SVP, Biometrics

📋 Description

• Reporting to the Chief Medical Officer, the SVP Biometrics will oversee biometrics activities for all programs from IND-enabling through to registration and launch.

• This role encompasses leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions.

• The position necessitates hands-on execution alongside the oversight of both internal and external personnel.

• Furthermore, this individual will serve as a representative of the Biometrics function within the Erasca leadership team and during cross-functional discussions and decision-making processes.

• Build, sustain, and cultivate a high-performing team across Biostatistics, Statistical Programming, and Clinical Data Management.

• Ensure that systems, capabilities, and resources are established to enhance the design, execution, analysis, and interpretation of clinical and nonclinical data for all programs.

• Exhibit technical excellence by delivering advanced biometric strategies throughout the portfolio.

• Act as the subject matter expert in biometrics, providing counsel to senior management, development teams, and clinical operations on contemporary biostatistics methodologies and tools in drug development.

• Collaborate with the VP of Biostatistics to ensure that statistical analyses and submission datasets comply with regulatory standards.

• Work alongside the VP of Statistical Programming & Analysis to confirm that intended analyses are conducted and that analysis datasets and their specifications are established.

• Partner with the Sr. Director of Clinical Data Management to offer support to clinical study teams regarding the collection, interpretation, and reporting of clinical data.

• Contribute input on crucial development documents, clinical protocols, study reports, IBs, INDs, NDAs, and product labeling.

• Aid in preparations for engagements with regulatory agencies and offer guidance to ensure the meticulous preparation of Regulatory Authority documents.

⛳️ Requirements

• A minimum of 15 years of pertinent experience in the pharmaceutical or biotechnology sector, ideally encompassing experience in both large and small companies.

• A PhD in statistics or biostatistics is required.

• A hands-on and adaptable leader, comfortable being a subject matter expert in biometrics while also contributing to the leadership team and managing highly skilled function managers.

• Experience in oncology drug development is essential, ideally from FIH to registration.

• Direct experience in leading and working within Biostatistics is required, along with experience in leading Statistical Programming and/or Clinical Data Management.

• Extensive understanding of clinical research methodologies and regulatory requirements related to trial design and analysis.

• Solid knowledge of ICH, FDA, and GCP regulations and guidelines; robust technical skills in SAS, SDTM, and CDISC.

• Extensive experience in successfully negotiating with health authorities.

• Exceptional analytical and organizational abilities.

• A proven history of effectively working within individual protocols and across programs to design, drive, and execute statistical strategies.

• Demonstrated ability to attract, develop, and manage top-tier talent, including a blend of internal and contingent staff.

• A highly collaborative team player who promotes open communication and encourages mutual understanding and cooperation among all stakeholders.

• Executive leadership capabilities to educate and influence stakeholders, adding value to strategic business planning and decision-making.

• Strong interpersonal, communication, and influencing skills, including excellent writing and presentation skills, with the ability to adjust communication styles to suit diverse audiences and situations.

• Proven ability to achieve high-performance goals and meet deadlines in a fast-paced environment.

• A strong orientation towards learning, curiosity, and a commitment to science and patient care.

🏝️ Benefits

• Paid Time Off

• Holiday

• Sick Leave

• Medical, Dental and Vision Plans

• Short- and Long-Term Disability

• Basic and Voluntary Life/AD&D Coverage

• Flexible Spending Accounts (FSA, HSA, and Commute)

• Critical Illness and Accident Coverage

• Pet Insurance

• Employee Assistance Program

• 401(k) Plan with Erasca contribution

• Opportunity to participate in an Employee Stock Purchase Program