Summarized Purpose :
Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department.
Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies.
Acts as a project manager, overseeing the statistical and programming aspects of clinical trials from design, through analysis and reporting, acting as the lead statistician on multiple projects.
Represents the department within the company and with interactions with client companies and regulatory agencies, on simple to complex study design matters, directly contributing to complex study proposals and bids, representing the department at bid defenses.
Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.
Essential Functions :
Provides expert knowledge and experience of complex trials design across different therapeutic areas.
Contributes to process improvement and departmental initiatives.
Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Provides management with timely, accurate status and resourcing reports.
Allocates and coordinates resources within the team to achieve timelines, time management of own and team's time spent on projects.
Review protocols for completeness,appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.
Ensures that appropriate validation for statistical analyses and statistical appendices is implemented.
Contributes statistical methods section for integrated clinical statistical reports.
Education and Experience :
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years’).Master's degree in statistics, biostatistics, mathematics or related field
Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage.
In somecasesan equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities :
Working Environment :
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)