Director, Biostatistics

Posted 8 Hours Ago
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South San Francisco, CA
Senior level
Biotech
The Role
The Director of Biostatistics at Alumis Inc. will provide statistical leadership for Phase 2 and 3 clinical trials, overseeing statistical analysis plans and ensuring quality in deliverables. This role involves hands-on contributions to clinical study reports and integrated analyses for regulatory submissions, and will mentor junior team members while managing CRO partners.
Summary Generated by Built In

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. 

The Associate Director of Biostatistics will play a key role in providing statistical leadership across multiple Phase 2 and 3 clinical trials. As the statistical lead, you will develop and oversee statistical analysis plans, ensure the quality and accuracy of deliverables, and manage CRO partners to meet project timelines and standards. This role requires expertise in simulation work, multiple imputation analyses, and late-phase clinical development.

As the Director of Biostatistics at Alumis, you will join a high-performing team of experienced drug developers dedicated to transforming outcomes for patients with autoimmune diseases. We are seeking someone with substantial filing knowledge and hands-on experience to play a critical role in the execution of the development of our lead compound. You will oversee the quality and accuracy of statistical analyses, and collaborate cross-functionally to develop integrated analyses for regulatory submissions. This role involves hands-on contributions to key statistical deliverables, such as analysis plans, clinical study reports, and data packages for regulatory submissions, while managing CROs and mentoring junior team members. Guided by our core values—We Elevate, We Challenge, We Nurture—you will play a pivotal role in advancing innovative therapies alongside a talented and experienced team.

Essential Responsibilities:

  • Apply advanced statistical methods to clinical trial data summaries and interpretations including integrated safety and efficacy analyses to support regulatory submissions.
  • Provide statistical input for drug development plans, clinical study design, and operationalization.
  • Perform as study statistician including the development or review of statistical analysis plans, clinical study reports, and presentations.
  • Manage and oversee CROs.
  • Ensure the quality and accuracy of study data and statistical outputs.
  • Perform quality control checks on key efficacy and safety endpoints to validate data.
  • Mentor junior staff and contractors, while primarily serving as an individual contributor.

The Ideal Candidate:

Education: 

  • Ph.D. in Biostatistics with at least 8 years of experience, or Master’s with a minimum of 10 years of directly relevant experience in the biopharma industry.

Experience: 

  • Strong expertise in statistical experimental design, clinical trial analysis, and regulatory requirements.
  • Proven track record of planning, creating, and delivering Integrated Summaries of Safety and Effectiveness (ISS and ISE) and related reports for regulatory submissions.
  • Proficiency with R and SAS software.
  • Immunology experience preferred.
  • Proven ability to manage deliverables with competing priorities.

Skills: 

  • Excellent analytical thinking, attention to detail, and communication (written and oral). 
  • Demonstrated ability to work in a regulated environment and adhere to SOPs. 
  • Strong interpersonal skills and ability to influence cross-functional teams. 
  • Experience coaching and managing biostatistics staff is a plus. 

The salary range for this position is $245,000 USD to $255,000 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 elevatechallenge and nurture one another along the way.

Top Skills

R
SAS
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The Company
HQ: South San Francisco, California
162 Employees
On-site Workplace
Year Founded: 2021

What We Do

At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies.

We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects.

Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction.

Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.

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