Associate Director
Core
Design clinical trials, develop analysis plans, interpret results, and prepare regulatory submissions for oncology, hematology, cell therapy, immunology, and cardiovascular disease assets.
Role type
Senior IC biostatistician (associate director level)
Builds
Clinical study reports, regulatory submissions, and publications
Domain
Pharmaceutical industry, clinical trials, biostatistics
Required skills
SAS, R, Python, advanced statistical analysis, data manipulation, graphing, simulation, clinical trial methodology, regulatory landscape knowledge, project management
Preferred skills
People management, mentoring, strategic partnership in drug development
Technologies
SAS, R, Python
Responsibilities
Collaborate in design of innovative and efficient clinical trials, including selection of study population/endpoints; Defend protocols and analysis plans at internal governance reviews; Independently author and/or review protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents; Present summary data and analyses results; Provide statistical support and leadership to address health authority requests; Manage multiple studies to ensure consistency and adherence to standards; Develop and advise team members; Engage as a matrix team member on project teams; Effectively communicate the DQS Mission and Vision; Enable a culture of inclusiveness, compliance with process, and constructive questioning; Provide leadership to empower and develop the team; Provide guidance to employee's development plans and carry out performance review and feedback.