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Director, Statistical Programming

2 months ago

South San Francisco, United States Alumis Full time
Job DescriptionJob DescriptionSalary:

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 Statistical Programming Director who will be primarily responsible for overseeing statistical programming activities in a drug development program and ensuring programming activities in compliance with SOPs and regulatory requirements to produce quality and timely deliverables.


Responsibilities


  • Lead statistical programming for study/indication; represent the statistical programming team at Study Execution Team and Clinical Development Team to address deliverables and timelines.
  • Contribute to strategies for programming-related matters in submission to regulatory agencies, publications and other communications as needed.
  • Provide technical leadership and guidance to programming team and vendors on conventions, best practices, standards, specifications, and solutions to complex programming tasks.
  • Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables.
  • Participate in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans, and other clinical documents.
  • Lead/contribute to departmental process and standards initiatives such as the development of processes and CDISC standards.
  • Develop product- and study-level macros and utilities to improve programming efficiency.
  • Oversee CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs.
  • Conduct ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards.
  • Advanced knowledge of submission requirements and standards; ensure statistical programming activities are in compliance with regulatory requirements, industry and company standards; accountable for quality deliverables.


The Ideal Candidate


  • Expert level SAS programmer with experience in delivering complex programming assignments and analysis. Proficient in developing their own code including macros as well as modifying existing code.
  • Experience in development and implementation of statistical programming standards and procedures
  • Expert-level knowledge and extensive hands-on experience with CDISC standards such as CDASH, SDTM, and ADaM
  • Experience leading teams supporting FDA/EMEA/CDE filings.
  • Strong interpersonal and effective communication (oral and written) skills.
  • Thorough and strong attention to detail and consistency


Education


Bachelor’s degree or equivalent education, preferably in a computational or biological science, with a minimum of 12 years of directly related experience in a drug development environment. Or Master’s degree with a minimum of 10 years of related experience.


Alumis Values


  • Elevate
  • Challenge
  • Nurture


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 $220,000 USD to $234,000 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.