The Senior Statistical Programmer will be responsible for review datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. This individual will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. ResponsibilitiesCollaborate with the study teams to design data structure and specifications for ad hoc and study deliverables including ADaM datasets, tables, figures, listings and analysis submission content.Collaborate with study teams to ensure the quality and accuracy—thus submission readiness—of clinical data as required by authorities (SDTM, ADaM, tables, figures, listings, define.xml).Lead and oversee requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.Lead and oversee the in‑house specification and delivery of ISS and ISE datasets and associated output when not provided by CRO.Lead and oversee the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.Lead and oversee the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.Work closely with clinical study teams to plan and execute activities to ensure project timelines are met with high quality deliverables.Collaborate with CR&D staff regarding data analysis requests.Perform additional statistical analyses including: support responses to regulatory agencies; generate integrated summaries of safety and efficacy; support publications and presentations; support planning and reporting of clinical trials via exploratory analyses of available data. QualificationsBSc in Computer Science, Mathematics, Statistics or a related area with relevant experience.At least 5+ years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS software.In‑depth understanding of clinical programming and/or statistical programming processes and standards.In‑depth understanding of regulatory requirements relevant to statistical programming (e.g., GCP, ICH).Extensive experience with statistical programming using SAS, including development and use of SAS macros; strong programming and problem‑solving skills.Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM).Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities.Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.Experience working in cross‑functional, multicultural and international clinical trial teams. BenefitsHome‑based remote work opportunitiesGreat work/life balanceCollaborate on projects and innovations with industry leaders in the Pharma and CRO sectorsCohesive team environment fostering a collaborative approach to study workVariety of therapeutic areas, indications and study phasesJob stability; long‑term engagements and development opportunitiesCareer advancement opportunities EEO Minorities/Females/Protected Veterans/Disabled #J-18808-Ljbffr