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.
