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Job Details

Biostatistician Project Leader - Phase I - Office based in Frankfurt

Company: Umbilical Life
Location: Frankfurt
Reference: DAX/Frankfurt/Stat
Closing Date: 01 Jan 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Dax Kruczkowska of Umbilical Life is recruiting for a Biostatistician Project Leader, working with a Global pharma based in Frankfurt. You can expect attractive, market-oriented salary aligned with your qualifi¬cations and including social benefits above average (e.g. company pension plans, health manage¬ment).

Requirements:

Responsibilities:

  • 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
  • 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
  • Define, produce, review, and integrate reports on project safety, pharmacodynamics or efficacy.
  • Participate in meetings with regulatory authorities; prepare submission dossier
  • Make proposals to improve designs, analyses and, more broadly, the efficiency and effectiveness of the department through continuous bibliographic monitoring

Qualifications:

  • PhD or Master in mathematics / statistics, with specialization in Biostatistics
  • 8 years’ experience as a Statistician in the pharmaceutical industry with early clinical studies (up to and including Phase II); 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
  • Familiar with state of the art study designs and statistical methods
  • Very good skills in SAS; practice of R
  • Scientific and operational rigor
  • Autonomous in the management of your activities; organized, able to efficiently manage multiple and variable deadlines
  • 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

For a confidential discussion please contact Dax at Umbilical on +44 (0) 116 461 0070 or email dax@umbilical-life.com

Apply for this job: Biostatistician Project Leader - Phase I - Office based in Frankfurt

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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