Senior Principal Biostatistician

☞ Manpower

View: 122

Update day: 26-03-2024

Location: Morges Vaud VD

Category: R & D

Industry:

Job type: Temps plein, Durée indeterminée

Loading ...

Job content

General information

Company:Incyte Biosciences

Work area:Managers, All Other

Working time:Full-time

Country:Switzerland

City:Morges

Education:Master’s degree

Description

Job Status:Active

Description:

Summary

The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs.

Responsibilities

  • 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 required.

Required skills:

Requirmeents

  • Ph.D. degree in statistics preferred.
  • 5 to 8 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
  • Demonstrate 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.
Loading ...
Loading ...

Deadline: 10-05-2024

Click to apply for free candidate

Apply

Report job
Loading ...
Loading ...

SIMILAR JOBS

Loading ...
Loading ...