Lead Statistician for Clinical Trials

3 days ago

Malappuram, Kerala, India beBeeBiostatistician Full time ₹ 1,81,10,000 - ₹ 2,51,10,000
Job Title: Senior Biostatistician

The primary goal of this position is to provide high-quality statistical expertise and support to clinical trials. This will involve collaborating with cross-functional teams, including Biostatisticians, Statistical Programmers, Clinical Data Managers, and Clinical Research Associates.

The Senior Statistician will be responsible for performing and overseeing quality control (QC) of data displays with inferential statistics, as well as conducting QC analysis on datasets prepared by others. Additionally, they will maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and tracking logs.

Responsibilities:
  • Collaborate with cross-functional teams to provide statistical support to clinical trials.
  • Perform and oversee quality control (QC) of data displays with inferential statistics.
  • Conduct QC analysis on datasets prepared by others.
  • Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and tracking logs.
Requirements:
  • Master's degree in statistics or a related field with 6+ years of industry experience as a Statistician.
  • PhD degree with 3+ years of postgraduate experience in Biostatistics or equivalent.
  • Solid statistics background and training, working knowledge of advanced statistical methodologies, and SAS programming skills.
  • Good understanding of drug development and experiences with clinical trial data analyses/preparation for submissions.
  • Good knowledge and understanding of regulatory guidelines.

This position requires a strong leader who can effectively manage team members and work collaboratively in diverse organization structures. The ideal candidate will have excellent communication and problem-solving skills, as well as the ability to adapt to changing priorities and deadlines.

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