Senior/Principal Biostatistician or Manager, Biostatistics

Location
Wilmington, Delaware
Posted
Aug 21, 2018
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Summary: 

The Principal Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.

Essential Functions of the Job:            

  • Interact with members of the multidisciplinary project teams to establish project timelines.
  • Provide statistical input to study protocols.
  • Write statistical analysis plans.
  • Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
  • Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
  • Interpret study results and provide review of statistical summary reports of study results for accuracy.
  • Assist in writing relevant sections of the clinical study report.
  • Participate and contribute to authoring of Clinical Development Plan.
  • Participate in pre-IND and NDA activities.
  • Participate in the development and enforcement of SOPs and guidelines.
  • Other responsibilities, as necessary.
  • Interact with members of the multidisciplinary project teams to establish project timelines.
  • Provide statistical input to study protocols.
  • Write statistical analysis plans.
  • Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
  • Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
  • Interpret study results and provide review of statistical summary reports of study results for accuracy.
  • Assist in writing relevant sections of the clinical study report.
  • Participate and contribute to authoring of Clinical Development Plan.
  • Participate in pre-IND and NDA activities.
  • Participate in the development and enforcement of SOPs and guidelines.
  • Other responsibilities, as necessary.

Qualifications:      

  •  Ph.D. degree in statistics.
  • 0 to 6 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
  • Demonstrated ability to work independently in project management and decision making.
  • Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
  • Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
  • Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
  • Knowledge of multivariate analyses and Biomarker analyses is a plus.