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Statistician

Job type:
Contract
Sector:
Life Sciences
Location:
Germany
Salary:
Negotiable
Date posted:
19/05/2017
Job reference:
BBBH7107_1495209950
This vacancy has now expired.

PRINICPAL STATISTICAL PROGRAMMER - BIOSTATISTICS & CLINICAL PROGRAMMING - Germany

12 Month Contract

Subject Matter expert required for the position of Principal Statistical Programmer for a leading CRO to be based in the South of Germany, extensive knowledge and experience in this field is required so as to have the capability to provide expert technical support and advice to the internal and external sponsors of the CRO. Broad understanding of Clinical programing is required as assistance will be essential throughout all spheres of own department and various other departments, including; coordinating projects, liaising with sponsors, lead the data operations, monitor quality, timelines, resource allocation and productivity in relation to budgets. Successful applicant will have responsibilities in a number of areas throughout the Company which would involve the Production/ Quality Control derived datasets, statistical tables, listing and figures, candidate will also be involved in the import or export of programming specific to Quality Control specification development and mapping these specifications to support relevant data standards. Strong Project Management will prove beneficial in this position as key responsibilities will apply to various aspects of Principal Statistical Programmer duties and expectations. As this position is for an International CRO who extensively work throughout a number of International settings- previous working experiences and knowledge of International regulatory requirements is essential.

REQUIREMENTS:

  • Coordinate SAS Programming role in various projects, input and negotiate timelines
  • Delegate certain tasks and manage team to successfully complete study within given timelines and budgets
  • Ensure that quality control on all processes and technical activities related to derived dataset, table, listing, and figure programming in accordance with company SOPs and at an international regulatory standard
  • Maintain all supporting documents in accordance with WSOPs
  • Strong Leadership skills to lead and participate in process or quality improvement initiatives- ensure that good relationships are built with QMG groups
  • Maintain and expand local and international regulatory knowledge within the clinical industry
  • Provide good leadership and influencing capabilities to achieve business objectives
  • Ensure that Quality Management groups comply with WSOPs

RESPONSIBILITIES:

  • Maintain and expand existing international regulatory knowledge
  • Lead and support teams to reach the objectives set out by the CRO, including technical knowledge and expertise
  • Provide consultancy to internal and external sponsors with regard to statistical programming tasks, maintain visibility and open communications to ensure expectations of sponsors are met
  • Oversee and guide multiple-trial programs, complex trials and submission projects
  • Assist in the production and QC of analysis plans, produce and QC TLF mock shells, derived dataset specifications, programming specifications and other process supporting documents
  • Have a good knowledge and background of programming techniques to produce QC derives datasets, figures and data listings

THIS IS A COMPETITIVE POSITION AND ONE THAT REQUIRES IMMEDIATE APPLICATION. IF YOU ARE KEEN TO PURSUE THIS POSITION, PLEASE DO SEND ME YOUR MOST RELVANT CV AS WELL AS THE BEST POSSIBLE NUMBER TO REACH YOU.

 

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