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Director, Biostatistics

Employer
Alumis Inc.
Location
South San Francisco, California
Start date
Apr 14, 2024

View more

Discipline
Science/R&D, Biostatistics
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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 lead and oversee the biostatistical activities for one of the late-stage clinical programs for our leading molecule. He/she will be responsible for applying relevant statistical methods to the practice of clinical trial data analysis and interpretations. This person will be also responsible for overseeing the 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 the supervision of junior biostatisticians and/or working closely with all Biometrics functions in developing and maintaining relevant Biometrics processes to ensure the quality of study data and the accuracy of statistical outputs. This position reports to the Vice President, Head of Biostatistics and Statistical Programming.


Responsibilities


  • Lead and oversee biostatistical activities for one of the late-stage clinical programs for the leading molecule
  • 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 statistical deliverables such as statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations, etc.
  • 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
  • Manage/ support the preparation of data packages for NDA and other regulatory submissions.
  • Select, manage, and supervise CROs.
  • May mentor junior team members or contractors as needed.


The ideal candidate


  • Ph.D. 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/or managing biostatistics staff is preferred but not required


Education 


  • Ph.D. 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


  • Elevate
  • Challenge
  • Nurture


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


The salary range for this position is $240,000 – $260,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.


Alumis Inc. is an equal opportunity employer.

Company

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Our experienced leadership team brings a proven track record in precision drug development of groundbreaking therapies.

Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer.

With a unique precision analytics platform and an unwavering commitment to advancing our understanding of immunologic diseases, Alumis Inc. will rewrite the autoimmune treatment playbook by developing the right medicine for each patient.
 

Company info
Website
Location
611 Gateway Blvd
Suite 820
South San Francisco
California
94080
US

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