Open Positions: Director, Biostatistics
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 350 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 purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
The Director, Biostatistics 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 Director of Biostatistics will provide technical support for ongoing clinical trials, FDA submissions, publications and other business needs.
This position reports to the head of Biostatistics and Data Management and can be remote, hybrid or located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- 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, data management, statistical programming, 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.
- Participate and lead in process improvement, training, SOP development, enhancing statistical technical expertise and building biostatistics team at Arvinas.
- Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
- 10+ years of experience in clinical drug development. Past NDA/BLA submission experience is desirable.
- 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.
- Ph.D. in Statistic, Biostatistics, Mathematics or related field
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