Alumis · 4 hours ago
Senior Manager, Statistical Programming
South San Francisco, CA
Full-time
Onsite
Senior Level
6+ years expAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. They are seeking an experienced Senior Manager, Statistical Programming to drive the development and validation of statistical programs for late-stage clinical studies, ensuring programming activities align with SOPs and regulatory requirements.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
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
Qualification
Required
Expert-level SAS programmer with a proven track-record of delivering complex programming assignments and analyses
Skilled in writing original code, developing macros and modifying existing code
Experience in developing and implementing statistical programming standards and procedures
Expert level knowledge and extensive hands-on experience with CDISC standards including CDASH, SDTM, and ADaM
Experience leading teams supporting FDA, EMEA, and CDE regulatory filings
Strong interpersonal skills with excellent written and verbal communication
Meticulous attention to detail and consistency
Bachelor's degree (or equivalent), preferably in a computational or biological science, with a minimum of 8 years of direct experience in drug development
Master's degree with minimum of 6 years of related experience
Company
Alumis
Alumis is a precision medicine company focused on the discovery, development and treatment of autoimmune disorders.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$917.19MKey Investors
Foresite CapitalMatrix Capital Management
2026-01-07Post Ipo Equity· $345.1M
2025-11-19Post Ipo Secondary· $3.09M
2024-07-23Post Ipo Equity· $40M
Leadership Team
Martin Babler
Chairman, President and CEO
K
Ken A Brameld
Fellow, Head of Discovery
Recent News
thefly.com
2026-01-16
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