicine approach, aiming to replace broad immunosuppression with targeted oral therapies. Alumis leverages its proprietary precision data analytics platform, which integrates genetic, genomic, proteomic, and clinical data, to identify optimal targets, molecules, and treatment combinations. This data-driven strategy is designed to select the right target, right molecule, right indication, right patient, and right endpoint, thereby optimizing therapeutic outcomes. Incubated by Foresite Labs, Alumis is led by an experienced team with a strong track record in precision medicine drug discovery, development, and immunology.

The company's pipeline includes next-generation treatments designed to address significant unmet needs in various autoimmune disorders. Alumis' most advanced product candidate, ESK-001, is an oral, highly selective, allosteric inhibitor of tyrosine kinase 2 (TYK2). ESK-001 has demonstrated promising results in a Phase 2 clinical trial for patients with moderate-to-severe plaque psoriasis (PsO) and is also being evaluated in a Phase 2 trial for systemic lupus erythematosus (SLE). Alumis is also developing A-005, a CNS-penetrant allosteric TYK2 inhibitor intended for neuroinflammatory and neurodegenerative diseases. The company's name, Alumis, is derived from 'allumer' (French for illuminate) and 'immunis' (Latin for the immune system), reflecting its mission to enlighten immunology. Recently, Alumis completed a merger with ACELYRIN, Inc., a move expected to strengthen its financial position and advance its late-stage pipeline. The combined entity will continue to operate under the Alumis name, with headquarters in South San Francisco, California.

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