21 of 21 CDISC Jobs

programming Core Skills & Knowledge Strong, proven proficiency in SAS for producing derived analysis datasets and TFLs In‐depth understanding of clinical data structures, including CDISC standards (SDTM, ADaM) and relational databases Hands‐on experience with upstream data handling – multiple data forms, eDC, workflow, and SDTM Ability to deliver downstream outputs ...

/MACRO, SQL and SAS/BASE procedures, SAS/GRAPH and Statistical procedures. Demonstrable knowledge of regulatory requirements (FDA, ICH), such as CDISC, SDTM/ADaM IG etc. Defines and drives the global technical strategy for programming automation, standardization and advanced analytics capabilities within Global Biometry. Identifies and implements ...

communication, interpersonal, and presentation skills Willingness to travel up to 10%, potentially including international travel Nice to Have Familiarity with data management standards (GCDMP, CDISC, SDTMIG, CDASH, ADaM) Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, or similar clinical technologies Experience integrating or programming with REST ...

clinical-trial design Experience developing SAPs and contributing to study design and protocols Experience leading statistical activities across clinical trials Strong knowledge of SAS, CDISC standards and regulatory requirements Confident communication skills and the ability to work directly with clients What’s on Offer Remote working within the UK Competitive ...

progression. Key responsibilities: Lead statistical activities across global clinical trials Contribute to study design, protocols, SAPs, analyses and reporting Support regulatory submissions and ensure CDISC compliance Mentor junior Biostatisticians and Statistical Programmers Collaborate with clinical, programming and data management teams Act as a trusted statistical contact for clients and project ...

Uxbridge. You will be embedded with cross-functional teams to turning complex clinical data into submission-ready outputs for regulators, using SAS and CDISC standards to shape regulatory submissions and patient outcomes. With 7+ years in pharma statistical programming, you will influence strategy, mentor others, and lead electronic #J ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Cytel Inc. is seeking a Senior Statistical Programmer to support or lead SAS programming for one or more Phase I-IV clinical trials, leveraging SDTM and ADaM standards. This fully remote role allows you to ...

Outside IR35 engagement and the opportunity to work directly for a sponsor while enjoying CRO resources. The role focuses on delivering SAS programming for CDISC SDTM/ADaM, creating tables, listings, and figures, and collaborating with Biostatistics, Data Management, and Clinical teams to meet regulatory timelines. #J-18808-Ljbffr ...

part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values ...

regulators trust. You'll design and implement technical solutions that directly influence whether a medicine moves forward, or doesn't. That means working with CDISC standards, ADaM specifications, SAS programming, and electronic submissions, things you already know inside and out. But it also means something bigger: your technical decisions will … years of statistical programming experience in the pharmaceutical or biopharma industry, including hands-on involvement in major regulatory submissions Are deeply fluent in SAS, CDISC/SDTM/ADaM standards, and the end-to-end clinical data pipeline Understand the full drug development lifecycle, from eDC data collection through ...

components under leadership, tackling complex clinical programming tasks, and coordinating with study teams to ensure quality and regulatory compliance. The ideal candidate has extensive CDISC experience in oncology, strong communication, and ability to manage multiple activities in a client-facing CRO environment. #J-18808-Ljbffr ...

between speed-to-market and regulatory compliance (GxP, 21 CFR Part 11, GDPR, HIPAA). Cultivate strategic partnerships with data providers and standards bodies (CDISC, HL7 FHIR) to accelerate Evinova's product capabilities. Champion a culture of experimentation, intellectual honesty, and continuous learning within your product area and across … founder of a technology company, or as the first product hire at an early-stage start-up. Working knowledge of clinical trial data standards (CDISC SDTM/ADaM, CDASH) and regulatory submission workflows. When we put unexpected teams in the same room, we unleash bold thinking with the power ...

Identify and implement improvements, including use of AI/ML.Contribute to departmental initiatives and technical strategy. Quality & Compliance Ensure adherence to standards (e.g., GPP, CDISC) and regulatory requirements. Perform QC on critical outputs and technical documents (e.g., cSDRG, ADRG).Maintain governance and oversee TMF compliance. Strategy & Innovation Drive adoption … Agile delivery methodologies and collaborative product development approaches. Demonstrated experience leading programming activities for complex clinical studies or multiple projects. Strong understanding of CDISC standards, regulatory expectations, and quality/compliance requirements. Excellent analytical, problem-solving, communication, and stakeholder management skills. Experience mentoring or guiding junior team membersAt ViiV Healthcare ...

Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When … serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other ...

trials, collaborating with sponsors and cross‐functional teams to deliver high‐quality analyses in line with regulatory expectations. Strong SAS programming and CDISC SDTM/ADaM expertise are essential, as is the ability to manage projects and communicate clearly with clients and stakeholders. #J-18808-Ljbffr ...

consultancy across the stats function. You will lead design reviews, analysis plans, and reports for multiple sponsor projects. You will develop SAS programs, ensure CDISC/SDTM/ADaM compliance, maintain documentation, and contribute to manuscripts and bids. The role requires a Master's in math/stats ...