Posted to MedZilla on 8/19/2017


ProClinical

England, Senior Biostatistician SS_TS_13016-MZ


 
 

A Senior Biostatistician position has opened up at an international contract research organisation providing drug discovery, lifecycle management and laboratory services. With offices in over 45 countries and approximately 13,000 professionals, this company provide innovative ideas behind multiple sectors. This position will be based in London. The Biostatistician will act as lead statistician on projects of moderate to large size and complexity; support lead statistician on very large, complex studies. May have staff management and/or project management responsibilities. Write statistical reports. Aid in the development of protocols.

Job Overview:

  • Become familiar with the activities outlined in the department's Working Practice Documents and contribute changes as needed. Learn and follow departmental procedures for statistical analyses and programming work.
  • Serve as a lead statistician on large and complex projects
  • Lead a project team. This involves conducting team meetings, maintaining project timelines, assessing resource needs, providing resources, and budget preparation. Ensure that SOPs are being followed and that appropriate project documentation is ongoing.
  • Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Also contribute to writing appropriate protocol sections.
  • Provide randomization schemes and appropriate documentation.
  • Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming. Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation.
  • Write / review analysis plans and guide others on the team in its implementation. Define appropriate methods and procedures for statistical analysis.
  • Develop or supervise creation of table and listing specifications. Ensure that proper validation for statistical tables and listings is being implemented.
  • Perform statistical analysis for key efficacy endpoints.
  • Prepare reports, manuscripts, and other documents. Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
  • Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
  • Understand project budget as it relates to project work scope and communicate proactively with

Skills and Requirements:

  • MS/MA degree in statistics, biostatistics, mathematics or related field and two years’ experience required; or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities
  • Strong SAS programming skills and understanding of database structures.
  • Ability to promote teamwork in a multi-disciplinary team setting.
  • Strong knowledge of statistical principles and strong statistical skills.
  • Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments.
  • Evidence of strong management skills, as shown through management of multiple projects and/or staff members.
  • Excellent written and verbal communications skills.
  • Good organizational skills with the ability to adapt and adjust to changing priorities.
  • Positive attitude and the ability to work well with others.
  • PhD degree is desirable.
  • Two years of clinical trials experience preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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