Senior Statistical Programmer - Remote
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About MMSAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time.Job Specific Skills:Mastery and trained on generating tables, listings, and graphs from clinical trial databases using SASUtilizes System Development Life Cycle (SDLC) for programming deliverablesAdvanced user in SAS programming, SAS Base, and SAS MacrosAdvanced knowledge of E-Submission Standards, Guidelines and RegulationsMastery and trained on SDTM standards including ability to write specificationsAdvanced knowledge of ADaM standards including supporting specification writingProficient with MS Office applicationsAdvanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirementsAdvanced experience with pooling of data sets for submissionsAdvanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSPLead study or small programming project teamsJob Requirements:Masters required for all Statistics rolesMinimum of 5 years’ experience in Statistical Programming or similar field requiredExpert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishmentProficiency with MS Office applications. Hands-on experience with clinical trial and pharmaceutical development preferred. Good communication skills and willingness to work with others to clearly understand needs and solve problems. Excellent problem-solving skills. Good organizational and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, FDA, and GCP requirementsBasic understanding of CROs and scientific & clinical data/terminology, & the drug development process.