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Statistician/Biostatistician

Company: TCS


Role: Statistician/Biostatistician


Domain: Life Science


Work Location: Mumbai/Bangalore/Pune/Chennai


Must have skills:

  • PhD (Statistics) with 3+ years relevant experience (OR) MSc (Statistics ) with 5+ years relevant experience in the design, execution, analysis and interpretation of clinical trials.
  • Experience in SAS and/or R 
  • Experience in multiple therapeutic areas and across multiple phases of clinical trials 
  • Experience in writing Statistical Analysis Plan including mock TLF’s, providing input to study documents like protocol, CRF, database designing and CSR 
  • Experience in advance statistical techniques and sample size calculation 
  • Experience in writing statistical report 
  • Ability to work independently with least/no supervision & work effectively in a team environment.


Good to have skills:

  • Experience with modeling and simulation, and other innovative methodologies
  • Evidence of statistical innovation and technical statistical strength in clinical trial domain
  • Experience in submissions and interacting with regulatory bodies.
  • Strong time management skills; able to effectively organize and manage a variety of tasks across different projects


Key responsibilities:

  • Provide statistical input to protocol or review the protocol 
  • Develop/ review Statistical Analysis Plan (SAP)
  •  Review case report form (CRF) and data specifications
  • Review of statistical and clinical study report
  •  Assist SAS programmers and junior biostatisticians on complex statistical methods and corresponding SAS procedures
  • Maintain quality and timeliness of assigned project work.
  •  Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions.
  • Ensure compliance with SOPs and project specific guidelines.
  • Mentor junior biostatistician.
  • Must work on multiple tasks simultaneously and meet project deadlines under stringent timelines
  • Act as client key contact and be responsible for project deliverables for projects as assigned
  • Provide input to process improvements
  • Communicate with clients effectively
  • Communicate with other departments and/or groups effectively

 

Interested candidates can share their CV to ankita.yelve@tcs.com




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