Statistical Lead

1 week ago

Nagpur Thane Mumbai, India beBeeBiostatistician Full time

Job Title: Statistical Lead

We are seeking a skilled Statistical Lead to join our organization. The ideal candidate will provide statistical support throughout the clinical trial lifecycle, from protocol development to the Clinical Study Report (CSR). This role involves preparing Statistical Analysis Plans, coordinating project activities, and serving as a key biostatistics representative on project teams.

Key Responsibilities
  • Support all assigned statistical tasks during the lifecycle of a clinical trial project, from protocol development to the CSR.
  • Prepare SAPs, including the development of well-presented mock-up displays for tables, listings, and figures.
  • Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work.
  • Review project work produced by other biostatisticians in the department.
  • Create or review programming specifications for analysis datasets, tables, listings, and figures.
  • Review SAS annotated case report forms (CRFs) and other study documentation to ensure all data is captured to support the planned analysis.
  • Conduct and participate in the verification and quality control of project deliverables.
  • Serve as the biostatistics representative on project teams, managing scheduling, time constraints, and proactively communicating any difficulties.
  • Monitor progress on study activities against milestones and ensure project timelines are met.
  • Provide statistical programming support as needed.
Required Skills and Qualifications
  • A graduate degree in biostatistics or a related discipline.
  • Proven experience in clinical trials.
  • Proficiency in programming.
  • Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.
  • Experience across all statistical tasks required to support clinical trials, from protocol to CSR.
  • Excellent written and verbal communication skills.
  • The ability to effectively communicate complex statistical concepts.

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