Sr Statistician | Hyderabad
Syneos Health
India- IND-Hyderabad-Madhapur-Village
8d ago

PRIMARY FUNCTION :

Theposition is responsible for statistical methodology and statistical analysisplans for clinical projects, and acts as the project statistician on complextrials and across multiple studies.

MAJOR RESPONSIBILITIES :

  • Act as the core project team lead to coordinate and manage all statistical project activities
  • Providing statistical liaison with the client and input for protocol and CRF development
  • Prepare statistical analysis plan
  • Perform validation and statistical quality checks on computer-generated output to verify accuracy.
  • Prepare or review key portions of the integrated clinical / statistical report, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy and safety results.
  • Attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
  • Following departmental SOPs, OGs and relevant regulatory guidelines (e.g. ICH).
  • SKILLS REQUIRED

  • M.Sc Stats / M.Phil / Ph.D
  • Min 6 years’ experience with drug development or related statistical analysis
  • Experience with the use of statistical methodology appliedto clinical trials
  • Proficiency in SAS programming
  • Proven ability to meet deadlines
  • Excellent communication, presentation,interpersonal skills, both written and spoken, with an ability to inform,influence, convince, and persuade
  • Apply
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