Director, Biostatistics

BioSpace; South San Francisco (CA); Hybrid; USD 245,000 - 255,000; Full time

Job summary

An established industry player is seeking a Director of Biostatistics to provide statistical leadership across multiple clinical trials. This pivotal role involves developing statistical analysis plans, ensuring data quality, and collaborating on regulatory submissions. Ideal candidates will possess a Ph.D. in Biostatistics or a Master's with significant experience, showcasing strong expertise in statistical methods and clinical trial analysis. Join a high-performing team dedicated to transforming patient outcomes in autoimmune diseases, where your contributions will significantly impact innovative therapies and clinical development.

Benefits

Health insurance premiums paid at 90% for employee

Free access to Genentech Bus & Ferry Share program

$100 monthly cell phone stipend

Unlimited PTO for Exempt employees

Free onsite gym and stocked kitchen

Qualifications

• Ph.D. or Master’s with extensive experience in biostatistics.
• Strong expertise in statistical experimental design and regulatory submissions.

Responsibilities

• Lead statistical analysis for Phase 2 and 3 clinical trials.
• Oversee statistical deliverables and manage CRO partners.

Skills

Statistical Analysis

Clinical Trial Design

R Software

SAS Software

Analytical Thinking

Attention to Detail

Communication Skills

Education

Ph.D. in Biostatistics

Master’s in Biostatistics

Tools

R

SAS

Job description

Join to apply for the Director, Biostatistics role at BioSpace

4 days ago Be among the first 25 applicants

Join to apply for the Director, Biostatistics role at BioSpace

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 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.
  
  
  

Education

The Ideal Candidate:

• 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, with an expectation to be onsite Tuesday through Thursday. While we prefer local candidates, remote applicants based in the Pacific Time Zone will be considered on a case-by-case basis.

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 elevate, challenge and nurture one another along the way.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Internet News

Referrals increase your chances of interviewing at BioSpace by 2x

Sign in to set job alerts for “Director Biostatistics” roles.

South San Francisco, CA $260,687.00-$322,025.00 3 months ago

Vice President, Measurement Science & Statistics

San Francisco, CA $215,000.00-$285,000.00 3 months ago

San Mateo County, CA $260,000.00-$310,000.00 1 week ago

San Francisco, CA $260,000.00-$300,000.00 3 weeks ago

South San Francisco, CA $260,000.00-$322,000.00 2 weeks ago

San Francisco, CA $253,000.00-$314,000.00 2 weeks ago

South San Francisco, CA $250,000.00-$315,000.00 3 weeks ago

Menlo Park, CA $253,000.00-$314,000.00 2 weeks ago

Director of Finance and Administration, Biomedical Data Science

Stanford, CA $205,050.00-$283,688.00 2 weeks ago

Director of Finance and Administration, Biomedical Data Science

Stanford, CA $205,050.00-$283,688.00 5 months ago

San Francisco, CA $250,000.00-$270,000.00 3 weeks ago

San Francisco, CA $230,000.00-$270,000.00 16 hours ago

San Francisco, CA $215,000.00-$270,000.00 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.