Title matches your search • Salary estimate available • Direct apply link
Get weekly matches like thisMMS is a award-winning, data-focused clinical research organization (CRO). Visit www.mmsholdings.com or follow MMS on .Senior Statistical ProgrammerJob Specific Skills:Mastery and trained on generating tables, listings,…
Read full description
MMS is a award-winning, data-focused clinical research organization (CRO). Visit www.mmsholdings.com or follow MMS on .Senior Statistical ProgrammerJob 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.Should you not have received a response within 14 days of your application, please consider your application unsuccessful.