Date Posted: Thursday, 29th of April 2010
Salary: £Dependant Upon Experience
Start Date: ASAP
Telephone: 01438 870028
Location: EU
Discipline:Statistics
Consultant Name: Priya Mukherjee
Sector: Pharmaceutical
CK Clinical are pleased to be recruiting for an Associate Director of Biostatistics for a reputable Pharmaceutical company in the EU.
The purpose of the role is to provide statistical expertise to the clinical development program for assigned projects to ensure that scientifically valid conclusions are drawn concerning the company’s claims with respect to efficacy and safety of the compound under development, and to take full statistical responsibility for clinical development plans^and interactions with regulatory authorities.
Main Duties of the position include:
* Acting as a global project statistician for the company’s priority drug development projects;
* Taking full responsibility for statistical aspects of clinical development plans for assigned projects;
* Ensuring consistency in the entire program for an assigned project in terms of key variables, definitions, statistical methods, and presentation of results;
* Providing considerations for study objectives, designs, methods of clinical assessments and endpoints, statistical power, and statistical methods for the analysis of clinical data;
* Planning and performing integrated analyses of safety and efficacyas required for regulatory submissions or other purposes;
*Contributing to the detailed planning and efficient execution and reporting of clinical studies;
* Writing the statistical sections of the study protocol, and reviewing and signing off the final version;
* Preparing Requests for Proposals;
* Keeping up with all relevant developments in statistical and related methodologies, and regulatory guidelines and requirements
Interested applicants shouldhold an MSc/PhD (or Equivalent) in Statistics, with advanced knowledge of SAS/Base & SAS/Stat and a working knowledge of CDISC coupled with an understanding of the entire drug development process and in-depth familiarity with processes and procedures^in data management and SAS programming. You will also have proven experience of working within the Pharmaceutical industry together with proven experience of applying statistical methods in a research environment. You will have excellent written and^verbal communication skills with the ability to lead and direct a team of Biostatisticians, together with the ability to work independently and in a team. You will also have a keen eye for detail and excellent organisational and time management skills.
For a confidential discussion or further information, please contact Priya Mukherjee on 01438 870028 or email an updated CV to pmukherjee@ckclinical.co.uk for immediate consideration.
