Senior Manager, Statistical Programming

Job Description

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 Senior Manager, Statistical Programming to drive the development and validation of statistical programs for late-stage clinical studies. In this role, you will ensure programming activities align with SOPs and regulatory requirements, delivering high-quality and timely results. This is an exciting opportunity to contribute to critical drug development efforts while driving efficiency and compliance in statistical programming.

RESPONSIBILITIES

• Lead the development and validation of statistical programs to ensure high-quality deliverables for both in-house and outsourced projects, adhering to company and regulatory requirements.
• Drive ISS / ISE analysis tasks in support of NDA submissions.
• Assist in planning and coordinating project work to ensure timely and high-quality delivery across multiple studies.
• Develop and review programming plans, dataset specifications, and TLFs; apply expertise in CDISC standards, including SDTM and ADaM models.
• Review documents produced by biometric functions such as SAPs, CRFs, data review plans, and data transfer agreements.
• Oversee CRO programming activities, reviewing and validating CRO deliverables including SDTM, ADaM and TLFs, while providing solutions to any issues raised by CROs.
• Review eSubmission datasets and data documentation such as aCRF, reviewer guides, define documents and programs to ensure all files meet submission requirements.
• Develop macros to support study and project activities, contributing to global macro tools that enhance the overall efficiency and capacity of the programming function.
• Maintain deep familiarity with ICH guidelines and advanced knowledge of regulatory submission requirements, ensuring all statistical programming deliverables meet industry and company standards.
• Support the preparation of clinical study reports, regulatory submissions, DSURs, and safety reports across multiple studies.
• Contribute to the development, implementation and continuous improvement of programming processes and standards.
• Communicate effectively within project teams, across departments, and with external collaborators.

THE IDEAL CANDIDATE

EDUCATION

This position is located in South San Francisco, CA. At this time we are not considering remote applicants.

The salary range for this position is $180,000 - $210,00 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

Alumis Inc. is an equal opportunity employer.