Director Of Biostatistics

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 Director of Biostatistics who will be responsible for applying relevant statistical methods to the practice of clinical trial data analysis and interpretations. He/she is also responsible for overseeing quality of the Biostatistics & Statistical Programming Analysis (SPA) generated statistical tables, listings, and graphical presentations of clinical data, and supporting the preparation of regulatory documents (such as study protocols, statistical analysis plans, clinical study reports, integrated summaries of efficacy and safety) and other presentation and publication materials. This role may involve supervision of junior biostatisticians and/or works closely with all Biometrics functions in developing and maintaining relevant Biometrics processes to ensure quality of study data and accuracy of statistical outputs. This is an onsite position reporting to the Vice President, Head of Biostatistics.

RESPONSIBILITIES

• Responsible for applying relevant statistical methods to the practice of clinical trial data summaries and interpretations
• Represent Biometrics function to work with Health Authorities and Key Opinion Leaders as needed
• Provide biostatistics input into drug development plan; work with cross-functional team to design and operationalize clinical studies; provide statistical input in the evaluation, interpretation, and preparation of study results
• Be accountable and responsible for statistics deliverables such as statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations, etc.
• Select, manage, and supervise CROs.
• Assist with resolution of unique queries that may arise during the data management and statistical analysis process
• Provide ad-hoc data listings and summary information per requests
• Participate in developing and maintaining relevant Biostatistics processes to ensure quality of study data and accuracy of statistical outputs
• Perform quality control with respect to the data to be analyzed and the programs to be used for the analysis
• Define processes and perform additional (alternative) quality checks focusing on key efficacy and safety endpoints to ensure validity of data and accuracy of analyses.
• Continue to improve the quality process to ensure the growing requirement of data and output validations
• Managing / supporting the preparation of data package for NDA and other regulatory submissions.
• May mentor junior team members or contractors. Primary role is an individual contributor.

THE IDEAL CANDIDATE

• PhD. degree or equivalent education in Biostatistics with a minimum of 8 years’ experience (or Master with minimum of 10 years) providing statistical analysis and programming support in the biotech/pharmaceutical industry.
• Immunology trials experience is desirable
• Comprehensive and detailed knowledge of statistical experimental design, analysis, and clinical trial requirements
• Demonstrated proficiency with statistical software such as R, SAS
• Ability to work in a regulated environment and adhere to company SOPs and procedures
• Ability to manage workflows and activities to meet department timelines
• Ability to manage deliverables with competing priorities and influence others
• Well-developed critical information seeking and analytical thinking skills
• Strong interpersonal and effective communication (oral and written) skills
• Thorough and strong attention to detail and consistency
• Experience in coaching and managing biostatistics staff is preferred

EDUCATION

• PhD. degree or equivalent education in Biostatistics with a minimum of 8 years’ experience (or Master’s degree or equivalent education with minimum of 10 years)

ALUMIS VALUES:

• We Elevate
• We Challenge
• We Nurture

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

Alumis Inc. is an equal opportunity employer. 

If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster.