Penfield Search Partners
Our client is a scientifically-driven leader in the development of Oncology therapies whose growing pipeline spans a variety of therapeutic approaches. They are currently seeking project-level Statisticians who, by providing statistical support, will be key contributors to drug development programs across a range of phases.
The Statistician will:
-
Provide statistical input to study protocols
-
Develop statistical analysis plans
-
Monitor internal and CRO project activities including timelines, deliverables and availability of resources
-
Interpret study results and write statistical summary reports of study results
-
Assist in writing relevant sections of the clinical study report
-
Participate and contribute to Clinical Development Plan
-
Participate in pre-IND and NDA activities
Desired for the role:
-
Ph.D. degree in statistics
-
1-5 years’ of industry experience
-
For the Sr. Manager position, a good understanding of FDA/EMEA guidelines and the drug development process is required
-
Demonstrated ability to work independently in project management and decision making
-
Previous experience in dealing with Health Authorities with regard to discussions/negotiations in filing strategies is highly desirable
-
Knowledge of multivariate analyses and Biomarker analyses is a plus