Lead Statistical Expert

1 week ago

Anantapur, Andhra Pradesh, India beBeeBiostatistician Full time ₹ 15,05,600 - ₹ 23,31,800
Senior Biostatistician Job Description

The Senior Biostatistician plays a vital role in advancing clinical drug development processes. This position leads, develops, implements, and oversees statistical strategies and deliverables to support sponsored clinical trials.

Key Responsibilities:
  • Leads biostatistics efforts for assigned studies and projects, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.
  • Contributes to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • AUTHORS AND REVIEWS STATISTICAL ANALYSIS PLANS (SAPS), INCLUDING MOCK TABLES, FIGURES, AND LISTINGS (TFLs).
  • Oversees the execution of statistical analyses per SAP in collaboration with programming and CRO partners.
  • Provides statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables.
  • Regularly communicates project status to management and escalates issues or risks in a timely manner.
  • Provides statistical input and review for clinical study reports, regulatory documents, and publications.
  • PERFORMS QUALITY CONTROL (QC) OF STATISTICAL OUTPUTS TO ENSURE ACCURACY AND COMPLIANCE WITH INTERNAL STANDARDS.
  • Leads or supports regulatory interactions on statistical issues and provides applicable statistical strategies to handle clinical and regulatory considerations.
  • DELIVERS STATISTICAL PRESENTATIONS TO INTERNAL AND EXTERNAL STAKEHOLDERS, OR REGULATORY AUTHORITIES AS NEEDED.
  • Contributes to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines.
Required Skills and Qualifications:
  • Masters degree or PhD in Biostatistics, Statistics, or related quantitative field required.
  • 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. Knowledge of R and other programming languages 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 timelines concurrently.
  • Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians.
  • Ability to work as a team and have skills to convince your position within cross-functional teams.
  • Demonstrated ability to communicate statistical concepts and results clearly and effectively.
  • Interest in and ability to learn clinical drug development processes.
  • Able to work independently with minimum supervision.

 

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