Job Description

MMS is an innovative data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a proven scientific approach to complex trial data and regulatory submission challenges. With a global presence across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions rooted in strong science and decades of regulatory experience, assisting clients in developing and marketing life-changing therapies to positively impact lives worldwide. MMS recognizes that talented staff drive our success. We prioritize identifying and attracting top talent, along with ongoing training to enhance core skills. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a diverse and global talent pool strengthens the company. Follow MMS on LinkedIn for updates. Responsibilities: Create randomization and kit schedules independently and collaborate with sponsor teams. Develop phase 1-4 SAPs and contribute to iSAPs; create SAP TLF shells for all phases and studies. Review ADAM and TLFs; work with clients and programmers to resolve comments. Apply strong programming and logic skills (working knowledge of SAS). Utilize drug development knowledge for high-quality statistical analyses. Perform sample size calculations for various study scenarios and designs. Lead projects and smaller submissions; manage client meetings and collaborate with regulatory PMs and sponsors. Maintain strong knowledge of CDISC standards (SDTM and ADaM) and FDA guidance across therapeutic areas. Understand various tools used in our processes. Possess high-level knowledge of drug development as it relates to biostatistics. Support Data Safety Monitoring Boards by preparing and presenting output as unblinded statistician. Review statistical sections of protocols; ensure appropriate methods and provide feedback. Create statistical sections with minimal support. Proficient in MS Office applications. Understand project management tasks such as timelines, scope, and resource estimation. Provide ICH guideline-based input relevant to statistics. Assist in preparing and reviewing statistical methods and results sections for CSR in collaboration with medical writers. Requirements: Experience in immunogenicity and serotype vaccine studies preferred. Pediatric study experience preferred. Degree in Biostatistics, Statistics, Mathematics, or related field; Master's or PhD preferred, or extensive relevant experience. Minimum of 7 years in biostatistics or a similar field. Expert knowledge of scientific principles and concepts. High-level understanding of drug development related to biostatistics; ability to produce high-quality analyses. Thorough knowledge of clinical data preferred. Strong experience with data management and TLG production. Excellent scientific writing skills. Resourceful in biostatistics; willing to mentor others. Proficient with MS Office applications. Hands-on experience with clinical trials and pharmaceutical development preferred. Good communication skills and team-oriented problem-solving approach. Excellent organizational skills. Familiarity with 21 CFR Part 11, FDA, and GCP requirements. Basic understanding of CRO operations, scientific/clinical data, terminology, and the drug development process. Required Experience: Senior IC Key Skills: Graduate degree in Engineering, Accounts, Building Materials, Customer Support, or Horticulture. #J-18808-Ljbffr MMS

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