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Principal Biostatistician
Veranex
posted 1y ago
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Flexible timing
Key skills for the job
Job Description
- Masters degree or international equivalent and 8+ years of relevant work experience; PhD or international equivalent and 5+ years of relevant work experience
- Masters degree or PhD or international equivalent in statistics, applied statistics or biostatistics
- In-depth knowledge of ICH GCP guidelines
- In-depth knowledge of moderately complex statistical methods that apply to clinical trials
- 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.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
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