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Principal Biostatistician

2 weeks ago

Bengaluru, India Veranex, Inc. Full time

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
- Minimum Requirement:

- Master’s degree or international equivalent and 8+ years of relevant work experience; PhD or international equivalent and 5+ years of relevant work experience
- Master’s degree or PhD or international equivalent in statistics, applied statistics or biostatistics
- In-depth knowledge of ICH GCP guidelines
- Advanced knowledge of creation and review of safety and efficacy data analysis
- Advanced knowledge of relevant Data Standards
- Advanced knowledge of the SAS computing package
- Thorough understanding of statistical analysis plan (SAP) and mock shell creation and review
- Thorough understanding of statistical issues in clinical trials
- Excellent written and oral communication skills including conflict management and the ability to negotiate
- Excellent attention to detail
- Advanced analytical skills and ability to prioritize
- Advanced ability to plan, supervise, implement, and monitor the statistical processes for clinical studies
- Ability to solve complex problems
- Advanced ability to effectively manage multiple tasks and projects
- Ability to lead and coordinate small teams
- Roles and Responsibilities:

- Leads the production, review, and quality control of statistical deliverables.
- Performs sample-size calculations, generates randomization lists and writes statistical methodology sections for study protocols.
- Provides broad statistical support, including protocol development and trial design.
- Reviews statistical analysis plans, derived datasets, tables, listings, and figures.
- Reviews protocol to ensure statistical integrity and optimal study design.
- Coordinates and leads project team. Interacts with clients as key statistical contact.
- Trains and mentors new or junior statisticians on statistical methods.
- Participates in business development activities by providing input to Request for Proposals.
- Provides input into and reviews CSR and other summary reports.
- Prepares or reviews Statistical Analysis Report (SAR).
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside area of expertise.
- Having wide-ranging experience, uses professional concepts to resolve complex issues in creative and effective ways
- Determines methods and procedures for new assignments and may coordinate activities of other team members.