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Associate Manager, Biostatistics - Fichardt Park

MMS

MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, 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: Can create randomization and kit schedules independently, collaborate with sponsor, randomization, and drug supply management teams. Can create a randomization plan with no supervision. Can develop SAPs and iSAPs text and shells with no supervision. Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments. High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques. Has the ability to apply drug development knowledge during production of high-quality statistical analyses. Can perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations. Leads complex projects, programs, and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor. Is familiar with and stays current with the latest industry practices and updated regulatory guidelines. Understands the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of Power BI for dashboard development or use of external SharePoint). Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician. Has high level knowledge of drug development as it pertains to biostatistics. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Produces and presents external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction. The knowledge, skills and experience required for this role include: Minimum of 5 years’ experience in Biostats or similar field required. Ability to anticipate and effectively resolve potential problems with client demands. Demonstrates managerial skill and experience. If you have not received a response within 14 days of your application, please consider your application unsuccessful. Powered by JazzHR Apply Now

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