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Job Id 18101
Title Principal BioStatistician
Job Type Permanent
State West Bengal
Job Description MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.

  • Preparation and Review of Statistical Analysis Plan (SAP)
  • Preparation and Review of Mock Tables, Listings and Figures (TLFs)
  • Preparation and Review of Statistical Analysis Report (SAR)
  • Involve in statistical review of final deliverables to the client
  • Involve in planning and design of the study
  • Preparation and Review of inputs for the protocol development including sample size calculation and randomization
  • Preparation and Review of Biostat quote preparation for proposed studies
  • Review of Case Report Form (CRF)
  • Preparation of critical data points for CDM team
  • Preparation and Review of programming specifications for Analysis datasets creation
  • Review of Clinical Study Report (CSR)
  • Any other responsibilities assigned by the Director - Biostatistics as and when need arises
  • Maintain 100% Quality and on time delivery of above activities

  • Acquire up to date information about statistical software updates and knowledge of statistical methods and techniques in SAS programming. Get trained in current data standards, templates and guidelines in regulatory submissions. Periodically updating CDISC skills through guidelines. It is expected that the post holder will perform duties without direct supervision and will be self directed in terms of time and workload management.
  • Professional
  • Good knowledge in statistical concepts, methodology and SAS programming.
  • Minimum 6-12 years experience in a pharma / CRO is essential

Leadership & Management
  • Strong interpersonal and communication skills
  • Expertise in strong database management skills and computer applications
  • Strong writing skills
  • Ready to work in a team
  • Take lead role to complete the statistical activities including SAS programming for the assigned studies

  • Masters degree in Statistics / Biostatistics is essential
  • Knowledge in SAS programming is desirable

  • Interest in statistical methods, clinical research, drug development and CDISC activities
  • Strong desire to learn new techniques in SAS and statistics

Experience 8-12yrs
Job Category Biostatistician
Posted On 1/28/2019
Expires On 3/28/2019
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