Senior Biostatistician (Early Clinical)

2 - 6 years

11 - 15 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Main responsibilities:
  • Support the clinical study design (including protocol development), the study setup and conduct.
  • Conduct the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
  • Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables)
  • Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
  • Contribute to define and review the specific deliverables related to Transparency and Disclosure
  • Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan.
  • Perform and/or coordinate with study programmer the production of statistical analyses.
  • Review and examine statistical data distributions/properties.

About you
  • Experience: Experience in pharmaceutical or related industry experience with clinical trials
  • Soft and technical skills: Demonstrated interpersonal and communication skills.
  • Good knowledge and good understanding of key statistical concepts and techniques
  • Basic knowledge of pharmaceutical clinical development
  • Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
  • Education: MS or PhD in Statistics or relevant fields
  • Languages: Good communication in English, both oral and written

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Sanofi logo
Sanofi

Pharmaceutical Manufacturing

Paris France

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