19 of 19 CDISC Jobs

strategic initiatives and partnerships across a matrixed organization.Oversee data ingestion, transformation, and validation processes for clinical trial data, ensuring compliance with GCP/GxP, CDISC, and SOPs.Collaborate with CROs and internal teams to optimize data flow, versioning, and retention policies.Build and optimize data pipelines for both structured and unstructured clinical … experience with oncology clinical trials, including regulatory-compliant management of clinical biomarker data and application of data standards (e.g., Clinical Data Interchange Standards Consortium [CDISC], Study Data Tabulation Model [SDTM], Analysis Data Model [ADaM]).Deep familiarity with FAIR (Findable, Accessible, Interoperable, Reusable) data principles, data harmonization, and enterprise data governance ...

document “what the data means,” not only “what the code does,” in a way that supports reuse and governance.Clinical trial standards familiarity: Exposure to CDISC SDTM, ADaM (or similar concepts) and an interest in deepening this knowledge on the job.Clinical study domain: Familiarity with clinical study conduct and data flows ...

including SAS/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 emerging ...

specifications and data transfersQualificationsBachelor's Degree in Statistics, maths, health informatics, data analytics, computer science,or life sciences fieldSAS Base Certification required;Experience with CDISC SDTM conversion would be an advantage Excellent analytical, written and oral communication skillsEntry level positions are available for recent graduates. Training in SDTM ...

procedures; exposure to Python is beneficialUnderstanding of database design, data structures, and clinical data workflowsFamiliarity with the pharmaceutical drug development processExperience working with CDISC SDTM standards and domains (e.g., EG, CO, DM, RE, VS, SUPP)Strong analytical, problem-solving, and organizational skillsHigh attention to detail with a commitment to data ...

Commensurate experience will be considered.Minimum of 2 years of Clinical Data Management experience using electronic data capture systems. Familiarity with clinical research processes and CDISC/CDASH/SDTM standardsEffective oral and written presentation and communication skills.Strong attention to detail and a commitment to high quality work, customer service ...

Commensurate experience will be considered.Minimum of 2 years of Clinical Data Management experience using electronic data capture systems. Familiarity with clinical research processes and CDISC/CDASH/SDTM standardsEffective oral and written presentation and communication skills.Strong attention to detail and a commitment to high quality work, customer service ...

Commensurate experience will be considered.Minimum of 2 years of Clinical Data Management experience using electronic data capture systems. Familiarity with clinical research processes and CDISC/CDASH/SDTM standardsEffective oral and written presentation and communication skills.Strong attention to detail and a commitment to high quality work, customer service ...

Commensurate experience will be considered.Minimum of 2 years of Clinical Data Management experience using electronic data capture systems. Familiarity with clinical research processes and CDISC/CDASH/SDTM standardsEffective oral and written presentation and communication skills.Strong attention to detail and a commitment to high quality work, customer service ...

Mathematics, Statistics, Computer Science, or a related subject, or equivalent practical experience.Programming experience in a pharmaceutical, biotechnology, CRO industry, having worked in reporting clinical trials using CDISC standardsPractical programming skills such as R, Python, etc.,Experience producing validated outputs from clinical or observational datasets.Strong attention to detail and experience performing … probability of success. We’re uniting science, technology, and talent to get ahead of disease together.Find out more: Our approach to R&DSkillsAgile Methodology, CDISC ADaM, Clinical Data Interchange Standards Consortium (CDISC) Standards, Clinical Data Standards, Clinical Development, Clinical Program Management, Clinical Programs, Data Analysis Using SAS, Data Engineering, Data ...

technical challenges.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 of modern technologies … transformation initiatives.Knowledge of 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 ...

close-out stages in line with protocol requirements, standard operating procedures (SOPs/PGs), Good Clinical Programming Practices (GXP), Clinical Data Interchange Standards (CDISC) and other applicable sponsor or regulatory requirements.Essential Functions:SAS Pre-lock programming - Deliver and support all pre-database lock SAS programming processes associated with data collection … cleaningData import and integration - Support data import programming and reconciliation activities as neededData transfer programming - Deliver and support raw/CDASH, lab only, CDISC/SDTM or sponsor specified custom data transfersProcess Improvements - Actively participate in process improvement initiativesQuality/timelines - Ensure that data programming delivers quality outputs on time ...

data structures, and ensure program-level standardization for effective pooling and efficient case record tabulation (CRT) production.Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. program-level strategies).Provide … refinement of templates, standards, and governance.Maintain up-to-date advanced knowledge of statistical programming languages (e.g. R, SAS, ) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), act as an expert for advanced analysis, reporting, automation and enterprise-scale workflow optimization, and drive adoption of reusable solutions and modern approaches ...

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 … master’s degree or 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 with ...

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 ...

procedures.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 StandardsWhen serving … 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 industry and regulatory ...

interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysisDevelop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documentsReview statistical deliverables such as tables, figures, listings and analysis datasetsConduct departmental induction course and project-specific training … understanding of the statistical principles, concepts, methods, and standards used in clinical researchExpert knowledge and understanding of the SAS programmingExpert knowledge and understanding of CDISC ADaM standardExpert knowledge and understanding of pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysisExpert knowledge ...

requests, making sure they are complete, accurate, and delivered on time.You will configure study structures, repositories, datasets, reporting components, and access in line with CDISC and governance requirements.You will manage role-based access, study configurations, and Git/Azure DevOps resources using approved requests and compliant processes.You will coordinate environment … clinical trial results generation, reporting, and submission processes.You have experience supporting Statistical Computing Environments, including process flows, user access, and Biometrics requirements.You understand CDISC standards, including SDTM and ADaM, and have worked with Tables, Figures, and Listings.You have worked in regulated pharmaceutical environments and understand SDLC, validation, audit readiness ...

Department on upcoming changes to those standards. May contribute to presentations at industry conferences and roundtables.• 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 ...