Must have 5 - 8 years of relevant experience in Biostatistics
Masters degree or international equivalent in statistics, applied statistics or biostatistics
Strong oral and written communication skills and interpersonal skills.
Strong knowledge of ICH GCP guidelines
In-depth knowledge of moderately complex statistical methods that apply to clinical trials
Strong knowledge of creation and review of safety and efficacy data analysis
In-depth knowledge of relevant Data Standards
Strong knowledge of the SAS computing package
Strong understanding of statistical analysis plan (SAP) and mock shell creation and review
Strong written and oral communication skills including conflict management and the ability to negotiate
Excellent attention to detail
Strong analytical skills and ability to prioritize
Strong ability to plan, implement, and monitor the statistical processes for clinical studies
Ability to solve moderate to complex problems
Strong ability to effectively manage multiple tasks and projects
Ability to lead and coordinate small teams
Roles and Responsibilities:
Provides input into and reviews statistical deliverables.
Coordinates the development of analysis plans, table shells, programming and table specifications, data review, statistical analysis and the production of tables, listings, and figures.
Writes and reviews statistical sections of integrated reports.
Acts as statistical team lead for single complex studies or groups of studies.
Trains and mentors new or junior statisticians on statistical methods.
Supports the preparation of Request for Proposal.
Provides input into and reviews CSR and other summary reports.
Analyzes and interprets clinical trial results using sound statistical methodology.
Prepares Statistical Analysis Report (SAR).
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in area of expertise.
Works independently; receives minimal guidance on day-to-day work and new projects or assignments.