Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.
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
- Serves 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, 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.
Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and 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, and the opportunity to participate in an Employee Stock Purchase Program.
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.
Top Skills
What We Do
Our mission at Erasca is embedded in our name: To erase cancer.
Energized by recent scientific discoveries and advances in drugging various biological drivers of cancer, we are committed to solving oncology’s hardest problems. We have assembled a proven team and joined forces with world-class collaborators who embrace our ambitious goals.
