Description:
Manager I, Biostatistics

Job Purpose:

Designs, plans and executes biostatistical and components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of medical devices. Uses sound statistical and scientific methodologies to conduct studies relating to the life processes of animals and humans. In development-phase projects, prepares the components of protocols related to statistical design and analysis which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies appropriate statistical theories, methods, and software. Organizes and interprets data into tabular forms amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinical programmers. May partner in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Key Responsibilities:

Take an active role in assisting the clinical department to define their strategy for clinical studies.
Oversee biostatistical issues related to appropriate study design and hypothesis development.
Oversee the quality of the statistical design and analysis and ensure that worldwide processes are implemented in compliance with applicable regulations.
Provide guidance or interface directly with regulatory authorities (e.g. FDA) on statistical and data issues pertaining to study design, data collection, hypothesis testing, and study results.
Recruit, train, develop and mentor team members.
Monitor regulatory initiatives (US and international) and innovative practices that impact biostatistics and implement appropriate changes to the groups’ practices to ensure regulatory compliance.
Interface with CRO management to ensure quality of their biostatistics activities.

Experience:
Qualifications:

· Education: Master’s Degree required, PhD preferred in Biostats/Stats

· Professional Experience: 7 + years with MS, 4 + years with PhD

· Clinical Trial experience required

· Management experience preferred