Biostatistics Manager, Medical Affairs

Manager, Biostatistics, Medical Affairs

Responsibilities
The Manager, Biostatistics (Medical Affairs) will be functioning as a project level statistician. The role is responsible for developing, coordinating, performing, and validating all statistical analyses in support of Medical Affairs, inclusive of overseeing the work of statistics and programming for external vendors as needed.


Essential Functions

• Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of products.
• Participate in Publication Planning Meetings as a Biostatistics representative contribute to publication planning including timelines, statistical and analytical requirements for publications, projects, and publications plans.
• Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
• Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
• Review publications, marketing materials, and education and training materials that contain clinical data and product claims
• Stay informed with data being generated in current clinical development programs
• Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
• Provide guidelines and standards to CROs to ensure quality of deliverables
• Provide support for approval for payers at the country level.

Job Requirements:

• MS, MPH, or PhD in statistics, mathematics, or related field, with 4+ years (MS/MPH) or 2+ years (PhD) experience
• Experience supporting Medical Affairs/publication of analysis results (e.g. abstracts, posters, manuscripts) a plus
• Proficient in US drug development regulations pertinent to statistical analysis
• Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards
• Excellent writing and communication skills
• Travel 10-20%.