New

Senior Manager, Statistical Programming

San Francisco

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

  • Expert-level SAS programmer with a proven track-record of delivering complex programming assignments and analyses. 
  • Skilled in writing original cold, 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. 

Education Requirement

  • 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. 

The salary range for this position is $185,000 USD to $200,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.*  At this time we are not considering remote applicants.

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.

*Alumis Lab personnel are generally onsite 4-5 days/week 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Alumis’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.