SVP Biometrics

Erasca, Inc.; San Diego (CA); On-site; USD 350,000 - 415,000; Full time

Benefits offered by this job

Paid Time Off

401(k) Plan with company contribution

Employee Stock Purchase Program

Medical, Dental, and Vision Plans

Job summary

Erasca, Inc. is seeking a Senior Vice President of Biometrics based in San Diego, California. This role demands leadership in Biostatistics, Statistical Programming, and Clinical Data Management, guiding drug development from IND to launch.

The ideal candidate will possess a PhD in statistics, with 15+ years in the pharmaceutical industry, particularly in oncology. Competitive salary ranges from $350,000 to $415,000, alongside substantial benefits including health plans and a 401(k) plan with company contributions.

Qualifications

• Minimum of 15 years of relevant experience in the pharmaceutical or biotechnology industry.
• Hands-on and flexible leader comfortable as a subject-matter expert.
• Experience in oncology drug development required, from FIH to registration.

Responsibilities

• Lead a high-performing team across Biostatistics, Statistical Programming & Analysis, and Clinical Data Management.
• Ensure statistical analysis meets regulatory requirements.
• Review clinical study reports and safety reports for quality.

Skills

Leadership

Biostatistics expertise

Pharmaceutical industry knowledge

Clinical research methodology

Regulatory knowledge

Education

PhD in statistics or biostatistics

Tools

SAS

SDTM

CDISC

Job description

Company Overview

Erascais is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. Its programs target the RAS/MAPK pathway, a signaling cascade mutated in approximately 5.5 million lives each year worldwide. The name "Erasca" is an acronym for "erase cancer," reflecting the company’s mission.

Role Summary

Reporting to the Chief Medical Officer, the SVP Biometrics will lead the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions across all phases of drug development, from IND‑enabling to registration and launch. The position also represents the Biometrics function on the Erasca leadership team and in cross‑functional decision‑making.

Essential Duties and Responsibilities

• Build, maintain, and develop a high‑performing team across Biostatistics, Statistical Programming & Analysis, and Clinical Data Management.
• Ensure systems, capabilities, and resources are in place to optimize the design, conduct, analysis, and interpretation of clinical and nonclinical data for all programs.
• Deliver advanced biometric strategies across the portfolio with technical excellence.
• Act as the subject matter expert for biometrics, advising senior management, development, and clinical operations teams on current biostatistics methodology and tools.
• Collaborate with the VP of Biostatistics to ensure statistical analysis and submission datasets meet regulatory requirements.
• Collaborate with the VP of Statistical Programming & Analysis to ensure intended analyses are performed and analysis data sets and specifications are in place.
• Collaborate with the Senior Director of Clinical Data Management to support clinical study teams on data collection, interpretation, and reporting.
• Provide input on key development documents, including clinical protocols, study reports, Investigational Brochures, INDs, NDAs, and labeling.
• Support preparation for interactions with regulatory agencies and guide the high‑quality preparation of regulatory documents such as clinical study reports and safety reports.
• Represent biometrics in interactions with regulatory agencies and health authorities.
• Review and comment on eCRFs, annotated eCRFs, edit‑check documents, and other clinical data‑management related documents.
• Stay abreast of emerging technologies and concepts related to applied statistical methodology.
• Lead biometrics due diligence in support of business and corporate development activities.
• Establish and embed biometrics SOPs, processes, and relevant quality management systems.
• Ensure appropriate resourcing of the biometrics organization by anticipating needs and filling gaps with consultants, contractors, and/or employees.
• Mentor and promote the professional development of the Biometrics team members.
• Up to 25% travel may be required; international travel possible.
• Perform all duties in keeping with the company’s core values, policies, and applicable regulations.

Required Education and Experience

• Minimum of 15 years of relevant experience in the pharmaceutical or biotechnology industry, ideally including both large and small company experience.
• PhD degree in statistics or biostatistics required.
• Hands‑on and flexible leader comfortable as a subject‑matter expert for biometrics and as a leader of highly accomplished function managers.
• Experience in oncology drug development required, ideally from FIH to registration.
• Direct experience leading and working in Biostatistics, Statistical Programming, and/or Clinical Data Management required.
• Extensive knowledge of clinical research methodology and regulatory requirements related to trial design and analysis.
• Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong technical skills in SAS, SDTM, and CDISC.
• Extensive experience negotiating successfully with health authorities.
• Excellent analytical and organizational skills.
• Track record of designing, driving, and executing statistical strategy within individual protocols and across programs.
• Proven ability to attract, develop, and manage top‑notch talent, including internal and contingent staff.
• Highly collaborative team player fostering open communication and mutual understanding among stakeholders.
• Executive leadership skills to educate and influence stakeholders and add value in strategic business planning and decision making.
• Effective interpersonal, communication, and influencing skills; strong writing and presentation skills adaptable to diverse audiences.
• Demonstrated ability to achieve high‑performance goals and meet deadlines in a fast‑paced environment.
• Strong learning orientation, curiosity, and commitment to science and patients.

Compensation & Benefits

Salary range: $350,000 to $415,000. Additional compensation may include annual bonus and equity grants at hire and annually.

Benefits include Paid Time Off, Holiday and Sick Leave; Medical, Dental and Vision Plans; Short‑ and Long‑Term Disability; Basic and Voluntary Life/AD&D; Flexible Spending Accounts (FSA, HSA, and Commute); Critical Illness and Accident Coverage; Pet Insurance; Employee Assistance Program; 401(k) Plan with Erasca contribution; and Employee Stock Purchase Program.

Equal Employment Opportunity

Erasca, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of sex, race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.