Lead Statistical Strategist

2 weeks ago

Davangere, Karnataka, India beBeeBiostatistician Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Biostatistician Role Overview

The Senior Biostatistician is a key professional responsible for leading and developing statistical strategies and deliverables to support clinical trials. This role contributes to planning, execution, and interpretation of statistical analyses across development programs.

Main Responsibilities
  • Serves as biostatistics leader for assigned studies and projects, providing strategic direction and oversight to ensure successful outcomes.
  • Leads study design discussions, including protocol development and endpoint definition, ensuring that trials are designed to meet regulatory requirements and maximize data quality.
  • Authors and reviews Statistical Analysis Plans (SAPs) to ensure accuracy and compliance with regulatory standards.
  • Oversees statistical programming activities and manages deliverables, guaranteeing timely completion and high-quality results.
  • Communicates project status to management and escalates issues or risks, promoting transparency and collaboration across teams.
  • Provides statistical input and review for clinical study reports and publications, ensuring the integrity and validity of data presented.
Essential Qualifications
  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field, with a strong foundation in statistical theory and practice.
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 6 years for PhD-level candidates, with a proven track record of success in leading and delivering complex projects.
  • Proficiency in SAS statistical programming and knowledge of R, with the ability to write efficient and effective code.
  • Strong understanding of CDISC standards and their application, ensuring seamless data exchange and integration.
Preferred Attributes
  • Experience with regulatory support and interaction, including preparation of submissions and responses to agency queries.
  • Proven ability to manage multiple studies and timelines concurrently, prioritizing tasks and resources to meet deadlines and objectives.
  • Excellent verbal and written communication skills, with the ability to articulate complex technical concepts to both technical and non-technical stakeholders.

Minimum Education: Master's degree or PhD in Biostatistics, Statistics, or related quantitative field.

Minimum Experience: 8 years of experience in clinical trial biostatistics for MS-level candidates; 6 years for PhD-level candidates.

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