Senior Biostatistician - Early Phase | O-751

.PPD clinical research services' mission is to improve health.It starts as an idea to cure.It becomes a life saved.All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people.We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.We are passionate about being data and technically agile and driving enhanced value for our clients and patients.Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.As a Senior Biostatistician within our Early Phase team, you will function independently as a project lead or lead statistician to deliver the project tasks/responsibilities.As well you will perform project management functions relating to the administrative and scientific activities of specific project work and team members.Essential Functions:Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes changes as needed.Follows departmental procedures for statistical analyses and programming work.Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across large and complex projects.Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis.Contributes to writing appropriate protocol sections.Provides randomization schemes and appropriate documentation.Writes/reviews analysis plans and guide others on the team in its implementation.Defines appropriate methods and procedures for statistical analysis.Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming.Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation.Performs statistical analysis for key efficacy endpoints.Prepares reports, manuscripts, and other documents.Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning