Manager, Biostatistics (Remote)

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Our Biostatistics Team is growing and we’re looking to add a motivated leader to our team! A successful candidate would meet the requirements below.

The focus of this role includes:

• Work with Associate Director and Director of Biostatistics to manage clinical trial programs/projects or submissions from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects.
• Coach, mentor, develop, provide technical review, advice and expertise to Biostatisticians assigned to the programs/projects
• Lead statistical and programming teams and interact with clients and/or internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
• Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling and testing, analysis and reporting.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.

The knowledge, skills and experience required for this role include:

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 5 year’s relevant experience or a Master’s degree in these fields with at least 8 year’s relevant experience, with demonstrated exceptional ability and performance.
• Significant contribution, outstanding and sustained performance may be used in lieu of the requirement on the number of years of relevant experience.
• Submission, ISS, ISE experience is a definite plus.

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