Lead Biostatistician

remote from anywhere in India

Full-time

Job Overview

The Lead Biostatistician is responsible for the overall statistical management of services for projects to assure high quality and on-time delivery in accordance with Atorus and / or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. Provides leadership and statistical expertise into clinical development plans, concepts, and protocols as well as conducts statistical analysis and validates and interprets statistical analysis results.

Job Responsibilities

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent company and the statistical team on the Product Development Teams of sponsors. Provide oversight of statistical analysis plans, statistical outputs, and other documents as required.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• Manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her / his expertise and customer orientation.
• Contribute to the development of sourcing strategy for projects.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Qualifications And Education Requirements

Preferred Skills

Skills Required

R Programming, Statistical Analysis, Sas