Senior Principal Biostatistician

9 - 11 years

14 - 19 Lacs

navi mumbai

Posted:1 day ago| Platform: Naukri logo

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Skills Required

biostatistics sas communication and interpersonal skills r statistics sas macros sas programming clinical sas programming regulatory requirements ich clinical research quality assurance regulations clinical trials base sas statistical programming

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibility
  • Develop and implement statistical analysis plans for clinical trials, ensuring compliance with regulatory requirements.
  • Collaborate with cross-functional teams to design and conduct statistical reviews of clinical trial protocols, informed consent forms, and case report forms.
  • Provide statistical input on study design, sample size calculations, and statistical methodologies.
  • Conduct statistical review of protocol deviations and ensure timely resolution.
  • Develop and maintain databases for tracking and managing statistical data from clinical trials.
  • Prepare and present reports on statistical findings and recommendations to stakeholders.
Job Requirements
  • Master's degree in statistics or related field; advanced degree preferred.
  • Minimum 5 years of experience in biostatistics, including experience working on Phase I-IV clinical trials.
  • Strong knowledge of statistical concepts, methods, and techniques, including statistical programming languages such as SAS or R.
  • Experience with clinical trial regulations, guidelines, and standards (e.g., GCP).
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Ability to prioritize tasks and manage multiple projects simultaneously in a fast-paced environment.

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Gratitude India Manpower Consultants Pvt. Ltd.

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