Erasca, Inc.
Exec Director & Head, Biostatistics
Erasca, Inc., South San Francisco, California, us, 94083
Position Summary:
Reporting to the VP Biometrics, the Executive Director & Head of Biostatistics will be responsible for providing statistical leadership and strategic partnership in the development of clinical development plans, health authority interactions, research, and development science. As the head of the Biostatistics function, represent function in broader drug-development strategies and team meetings in addition to serving as program or study statistical lead for clinical development projects through the product life cycle.
Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.
Essential Duties and Responsibilities:
Provide statistical leadership for clinical development projects, including strategic input into clinical development plans.
Be responsible for the statistical integrity, adequacy, and accuracy of clinical studies.
Ensure study designs are aligned with the project strategy, and statistical methodology is appropriate, sound, and meets scientific and/or regulatory needs.
Be accountable for the statistical input for clinical and regulatory documents for assigned projects, including protocols, statistical analysis plans, clinical study reports, publication and presentations, and others.
Collaborate with other functions to provide statistical leadership in the development and implementation of data collection instruments.
Be the biostatistics lead for Health Authority interactions for assigned projects.
Lead cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation.
Interact with internal and external stakeholders (e.g., vendors, committees) in support of clinical trial objectives.
Serve as expert statistical consultant for research and development science.
Oversee the deliverables from statistical CROs.
Manage functional contractors or CRO staff.
Over time and aligned to business and program needs, build a high-functioning Biostatistics department.
Ensure adherence to business processes and encourage consistent approaches to biostatistics accountabilities.
Engage in research in statistics to improve drug development methodology consistent with corporate priorities and timeline.
Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.
Education and Experience:
PhD in Statistics, Biostatistics, Mathematics, or similar areas of academic discipline required.
At least 8 years of biotech or pharmaceutical industry experience as a biostatistician, including experience overseeing statistical group activities.
Experience in design and analysis of oncology clinical trials required.
Must be familiar with the entire drug development path including early and late-stage development and regulatory filing.
Experience as the statistics lead in global Health Authority interactions.
Proficient in SAS, programming in R a plus.
Solid understanding of CDISC models and standards.
Expert knowledge of drug development strategies and regulations, especially those pertinent to statistical analyses.
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
Excellent oral and written communication skills with the ability to lead cross-functional interactions and deliver on team objectives.
Strong learning orientation, curiosity, and commitment to science and patients.
The anticipated salary range for this position is $250,000 to $285,000. 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, etc. 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.
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Reporting to the VP Biometrics, the Executive Director & Head of Biostatistics will be responsible for providing statistical leadership and strategic partnership in the development of clinical development plans, health authority interactions, research, and development science. As the head of the Biostatistics function, represent function in broader drug-development strategies and team meetings in addition to serving as program or study statistical lead for clinical development projects through the product life cycle.
Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.
Essential Duties and Responsibilities:
Provide statistical leadership for clinical development projects, including strategic input into clinical development plans.
Be responsible for the statistical integrity, adequacy, and accuracy of clinical studies.
Ensure study designs are aligned with the project strategy, and statistical methodology is appropriate, sound, and meets scientific and/or regulatory needs.
Be accountable for the statistical input for clinical and regulatory documents for assigned projects, including protocols, statistical analysis plans, clinical study reports, publication and presentations, and others.
Collaborate with other functions to provide statistical leadership in the development and implementation of data collection instruments.
Be the biostatistics lead for Health Authority interactions for assigned projects.
Lead cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation.
Interact with internal and external stakeholders (e.g., vendors, committees) in support of clinical trial objectives.
Serve as expert statistical consultant for research and development science.
Oversee the deliverables from statistical CROs.
Manage functional contractors or CRO staff.
Over time and aligned to business and program needs, build a high-functioning Biostatistics department.
Ensure adherence to business processes and encourage consistent approaches to biostatistics accountabilities.
Engage in research in statistics to improve drug development methodology consistent with corporate priorities and timeline.
Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.
Education and Experience:
PhD in Statistics, Biostatistics, Mathematics, or similar areas of academic discipline required.
At least 8 years of biotech or pharmaceutical industry experience as a biostatistician, including experience overseeing statistical group activities.
Experience in design and analysis of oncology clinical trials required.
Must be familiar with the entire drug development path including early and late-stage development and regulatory filing.
Experience as the statistics lead in global Health Authority interactions.
Proficient in SAS, programming in R a plus.
Solid understanding of CDISC models and standards.
Expert knowledge of drug development strategies and regulations, especially those pertinent to statistical analyses.
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems.
Excellent oral and written communication skills with the ability to lead cross-functional interactions and deliver on team objectives.
Strong learning orientation, curiosity, and commitment to science and patients.
The anticipated salary range for this position is $250,000 to $285,000. 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, etc. 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.
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