Executive Director, Biostatistics and Data Management

 

 

Executive Director, Biostatistics & Data Management

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.

The company is progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102, targeting LRRK2 for neurodegenerative disorders; and ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma.

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. 

 

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

 

Qualifi