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Job Details

Principal Statistician – UK – Home/office based flexibility - Permanent position

Company: Clintec
Location:
Reference: UK-PS-280218-MC
Closing Date: 23 May 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Clintec is actively recruiting for a Principal Statistician to join our expanding global company.  By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. In the past 12 months, we have expanded into 17 new countries with offices opening across the globe. Apply now and become part of our international team.

Requirements:

Principal Statistician – UK – Home/office based flexibility - Permanent position

 

Clintec is actively recruiting for a Principal Statistician to join our expanding global company.  By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. In the past 12 months, we have expanded into 17 new countries with offices opening across the globe. Apply now and become part of our international team.

 

Job Description

Working as a Principal Statistician for Clintec you will be responsible for the coordination and contribution to all biostatistics activity within the Biostatistics and Programming department. You will ensure by co-ordination of biostatistics activities, that projects are completed on or ahead of time, according to the requirements of the contract with the Sponsor and according to the quality standards defined by appropriate procedures.

Key Accountabilities

  • Works with project team to decide on appropriate study design for routine designs and responsible for protocol review. Assists in the implementation of protocol methodology.
  • Assists in the development and implementation of the statistical methods section of protocol.
  • Assists in the development of randomization schedule, sample size and power calculations
  • Responsible for assuring that data for statistical analyses are accurate. Assists in the development of alternative analysis strategies when changes to planned analyses are needed.
  • Responsible for accuracy of statistical tables and data listings, and accuracy of report text. Identify and correct flaws in interpretation of results, inconsistency in presentation or inference.
  • Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines.
  • Interact with data management personnel as necessary to ensure that datasets are in usable format; perform statistical diagnostics prior to database locking.
  • Interact with SAS Programmers to ensure that appropriate programs are being developed for current clinical studies.
  • Perform statistical quality assurance review and program validation for each project.
  • Interact with medical writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information. Review statistical sections of draft documents.
  • Interact with other departments, such as clinical operations and project management, to ensure a high level of client satisfaction through successful execution of projects.

Essential Criteria:

  • 7+ years’ experience in a CRO and/or Pharma preferably with at least 2 years at a CRO
  • Masters in Statistics or within similar field
  • Experience in creating Statistical Analysis Plans for registration studies
  • Oversight of Data Safety Monitoring Committee activities
  • Experience with regulatory submissions and meetings with regulatory bodies such as the FDA 
  • Significant SAS and SDTM/ADaM Programming experience
  • Good knowledge of the clinical trial process.
  • Strong organisational and communication skills.

 

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package. 

Apply for this job: Principal Statistician – UK – Home/office based flexibility - Permanent position

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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