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Senior Biostatistician

  • Job type: Permanent
  • Location: Basel
  • Salary: Competitive
  • Job reference: RTGM
  • Sector: Biostatistics, EPM Scientific, Pharmacology
  • Date posted: 07/08/2017
 Senior Biostatistician  
  • Senior Biostatistician 
  • Switzerland, France, Belgium
 
EPM Scientific is currently seeking a Senior Biostatistician, for a top 10 global Pharmaceutical company. This world renowned organisation primarily focusses on oncology, neurology and cardiology, and is seeking to expand their Biostatistics and Clinical Data Management teams following a strong period of growth. This opportunity comes with the choice of remote or office based employment – allowing the individual greater flexibility in their work-life balance.


Key responsibilities include:


The Senior Biostatistician works under the supervision of the Biostatistics project lead (BPL), and is responsible for the design, development and evaluation of the technical/statistical infrastructure for the conduct and evaluation of clinical trials, including the coordination of all related areas/activities.


  • Developing the statistical section of the study protocol and any necessary amendments, including performing exploratory analyses of past studies and reviewing of relevant literature for optimal sample size estimation
  • Preparing and overseeing the development of the randomization plan and documentation
  • Developing the statistical analysis plan (SAP) and corresponding TFL shells (in-text and end-of-text) with TFL programming notes in support of IA, DMC, and CSR analyses
  • Developing cross-functional data review (XFDR) plan and leading blinded XFD reviews
  • Providing input to protocol deviation plan development and review
  • Providing input to SDTM/CDISC and ADaM programming specifications development and review, (e-)CRFs, data monitoring plan, data management plan and data validation plan development
  • Serving as a key contributing member of project teams with other Study Execution Team (SET) functions responsible for meeting study objectives
 
Ideal candidates will be able to demonstrate the following:
  • Master and/or Doctoral degree in Statistics or Mathematics, or equivalent
  • Thorough knowledge of processing clinical trial information, the drug development process, statistical methodology, GCP and regulatory guidelines
  • At least three years of experience working as a trial and project statistician in clinical development or equivalent
  • Ability to communicate statistical information to non-statisticians.
  • PSTAT with focus on TMCP: Subject matter knowledge of pharmacokinetic data as well as the different types of biomarker and related technologies/assays for measurement.
  • Excellent communication and presentation skills to interact with authorities and external bodies (specialists as well as non-specialists) on statistical-methodological issues.
  • Good project management skills.
  • Fluency in written and spoken English.
If interested, please send us a copy of your CV for shortlisting, at your earliest possible convenience,




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