Contract, Principal Programmer, Statistical Programming
Location: South San Francisco
Posted on: June 23, 2025
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Job Description:
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.
Keywords: , Palo Alto , Contract, Principal Programmer, Statistical Programming, Science, Research & Development , South San Francisco, California
