Senior Statistical Programmer

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, 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 inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com
or follow MMS on LinkedIn .Senior StatisticalProgrammerConfidently displays excellent internal and external customer serviceResponsible for implementation and execution of high quality clinical programmingDemonstrates strong understanding of ICH guidelines, as applicable to clinical programmingCreates and presents programming training exercises, trains new programmers, and serves as mentorUtilizes System Development Life Cycle (SDLC) for programming deliverablesTrains via self-study and self-practice independently and explores advanced topics related to programming and/or drug developmentInteracts directly and independently with client to coordinate all facets of the project; highly competent communicator with excellent client interaction skillsProvides high level of support to the statisticians and medical writers on all programming matters according to client requirementsWorks with statisticians to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphsGenerates tables, listings, and graphs from clinical trial databases using SASDevelops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related softwareDevelops data and programming specifications jointly with other programmers and biostatisticiansDesigns specific data presentations including creative summary tables, graphs, and patient listingsAssists with preparing data validation plan based on customer needsReviews data management guidelines for computer edit/validation checksIndependently implements and validates QC findings in compliance with the NC Handling ProcedureConducts thorough self-reviews of deliverables prior to release to client; serves as high level reviewer for othersFollows processes related to project management as appropriate for programmingprojects (e.g. updating VeoProject, updating PSS, close-out procedures etc)Demonstrates extensive knowledge of departmental processes (e.g.competency in programming software and willingness to share information)Takes initiative to suggest and implement programming process improvements and follows through to completionLeads most projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the clientDemonstrates excellent internal and external leadership skills for projectsFully accountable for providing highest quality deliverables of entire project to satisfy or exceed client requirementsMay produce and present external company presentations providing industry visibility for the organizationAccountable for timelines, as well as, internal team interactionsComplies with Document Control ProcedureComplies with Record Control ProcedureEnsures compliance to applicable ISMS policies and proceduresJob Requirements (Minimum Education / Experience / Training / Skills)Preferably a minimum of 6 years experience in the Clinical Research/Statistical Programming EnvironmentCollege graduate in computer science or related field, or related experienceHas high level knowledge of drug development as it pertains to programming; has the ability to apply drug development knowledge during production of high quality programsExtensive hands-on experience with clinical trials and pharmaceutical developmentStrong experience with data and production of TLGsStrong programming and logic skillsThorough understanding of CDISC standards and HL-7 standardsExtensive experience in pharmaceutical or CRO industry preferredThorough knowledge of clinical database structuresAbility to program data presentations, using program such as SAS proceduresSubject matter expert for SAS programming skills; willing to guide others in a variety of programming techniquesStrong proficiency with MS Office applicationsExcellent organizational and communication skillsStrong familiarity with ISO 9001:2000 requirementsPlease consider your application unsuccessful if we do not reach out to you within 14days of your submission.
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