Bengaluru, Karnataka, India; Chandigarh, Punjab, India; Hyderabad, Telangana, India; Mumbai, Maharashtra, India; SAS Nagar (Mohali), Punjab, India
Minimum requirements:
Master’s degree in Statistics or equivalent & ≥ 6 years of industry related experience
Or
Ph.D. in Statistics or equivalent & ≥ 4 years of industry related experience
Must Have
• Ability to work successfully within a global cross-functional teams leading to successful regulatory filings and approvals
• Excellent verbal and written communications skills.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.
• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.
Responsibilities:
• Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
• Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
• Translates scientific questions into statistical terms and statistical concepts into layman terms
• Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
• Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
• Communicates effectively with clinical and regulatory partners and external opinion leaders
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
• Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
• Compliant with client processes and SOPs, global and project standards, and responsible for quality of deliverables
• Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
Apply here: https://jobs.parexel.com/en/job/remote/senior-biostatistician/877/66337300880