Perform management functions relating to the administrative and scientific activities of specific project work and team members. Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Function as Biostatistics Project Leader for multiple protocols, projects, or NDA projects, including coordinating with other PPD divisions and interacting with the client and regulatory agencies.
- Become familiar with the activities outlined in the department’s Working Practice Documents and contribute changes as needed. Learn and follow departmental procedures for statistical analyses and programming work
- Serve as a lead statistician on large and complex projects
- Lead a project team. This involves conducting team meetings, maintaining project timelines, assessing resource needs, providing resources, and budget preparation. Ensure that SOPs are being followed and that appropriate project documentation is ongoing.
- Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Also contribute to writing appropriate protocol sections.
- Provide randomization schemes and appropriate documentation.
- Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming. Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation.
- Write / review analysis plans and guide others on the team in its implementation. Define appropriate methods and procedures for statistical analysis.
- Develop or supervise creation of table and listing specifications. Ensure that proper validation for statistical tables and listings is being implemented.
- Perform statistical analysis for key efficacy endpoints.
- Prepare reports, manuscripts, and other documents. Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
- Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
- Understand project budget as it relates to project workscope and communicate proactively with
MS/MA degree in statistics, biostatistics, mathematics or related field and a minimum of four years’ experience required
-Minimum of 2 years’ experience with Ph.D;. or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities.
Knowledge, Skills and Abilities:
• Strong SAS programming skills.
• Ability to direct and promote teamwork in a multi-disciplinary team setting.
• Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments.
• Evidence of strong management skills, as shown through management of multiple projects and/or staff members.
• Demonstrated initiative and motivation.
• Excellent written and verbal communications skills.
• Good organizational skills with the ability to adapt and adjust to changing priorities.
• Positive attitude and the ability to work well with others.