Penfield Search Partners
Senior Biostatistician to Associate Director, Biostatistics
Location: Seattle, WA or SSF, CA
Contact Susan Devine – email@example.com
Our client is a leader in the development of antibody-drug conjugates to treat cancer. Currently they are seeking several Biostatisticians to play key roles in the advancement of their robust Oncology pipeline. These are hands-on positions; depending on level you may have full compound responsibility for at least one asset and management responsibility to include 3-5 reports. In this smaller organization you will play an integral part on cross-functional drug development teams and will have the opportunity to engage stakeholders at the top level of the organization. Modern thinking and innovative approaches are highly regarded in this organization so as part of these roles you will have the opportunity to apply and develop the most up-to-date statistical methods and designs. These roles can be filled at varying levels.
- Provide statistical expertise on clinical development, ranging from proof-of-concept trials to regulatory filings and post-marketing studies
- Manage and mentor Biostatisticians
- Collaborate with clinical colleagues in developing innovative trial designs, & apply scientific rigor to methods of analysis and interpretation of results
- Provide statistically sound experimental design and data analysis input to meet project objectives and regulatory requirements; run simulations to assess operating characteristics of designs; develop ad hoc analysis plans
- Support regulatory strategies by providing statistical leadership to product development plans
- Represent company both internally and externally
- Define resourcing needs
Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
Desired for the role:
- PhD in Statistics/Biostatistics or related field with 6+ years of relevant experience.
- Oncology development experience is required.
- Previous experience providing leadership to biometrics staff is preferred.
- Experience with Bayesian methods is ideal.
- The ability to explain technical issues effectively to technical and non-technical staff is key here, as is a sound understanding of ICH guidelines and FDA requirements.
- The company is passionate about creating opportunities for intellectual curiosity and professional growth and values strong analytical and problem-solving skills.