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Senior Statistical Programmer- REMOTE

Company: Sdc (statistics & Data Corporation)
Location: Denver
Posted on: November 22, 2021

Job Description:

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.Primary ResponsibilitiesPerform all statistical programming required for clinical trial analysis and reportingApply appropriate statistical methods for data analysis and provide statistical programming expertise for project teamsReview the Statistical Analysis Plan in preparation for programming the planned analysesDesign/develop SAS macros and other utilities to expedite SAS programming activitiesGenerate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client requestParticipate in statistical program validation and quality control activitiesDevelop SDTM aCRF and specifications; complete programming and validation of CDISC SDTM and ADaM datasetsReview ADaM specification documents and ensure the specifications meet the analysis criteria specified in the SAPReview pinnacle 21 reports and ensure compliance with CDISC and FDA guidelinesDevelop define.xml, study data reviewer's guide and analysis datasets reviewer's guideActively participate in study team meetingsInteract with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projectsParticipate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data ManagementProgram data cleaning checks, as necessary, to assist Data Management's data cleaning activitiesParticipate in installation/validation of statistical software packages throughout the software development lifecycleDevelop and maintain the infrastructure for project files of SAS datasets and SAS codeMentor junior level statistical programmersEnsure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirementsAdhere to all aspects of the SDC's quality systemComply with SDC's data integrity & business ethics requirementsPerform other related duties incidental to the work described hereinAdherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirementsThe above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.RequirementsStrong analytical skills, with the ability to process scientific and medical dataVery strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS MacrosBasic understanding of SAS/GraphStrong problem-solving skillsAble to work independentlyExcellent knowledge of statistical programmingProficient in manipulating and analyzing SAS dataAbility to identify data issues, present problems, and implement solutionsThe capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleaguesGood organizational and time management skills, with the ability to multi-taskFamiliarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)Understanding of CDISC SDTM and ADaM data modelsStrong interpersonal communication and presentation skillsEducation Or Equivalent ExperienceBachelor's degree in computer science, statistics or other related, scientific field and four years of relevant professional experience; or an equivalent combination of relevant education and/or Jobble

Keywords: Sdc (statistics & Data Corporation), Denver , Senior Statistical Programmer- REMOTE, IT / Software / Systems , Denver, Colorado

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