MMS Holdings Inc. Manager, Biostatistics in Kalamazoo, Michigan
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn (https://www.linkedin.com/company/mms-holdings-inc-/) .
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.