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Job Details

Biostatistician Project Leader – Office Based – South Of France

Company: Umbilical Life
Location:
Reference: BPL-OB-ROBERTS
Closing Date: 10 Jun 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Gabriel Roberts of Umbilical Life is looking to recruit a Biostatistician Project Leader to work for a global company based in the South Of France.

Requirements:

Responsibilities:

  • In collaboration with the members of the project team in an international context (eg, clinical, pharmacovigilance, regulatory affairs, marketing), contribute to the elaboration of the early development strategy, participate in the management of the project, take part in the preparation of the associated submission dossier, provide quantitative elements for decision-making.
  • In interaction with the therapeutic units, carry out the project by acting as statistician of a study and/or coordinating the statisticians in charge of the different studies from the protocol to the study report.
  • Appropriately integrate the translational approach strategy into development plans and implement it
  • Actively participate in writing clinical study synopsis/protocols, interpreting statistical analyses, and presenting results
  • Review or produce the Statistical Analysis Plans and the statistical part of the study reports

 

Qualifications:

  • PhD or Master in mathematics /statistics, with specialization in Biostatistics.
  • Statistician with significant experience in the pharmaceutical industry (> 8 years) in the field of early clinical studies (up to and including Phase II), with experience as a biostatistics project manager. Experience in biomarker development, Phase IIb/III and submission would be appreciated.
  • High proficiency of clinical research and business strategy in this field; mastery of general regulatory guidelines, and specific to at least one therapeutic area
  • Ability to understand clinical, regulatory and marketing issues and propose innovative/state-of-the art development plans, trial designs and analyses
  • High proficiency of statistics used in the pharmaceutical industry in clinical development including statistical methods used for flexible designs as well as simulation technics; modelling and biomarker data mining skills
  • Successful experience as a project manager; strong capacity for anticipation, organization and coordination; leadership, including supervision of contractors; ability to work as a team player and interact with all stakeholders.
  • Familiar with state of the art study designs and statistical methods
  • Very good communication skills and good popularization skills for explaining the statistical methods used.

Benefits:

A competitive salary.

 

For a confidential discussion please contact Gabriel Roberts at Umbilical

on +44 (0) 116 461 0070 or email Gabriel@umbilical-life.com

Apply for this job: Biostatistician Project Leader  – Office Based – South Of France

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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