Senior Manager, Statistical Programming

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  

• 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.   

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.