Job Description

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.

Our Biostatistics Team is growing and we’re looking to add lead statisticians to our growing team to work across various projects and clients. We have two different roles within our team, and the ideal candidate would fit the criteria described below.

PRINCIPAL BIOSTATISTICIAN

THE FOCUS OF THIS ROLE INCLUDES:

• Holding CRO/Partners accountable for the high quality standards of their deliverables.
• Develop design options and providing high quality decision support to enable the business to make informed decisions.
• Statistical expertise in the design, analysis, and interpretation of clinical trial programs; submission and defense of regulatory filing.
• Self-motivated, hardworking, dependable, and positive team-oriented personality.

THE KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED FOR THIS ROLE INCLUDE:

• PhD in Statistics or Mathematics(containing a substantial statistical component) with experience in pharma/healthcare or other relevant area.
• In depth knowledge of the technical and regulatory requirements related to the role
• Expert leadership capabilities to be able to lead and direct project work.
• Experience in vaccines, including filing, and advisory committee experience is a plus.

PRINCIPAL BIOSTATISTICIAN ABLE TO LEAD ISS/ISE, SUBMISSION OVERSIGHT AND STRATEGY

THE FOCUS OF THIS ROLE INCLUDES:

• Provides expert knowledge within the department on statistical and regulatory issues, provides project guidance and statistical advice. Provides expert knowledge and experience of complex trials design and submissions across different therapeutic areas.
• 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.
• 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.

THE KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED FOR THIS ROLE INCLUDE:

• Must have submission, ISS, ISE experience.
• 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.

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