Biostatistics Team Leader - Phase I

Recruiter
Umbilical Life
Location
Bedfordshire
Posted
18 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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 James Carrera at Umbilical +44 (0) 116 461 0074 or james.carrera@umbilical-life.com

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