Job description
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.
In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs currently enrolling: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102 for the treatment of patients with neurodegenerative disorders, and ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas.
In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC® androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.
#TeamArvinas is made up of passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.
For more information, please visit www.arvinas.com.
Position Summary
The Executive Director, Biostatics and Data Management will play a critical leadership role and participate in developing and implementing the strategic plans for Arvinas clinical developments by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process. The Executive Director of Biostatistics and Data Management will provide technical support for ongoing clinical trials, FDA submissions, publications and other business needs.
This position reports to the Chief Medical Officer and can be remote, hybrid or located at our headquarters in New Haven, CT.
Principal Responsibilities
Key responsibilities of this role include, but are not limited to:
Be accountable for leading the biostatistics strategy in all Arvinas clinical development projects.
Provide statistical leadership into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives
Provide oversight of CRO and statistical vendors externally to ensure quality of all statistical deliverables and adherence to requirements/timeline.
Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, clinical operations, medical affairs, medical writing etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program
Develop and implement department standards, processes and practices to ensure statistical integrity of project deliverables.
Build biostatistics talent team at Arvinas. Develop and mentor junior statisticians to help grow the department.
Oversee data management team at Arvinas. Develop and mentor data management team to help grow the department
Develop functional biostatistics infrastructure and capabilities
Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making
Incorporate generative AI into the workflow of the group and document increased efficiency
Qualifications
- 15+ years of experience in pharmaceutical/biotech clinical drug development. 10+ years of oncology experience is required. Past NDA/BLA submission experience is preferred.
- Proficiency in statistical programming languages/software such as SAS, R, etc.
- Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines; In-depth knowledge of the global drug development process.
- Demonstrated written and oral communication skills and ability to work within a team and work independently are required.
- Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.
- Desire to work in a fast-paced, innovative environment
- Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future.
- The duties of this role are generally conducted in a combination of lab and home office environments. Employees must be able, with or without an accommodation to lift/carry 15⁄30 pounds unassisted/assisted; work comfortable in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
Education
- Ph.D. in Statistic, Biostatistics, Mathematics or related field
#LI-Remote
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity Employer
