Key Responsibilities
This role involves driving customer interactions, understanding their needs for clinical trial design, data analysis, and regulatory agency interactions. You will develop innovative clinical trial designs that meet regulatory standards and patient needs, incorporating multiple outcomes within the primary endpoint.
You will effectively communicate complex challenges and solutions to non-statistical audiences, such as Chief Medical Officers or regulatory agencies. Additionally, you will lead sophisticated statistical analyses and simulations to address complex clinical challenges across various therapy areas.
Your responsibilities will also include collaborating in the research, development, evaluation, and implementation of innovative statistical methodologies for clinical development, focusing on multivariate methods and Generalized Pairwise Comparisons (GPC). You must stay up-to-date with the latest developments in statistical methods and their applications in the clinical research industry.
Requirements
* A Ph.D. in (bio)statistics or a comparable scientific domain, or equivalent statistical experience.
* At least 5 years of professional experience in biostatistics within the biopharma R&D industry, demonstrating a proven track record in clinical trial designs and statistical methodology.
* Previous experience in interactions with FDA/EMA for trial design submissions.
* Robust experience with advanced statistical methodologies and simulation techniques in pharmaceutical development.
* Demonstrated ability to build relationships, understand customer needs, and provide effective solutions.
* Good communication and presentation skills, with the ability to articulate complex technical concepts to both statistical and non-statistical audiences.
* Ability to handle multiple projects in parallel, clearly managing timelines & expectations internally and externally.
* Proficiency in R and/or Python programming.