Manager Statistical Programming Jobs in Fremont, CA

Reporting to the Chief Medical Officer, the SVP Biometrics will be accountable for biometrics activities for all programs from IND-enabling to registration and launch. This includes leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions. This role requires hands-on execution as well as oversight of internal and external staff. In addition, this person will represent the Biometrics function on the Erasca leadership team and in cross-functional discussions and decision making. The ideal candidate will have excellent technical skills, a track record of developing and mentoring strong teams, significant experience in all phases of oncology drug development, a track record of successful regulatory interactions, and excellent communication skills and executive presence.

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 that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for all programs.
• Demonstrate technical excellence, delivering advanced biometric strategies across the portfolio.
• Act as the subject matter expert for biometrics, advising senior management, development, and clinical operations teams on current biostatistics methodology and tools in drug development.
• In collaboration with VP, Biostatistics, ensure statistical analysis and submission datasets meet regulatory requirements.
• In collaboration with VP, Statistical Programming & Analysis, ensure the intended analyses are performed, and analysis data sets and their specifications are in place.
• In collaboration with Sr Director, Clinical Data Management, provide support to clinical study teams on the collection, interpretation and reporting of clinical data.
• Provide input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for all products.
• Support preparations for interactions with regulatory agencies and provide guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, etc.). Represent biometrics in interactions with regulatory agencies and health authorities.
• Review and comment on eCRFs, annotated eCRFs, edit checks 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 further embed biometrics SOPs, processes, and relevant quality management system.
• Ensure appropriate resourcing of the biometrics organization by anticipating needs and filling gaps, as needed, with consultants, contractors, and/or employees.
• Mentor and promote the professional development of Biometrics team members.
• Up to 25% travel may be required, possible international travel.
• Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

Required Education and Experience: 

• Minimum of 15 years relevant experience in the pharmaceutical or biotechnology industry, ideally including both large and small company experience.
• PhD degree in statistics or biostatistics required.
• A hands on and flexible leader, comfortable as a subject matter expert for biometrics as well as contributing at the leadership team and leading and managing highly accomplished function managers.
• Experience in oncology drug development required, ideally from FIH to registration.
• Direct experience leading and working in Biostatistics required as well as experience leading Statistical Programming and/or Clinical Data Management.
• Extensive knowledge of clinical research methodology and regulatory requirements as they relate to trial design and analysis.
• Good knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skill, SAS, SDTM, and CDISC.
• Extensive experience negotiating successfully with health authorities.
• Excellent analytical and organizational skills.
• Track record of successfully working within individual protocols and across programs to design, drive, and execute statistical strategy.
• Proven ability to attract, develop, and manage top notch talent including a mix of internal and contingent staff.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Executive leadership skills to educate and influence stakeholders and to add value in strategic business planning and decision-making.  
• Effective interpersonal, communication, and influencing skills, including strong writing and presentation skills, with the ability to tailor communication style to diverse audiences and situations.  
• 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.

The anticipated salary range for this position is $350,000 to $415,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.