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Title:Senior Biostatistician
Salary:Open
Experience:5
Location:NJ - East Hanover

Description:
The Senior Statistician is responsible for all statistical tasks of individual clinical trials. He/she may take on project level tasks of a Program Statistician, initially under the supervision of a more experienced Statistician/Group Head but with increasing autonomy and accountability.

Responsibilities:
  • Be responsible for all statistical tasks with a high level of independence e.g. clinical trail design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase.
  • May be assigned to lead a small project or parts (e.g. indication) of a project, initially under the guidance of a more experienced statistician, but with increasing autonomy and accountability.
  • Track clinical trial/allocated project activities and milestones.
  • Ensure timeliness and adequate quality of all B&SR deliverables for the assigned trials and project tasks.
  • Follow processes and adhere to company and project specific standards as well as Health Authority requirements (SOP's, NIP's, Master Analysis Plan, GCP and regulatory guidelines).
  • Participate in or lead non clinical activities as needed. S&SR team.
  • Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/International Clinical Trial Team and the B&SR team

Requirements:
  • At least Masters Degree in Statistics or equivalent degree with five years of experience or PhD with 2-3 years of experience.
  • Fluent English (oral or written).
  • Experience in all tasks of a Trial Statistician.
  • Proven knowledge in Statistics and its applications to clinical trials.
  • Proven knowledge of drug development and HA guidelines. Background medical knowledge preferably in relation to the specific therapeutic area.
  • Proven knowledge of statistical software packages.
  • Good communication and presentation skills.
  • Good team player.

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