Global Pharmaceutical Company
Associate Director/ Director, Biostatistics
Location: Anywhere on the East Coast
Salary: $185,000 - $240,000 + bonus + excellent benefits + relocation
A Top Global Pharmaceutical Company is looking to hire an Associate Director/ Director of Biostatistics to their team. This is a growth hire due to recent funding and expansion plans. This person will report to the VP of Data Science and will work with crossโfunctional teams as the project biostatistician for one or more programs.
Responsibilities:
- Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
- Perform sample size calculations, develop statistical analysis plans and lead TLF development
- Develop, implement, and improve statistical processes and standards
- Interact with global regulatory authorities
- Represent statistics in cross-functional project and study teams in multiple projects
- Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
- Perform statistical analyses and validate analysis
- Support and participate in the development of departmental strategies
Requirements:
- Ph.D. or Master's degree in Statistics, Biostatistics or a related field
- 8-12 years in the pharmaceutical industry/ CRO including submission experience
- Knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
Benefits:
- Medical, Dental and Vision Insurance
- Relocation package (If applicable)
- Free on-site gym access
- 401(K) plan with significant company match
- Unlimited sick time
- Discounted auto and home insurance
- And moreโฆ