Senior Biostatistician - Remote (US)

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.Senior Biostatistician:Responsibilities: Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teamsDevelop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studiesReview ADAM and TLFs; work with client and programmers to resolve commentsStrong programming and logic skills (working knowledge of SAS)Ability to apply drug development knowledge during production of high quality statistical analysesPerform sample size calculations for a variety of scenarios and study designsLeads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsorStrong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas. Understand the various tools that we work withHigh level knowledge of drug development as it pertains to biostatisticsProvides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statisticianReview the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal supportHigh proficiency with MS Office applicationsDemonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimationProvide ICH guideline based input as applicable to statisticsPrepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writersRequirements:College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience requiredMinimum of 5 years’ experience in Biostatistics or similar field requiredExpert knowledge of scientific principles and concepts. Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analysesStrong SAS programming, SAS base, SAS macro experienceThorough knowledge and understanding of clinical data preferredStrong experience with data and production of TLGsExcellent scientific writing skillsStrong resource for biostatistics; willing to guide others in a variety of biostatistical techniquesProficiency with MS Office applicationsHands-on experience with clinical trial and pharmaceutical development preferredGood communication skills and willingness to work with others to clearly understand needs and solve problemsExcellent problem-solving skillsGood organizational and communication skillsFamiliarity with 21 CFR Part 11, FDA, and GCP requirementsBasic understanding of CROs and scientific & clinical data/terminology, & the drug development processPlease consider your application unsuccessful if we do not reach out to you within 14 days of your submission.