Clinical Data Analyst Manager

6 days ago

Vizag, Andhra Pradesh, India beBeeBiostatistician Full time ₹ 15,00,000 - ₹ 27,00,000
Lead Clinical Biostatistician

We are seeking an experienced Lead Clinical Biostatistician to play a critical role in developing, implementing, and overseeing statistical strategies for sponsored clinical trials. This position involves leading biostatistics teams, contributing to study design discussions, authoring statistical analysis plans, and providing statistical leadership in vendor oversight.

The successful candidate will have a strong understanding of CDISC standards, experience with regulatory support, and the ability to manage multiple studies concurrently. They will also possess excellent verbal and written communication skills, with the ability to explain complex statistical concepts to non-statisticians.

  • Key Responsibilities:
  • Lead biostatistics teams and contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings.
  • Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables.
  • Regularly communicate project status to management and escalate issues or risks in a timely manner.
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications.
  • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
  • Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations.
  • Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed.
Requirements
  • Masters degree or PhD in Biostatistics, Statistics or related quantitative field, required.
  • Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates.
  • Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred.
  • Solid knowledge of statistical methodologies and clinical trial designs.
  • Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application.
  • Experience with regulatory support and interaction.
  • Experience providing statistical oversight of vendors and managing CRO collaborations.
  • Proven ability to manage multiple studies and timeline concurrently.
  • Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians.
  • Able to work independently with minimum supervision.

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