The Director, Biostatistics, will grow and lead the biostatistics function at Wave Life Sciences and be responsible for providing statistical leadership for clinical studies of stereopure nucleic acid therapeutics that precisely target the underlying cause of rare diseases. Reporting to the Vice President of Biometrics, the successful candidate will provide strategic, operational and technical leadership for all phases of drug development. Primary responsibilities include collaborating with clinical trial teams on the design, implementation and analysis of clinical trials and establishing and developing a high-performing, creative and efficient biostatistics team. The successful candidate should be able to work in multiple therapeutic areas and have a keen interest in innovative clinical trial methodology such as adaptive design and experience in trial modelling and simulation.
This is an exciting opportunity to work for a dynamic, cutting edge biotechnology company.
- Provide expertise and guidance in clinical study design and implement efficient and effective practices in the execution and analysis of clinical trials.
- Assume leadership and managerial role for providing statistical support for the clinical development portfolio.
- Produce or oversee the creation of statistical analysis plans including datasets, tables, listings and figures specifications.
- Conduct clinical trial simulations to optimize the selection of clinical trial endpoints, statistical analysis methods and clinical trial design
- Lead the development and application of new statistical methodology in support of research and development and keep abreast of regulatory guidance and requirements in the global environment with a focus on rare diseases.
- Collaborate effectively with internal and external statistical programmers and data managers.
- Ensure successful study designs and development plans that incorporate forward-thinking statistical strategies.
- Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs and seek to optimize resource utilization.
- Establish best practices and operational guidance for the biostatistics function.
- Provide oversight and guidance to external resources including contract research organizations and contractors.
- Communicate effectively with internal team members and senior management.
- Advanced degree in Biostatistics/Statistics (Ph.D. preferred) and 8 or more years of biotech/pharmaceutical experience
- Comprehensive knowledge of statistical methodology with demonstrated ability of applying advanced methods in clinical trial design and analysis
- Excellent communication, negotiation and writing skills including the ability to clearly describe advanced statistical techniques and interpret results
- Experience with conducting sophisticated clinical trial simulation
- Thorough and up-to-date working knowledge of SAS and/or R
- Flexible, well-organized and able to work well in a fast-paced environment and under pressure
- Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices (e.g., CTD guidance, ICH guidelines)