What are the responsibilities and job description for the Director, Biostatistics position at Jobleads-US?
About Us
Alumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases.
Even with treatment innovations over the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
Job Summary
We are seeking an Associate Director of Biostatistics to provide statistical leadership across multiple Phase 2 and 3 clinical trials.
This role requires expertise in simulation work, multiple imputation analyses, and late-phase clinical development.
The successful candidate will have substantial filing knowledge and hands-on experience to play a critical role in the execution of the development of our lead compound.
Key Responsibilities
- Provide Statistical Leadership: Apply advanced statistical methods to clinical trial data summaries and interpretations including integrated safety and efficacy analyses to support regulatory submissions.
- Contribute to Drug Development Plans: Provide statistical input for drug development plans, clinical study design, and operationalization.
- Manage CROs: Manage and oversee CROs.
- Ensure Data Quality: Ensure the quality and accuracy of study data and statistical outputs.
- Mentor Junior Staff: Mentor junior staff and contractors, while primarily serving as an individual contributor.
Requirements
- 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.
- Skills: Excellent analytical thinking, attention to detail, and communication (written and oral).
The ideal candidate will have a strong 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 is required.
Immunology experience is preferred.
A proven ability to manage deliverables with competing priorities is essential.
This position is located in South San Francisco, CA.
Employees are expected to be onsite Tuesday-Thursday.
