Advanced Quantitative Analyst

6 days ago

Shimoga, Karnataka, India beBeeBiostatistician Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Biostatistician Position

The Senior Biostatistician plays a pivotal role in leading the development, implementation, and oversight of statistical strategies to support clinical trials. Under the guidance of the Head of Biostatistics, this position contributes to the planning, execution, and interpretation of statistical analyses across development programs.

Key Responsibilities:
  • Lead biostatistics efforts for assigned studies and projects, ensuring seamless integration with cross-functional teams.
  • Participate in study design discussions, including protocol development and endpoint definition, applying expert knowledge of CDISC standards (e.g., SDTM, ADaM).
  • Author and review Statistical Analysis Plans (SAPs), including mock tables and figures, to ensure high-quality deliverables.
  • Oversee statistical programming activities and manage project timelines, collaborating closely with vendors.
  • Provide statistical leadership in vendor oversight and communicate project status to stakeholders.
Requirements:
  • A Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field, complemented by a minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 6 years for PhD-level candidates.
  • Proficiency in statistical programming in SAS and knowledge of R and other programming languages, enabling efficient data analysis.
  • Solid understanding of CDISC standards and their application, facilitating collaboration with regulatory agencies.
  • Experience with regulatory support and interaction, ensuring compliance with industry regulations.
Skills and Abilities:
  • Strong analytical and problem-solving skills, combined with excellent verbal and written communication skills, to effectively convey complex ideas.
  • Ability to work collaboratively as part of a team, contributing to cross-functional initiatives and driving results-oriented outcomes.
  • Demonstrated ability to communicate statistical concepts and results clearly and effectively, both verbally and in writing.

Benefits include opportunities for professional growth and development within a dynamic organization.

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