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 Senior Vice President, Biometrics position at Alumis is a strategic executive role, key to shaping the vision and impact of Biostatistics, Data Management, and Statistical Programming. As a critical leader within the organization, you will shape the direction of our biometrics strategy, ensuring our clinical trials are designed, analyzed, and reported with rigorous attention to quality, regulatory compliance, and strategic alignment with corporate objectives. This role demands an inspiring, results-oriented leader who excels in both high-level strategy and detailed operational oversight, ensuring biometrics initiatives are executed efficiently, accurately, and with the utmost integrity.
In this influential position, you will collaborate closely with executive leadership, championing Alumis’s values by fostering an environment where innovation, transparency, and excellence thrive. Your expertise and vision will be essential in driving data-driven decision-making across clinical programs and empowering teams to produce high-quality, timely insights. Reporting to the Chief Medical Officer, you will lead with passion and strategic foresight, navigating complex technical and regulatory landscapes to advance our mission and deliver transformative therapies to patients.
Essential Responsibilities
- Develop and implement a comprehensive biometrics strategy that aligns with the company’s clinical and regulatory goals.
- Provide visionary leadership for Biostatistics, Data Management, and Statistical Programming, fostering a culture of innovation, collaboration, and scientific rigor.
- Partner closely with the executive team to shape clinical development strategies informed by statistical and data-driven insights.
- Ensure precise design, analysis, and interpretation of clinical trials to support regulatory submissions, publications, and corporate milestones.
- Drive the highest standards in data quality, integrity, and compliance, establishing robust processes that meet regulatory and industry standards, including ICH and FDA guidelines.
- Oversee effective data management practices, ensuring data completeness, accuracy, and adherence to Good Clinical Data Management Practices (GCDMP).
- Collaborate with Clinical Development, Regulatory, Medical Affairs, and other key stakeholders to support the full clinical trial lifecycle, from protocol development to data analysis and reporting.
- Represent biometrics functions in interactions with regulatory agencies, including FDA, EMA, and other global health authorities.
- Provide expert input into clinical development plans, study protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs).
- Build and nurture a high-performing biometrics team, supporting professional growth and aligning team goals with the company’s mission and objectives.
- Foster a culture of continuous learning within the biometrics function to stay current with industry advancements, best practices, and regulatory requirements.
- Champion the adoption of innovative statistical methodologies and advanced data analytics technologies, such as AI and machine learning, to enhance trial design, data analysis, and operational efficiency.
- Drive process improvements and implement tools and systems that optimize the performance and scalability of the biometrics team.
Professional Experience / Qualifications:
- Proven ability to define and implement biometrics strategies that align with broader corporate objectives, with a strong aptitude for managing both strategic and operational aspects of clinical trials.
- Extensive experience in regulatory submissions, including NDAs, BLAs, and international filings, with a successful track record in regulatory agency interactions.
- Expertise in clinical trial design, statistical methodologies, data analysis, and comprehensive reporting.
- In-depth knowledge of regulatory requirements, including ICH guidelines and regulations from FDA, EMA, and other global health authorities.
- Skilled in shaping clinical and regulatory strategies through data-driven insights.
- Exceptional leadership, communication, and collaboration skills, with experience building and leading high-performing teams.
- Advanced proficiency in statistical software (e.g., SAS, R) and familiarity with clinical data management systems.
Preferred Education:
- PhD or MS in Biostatistics, Statistics, Mathematics, or a related field.
Preferred Experience:
- Minimum 20 years of relevant industry experience, with 10+ years in a senior management position, including a track record of developing and implementing biometrics strategies for large, complex, global clinical trials.
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 elevate, challenge and nurture one another along the way.
*Lab personnel are generally onsite 4-5 days/week.
Top Skills
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.
