87 days ago on jobs.celgene.com

Principal Statistician

Celgene Switzerland SA

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Principal Statistician

Principal Statistician

Req #:16000896
Job Category:Clinical Operations
Work Location:Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization:Celgene R&D Sarl
Shift:Day Job
Employee Status:Regular
Job Type: Standard
Job Level: Manager


Responsibilities will include, but are not limited to, the following:

1. Actively provide statistical support to the Clinical R&D Department.

  •  Provide statistical input into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs that are acceptable by regulators.
  •  Prepare statistical analysis plans including table shells.
  •  Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc/data driven analyses.
  •  Provide statistical input for the preparation of final study reports and other required documents.
  •  Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
  •  Contribute to Clinical Development Plan.
  •  Support preparation of manuscripts.
  •  Provide project requirements to programmers.
  •  Serve as statistical lead on studies, projects, NDAs or sNDAs.

2. Represent Celgene in interfaces with regulatory agencies globally.

3. Provide statistical input to senior management.

4. Manage outside CROs and consultants as needed.

5. Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.

6. Provides leadership

  •  Sought out statistical expert to peers and others
  •  Provides supportive feedback to peers and leaders
  •  Proactively seeks ways to gain broader experience/perspectives and make contributions
  •  Participates in cross-functional collaboration and meetings to gain the trust and respect of members, make decisions on business issues and freely challenges and expresses opinions
  •  May provide coaching and mentoring and provides feedback via formal/informal appraisals





 Ph.D. or MS in statistics with a focus on statistical methods appropriate for clinical trials.

 Experience in clinical drug development of at least 5 years for Ph.D. and 7 years for MS.

 Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.

 Demonstrated skill in the planning, analysis and reporting of clinical trials. .

 Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.

 Excellent SAS skills.. Willingness to be hands-on when needed.

 Knowledge of MS Office products (Word, Excel, PowerPoint)

 Good interpersonal, communication, writing and organizational skills.

 Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.