Executive Director or Vice President, Biometrics

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

POSITION SUMMARY:

Reporting to the Chief Medical Officer, the Vice President, Biometrics will be responsible for overseeing all aspects of biometrics, including statistical analysis, data management, and programming, to support the design, analysis, and reporting of clinical trials. This role requires a strategic thinker with deep expertise in biometrics, a strong understanding of regulatory requirements, and the ability to collaborate cross-functionally to drive clinical development programs forward. The ideal candidate will have a proven track record of leading biometrics teams in the biotech or pharmaceutical industry, with experience in late-stage clinical development and a strong understanding of global regulatory standards.

PRIMARY RESPONSIBILITIES AND DUTIES:

· Provide strategic leadership for the biometrics function (biostatistics, programming, and data management), ensuring alignment with overall clinical development goals.

· Develop and implement innovative statistical methodologies and data management practices to enhance trial design, analysis, and interpretation.

· Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Medical Affairs, to shape clinical development plans and regulatory submissions.

· Oversee the design of clinical trials including sample size calculations, randomization, and statistical analysis plans (SAPs).

· Ensure the appropriate application of statistical methods for data analysis and interpretation.

· Review and approve key statistical deliverables, including tables, figures, and listings (TFLs), and contribute to clinical study reports (CSRs).

· Oversee the development and validation of statistical programming deliverables, including SDTM and ADaM datasets, ensuring compliance with CDISC standards and other regulatory requirements.

 · Oversee the use of programming tools and technologies to streamline processes and improve efficiency.

· Direct the development and implementation of data management strategies, including case report form (CRF) design, data validation, and database lock activities.

· Ensure data integrity, quality, and compliance with regulatory standards.

· Collaborate with external vendors and partners to oversee data collection, data analysis and management activities.

· Provide biometrics expertise to support regulatory interactions, including the preparation of briefing documents, responses to regulatory queries, and submissions.

· Establish and maintain standard operating procedures (SOPs) and best practices for biometrics functions.

· Ensure that all biometrics deliverables meet regulatory requirements and are submitted on time.

· Build, mentor, and lead a high-performing biometrics team, fostering a culture of collaboration, innovation, and excellence.

· Provide guidance and professional development opportunities to team members.

QUALIFICATIONS AND SKILLS:

· PhD degree in Biostatistics or equivalent with 12 years (or MS degree with 15 years) of experience in the statistical analysis of biomedical data using statistical software.

· Minimum of 10 years of experience in biometrics within the biotech or pharmaceutical industry.

· Proven track record of leading biometrics teams and supporting early and late-stage clinical development programs.

· Experience with global regulatory submissions (e.g., FDA, EMA) and familiarity with ICH guidelines.

· Strong knowledge of CDISC standards, including SDTM and ADaM.

· Experience with statistical software (e.g., SAS, R) and data visualization tools.

· Exceptional leadership and team-building skills.

· Strong strategic thinking and problem-solving abilities.

· Excellent communication and collaboration skills, with the ability to work effectively across functions.

· High level of attention to detail and commitment to data quality.

· Ability to thrive in a fast-paced, dynamic environment.

· Extensive hands-on experience in oncology drug development including design and analysis of early and late phase oncology trials.

· Good understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company.

· Demonstrated effective verbal and written communication skills and interpersonal skills.

· Makes effective decisions with limited information.

· Proven effective interpersonal skills to create collaborative relationships within the function as well as with all cross functional organizations.

· Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).

Salary: $312,000-$370,000 DOE  

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

Salary : $312,000 - $370,000