1 to 25 of 29 CDISC Jobs

/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 ...

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 ...

synonym lists in Medidata Coder. Develop customized reports and data outputs to support clinical development needs. Serve as a subject matter expert for CDISC standards and related data structures. Ensure deliverables and processes comply with SOPs, GxP, and applicable regulatory requirements. Provide technical guidance, support, and training to Clinical system ...

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 ...

DDOS, SIEM) - Experience in the healthcare and life sciences industry, including familiarity with compliance and security frameworks (HIPAA, GxP) and clinical data standards (OMOP, CDISC, FHIR) Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. ...

Life Science 6+ years of industry programming experience, including meaningful involvement in regulatory submissions Deep expertise in SAS programming and a strong command of CDISC standards (SDTM, ADaM) Solid understanding of the end‐to‐end drug development process — from trial design through to submission The ability to communicate with clarity ...

data management, including risk-based data collection and cleaning strategies, eCRF design, external data management, and coding, with strong knowledge of CDISC, CDASH, and SDTM standards. You have a proven track record of managing CRO/vendor relationships, including operational performance oversight and budget monitoring, and are experienced ...

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 ...

Biostatistics and Clinical Data Management. Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs. Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guides and submission standards. An autonomous, collaborative work style, a curious mind and a keen ...

work effectively with virtual teams within different cultural environments. eCOA, ePRO experience is a plus. Knowledge/experience of data standards such as CDISC SDTM is a plus. Strong project management skills. Educated to degree level in life sciences and/or computer sciences. Fluent English. Proven ability to manage ...

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 ...

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 ...

biotech company to recruit an experienced Senior or Principal Statistician to support clinical development programmes. The role focuses on SAPs, SAS & R programming, and CDISC SDTM/ADaM standards, with involvement in regulatory submissions (NDA/MAA) and cross-functional collaboration across Clinical, Medical & Regulatory teams. The position offers remote ...

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 ...

Worldwide Clinical Trials is seeking a skilled Statistical Programmer to join our Global Programming team. You will develop and validate CDISC SDTM/ADaM datasets, create TFLs and listings, and contribute to submission-ready packages across multiple studies. You will review study specs, lead programming efforts on medium complexity trials ...

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 ...

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 ...

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 ...

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 valuesWe believe … above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM/ADaM standards. Strong QC/validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience ...

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 ...

execution;HOW - Knowledge & ExperienceKnowledge & Experience (essential):Proficiency in statistical programming package(s), SAS is required;Familiar with Global Clinical Data Interchange Standards Consortium (CDISC);Experience in SDTM and ADaM specification and programming;Experience in reporting and TFL programming.8+ years' programming experience in pharmaceutical/biotech/CRO environment in drug ...

type research‐ready and interoperable. Make clinical trial standards possible through import (from REDCap and other commercial EDC/CTMS solutions) and export (to CDISC SDTM) into capabilities investigators, sponsors, and study sites can effectively use. Implement validation and certification of D4L Collect including … Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially CDISC (SDTM, CDASH) at a conceptual level, and a working understanding of HIPAA + GDPR as they apply to clinical trials and real‐world data. Bachelor’s degree ...