Data Insights Specialist

20 hours ago

Vijayawada, Andhra Pradesh, India beBeeBiostatistician Full time ₹ 15,00,000 - ₹ 20,00,000
Job Description

As a Senior Biostatistician, you will lead the development and implementation of statistical strategies in support of clinical trials. This role involves planning, execution, and interpretation of statistical analyses across development programs.

You will contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation. Your responsibilities will include authoring and reviewing Statistical Analysis Plans (SAPs), ensuring the execution of statistical analyses per SAP, and providing statistical leadership in vendor oversight.

You will also regularly communicate project status to management and escalate issues or risks in a timely manner. Additionally, you will provide statistical input and review for clinical study reports, regulatory documents, and publications.

Required Skills and Qualifications

  • A Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field is 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 is essential, with knowledge of R and other programming languages being preferred.
  • Solid knowledge of statistical methodologies and clinical trial designs is required.
  • Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application is necessary.
  • Experience with regulatory support and interaction is essential.
  • Experience providing statistical oversight of vendors and managing CRO collaborations is required.
  • Proven ability to manage multiple studies and timelines concurrently is essential.
  • Excellent verbal and written communication skills, with the ability to explain statistical concepts to non-statisticians, are necessary.

Benefits

  • The opportunity to work on complex clinical trials and develop your expertise in statistical analysis.
  • The chance to collaborate with cross-functional teams and contribute to the success of the organization.
  • A competitive salary and benefits package.

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