1 to 25 of 155 CDISC Jobs

Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯

Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯

Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯

Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯

Senior Backend Software Engineer (C# .NET Core) - Revolutionise Healthcare with REST API Design! Are you ready to make a monumental impact in the healthcare industry? We're looking for a Senior/Lead Backend Software Engineer with a strong focus More ❯

knowledge with unstructured database technologies (e.g. NoSQL) and other database types (e.g. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Experience working in an Agile development environment. More ❯

Graph). Familiarity with Containerization such as Docker and EKS/Kubernetes. Familiarity with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Exposure to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯

on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)), Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines The ability to read, analyse, and communicate large and small amounts of data efficiently, including teaching/explaining data-driven results to others. Education/Qualifications More ❯

on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)), Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines The ability to read, analyse, and communicate large and small amounts of data efficiently, including teaching/explaining data-driven results to others. Education/Qualifications More ❯

and graphs. Deliver high-quality programming outputs, maintaining and validating SAS (and potentially R) programs. Program outputs for HTA dossiers, publications, and exploratory purposes. Understand and process data structures (CDISC or non-CDISC). Follow regulatory guidelines, including good clinical practice and electronic submissions. Contribute to standards creation, maintenance, documentation, and validation. Review and author data transfer specifications for external … data science, mathematics, or statistics. 7+ years of experience as a Statistical Programmer in a clinical development environment. Expertise in SAS programming and clinical statistical procedures. Extensive experience with CDISC standards and regulatory requirements. Experience supporting regulatory submissions and HTA dossiers is a plus. Ability to work independently with excellent communication and leadership skills. Preferred Skills Proficiency in R, Python More ❯

in which you will be expected to produce both datasets and outputs. Key responsibilities will include: · Writing SAS programs to create analysis datasets, tables, listings, and figures. · Adhere to CDISC standards for data management and analysis, including SDTM (Study Data Tabulation Model) and ADaM (ADAM Data Model). · Deliver all required outputs to agreed timelines and quality, (e.g., analysis datasets … outsourced to CROs, ensuring that their performance meets the agreed quality. Required Knowledge · 3+ years of experience in clinical trial SAS programming. · Demonstrated knowledge of and experience in applying CDISC standards. · Self-starter with the ability to work within a Biostatistics team. Skills and Abilities · Proficiency with SAS programming and SAS macro code development required along with a good understanding More ❯

in Health Technology Assessment/HEOR is preferable Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Experience More ❯

/or clinical drug development process Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and supportive team environment Access to cutting-edge and More ❯

checks and data exploration (e.g. using frequencies, histograms) • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice • Complete and review CDISC Validation tool reports • Ensure the appropriate standards are being applied and adhered to • Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival) • Review of project management related More ❯

Leads on process improvement initiatives within Statistical Programming and plays a key role in reviewing and update SOPs. Maintains knowledge of relevant regulatory guidance and requirements, i.e. GCP, MHRA, CDISC etc. Provides in-house training, technical support and mentoring for colleagues. Provides support to Business Development and attends bid defence meetings acting as the Statistical Programming expert. Performs ad hoc … Team Experience of Statistical Programming across Phase 1/II/III Clinical Trials Awareness of Global regulatory environment. Experience of a wide breadth of therapeutic areas. Knowledge of CDISC standards Experience in define-XML production and FDA documentation requirement About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to More ❯

Leads on process improvement initiatives within Statistical Programming and plays a key role in reviewing and update SOPs. Maintains knowledge of relevant regulatory guidance and requirements, i.e. GCP, MHRA, CDISC etc. Provides in-house training, technical support and mentoring for colleagues. Provides support to Business Development and attends bid defence meetings acting as the Statistical Programming expert. Performs ad hoc … Team Experience of Statistical Programming across Phase 1/II/III Clinical Trials Awareness of Global regulatory environment. Experience of a wide breadth of therapeutic areas. Knowledge of CDISC standards Experience in define-XML production and FDA documentation requirement About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to More ❯

listings) when not provided by CRO. Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format. Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group. Works closely with clinical study teams to plans … e.g. GCP, ICH). • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills. • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM). • Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent). • Proven ability to work More ❯

work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including … industry Good awareness of clinical trial issues, design, and implementation Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISC standards APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for More ❯

of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs Solid knowledge of CDISC standards Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail Business fluency in English – both spoken and written – is a must More ❯

in parallel - including Phase II and/or Phase III studies. Experience leading oncology studies and knowledge of RECIST is strongly preferred. Experience with creating and validating analysis datasets (CDISC ADaM standard), and Tables, Listings, and Figures. Pinnacle 21 experience is strongly preferred. Expert knowledge of SAS. Professional leadership skills coupled with exceptional communication skills. Education: Bachelor’s degree required More ❯

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Experience in R Experience with industry data standards such as CDISC(ODM: CDASH, SDTM, ADaM), HL7 FHIR, OMOP(CDM) etc. Experience with digital clinical trials protocol and Unified Study Definition Model (USDM)Experience in data modelling Closing Date for Applications - July More ❯

Base SAS, SAS/Macro, SAS/SQL; experience with SAS/Graph is a plus Demonstrated ability to develop, maintain, and troubleshoot SAS macro libraries Strong Knowledge of CDISC Standards Hands-on experience with the implementation of SDTM and ADaM datasets Experience in Define-XML creation and CDISC validation tools such as Pinnacle 21 Regulatory Reporting Experience Direct involvement … more years of experience in clinical trial programming within the pharmaceutical, biotech, or CRO industry Advanced knowledge and experience in: SAS programming: experience in R is a major asset CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices Technical and regulatory requirements related to the role Database set-up Clinical drug development Proficiency in English - conversational French would be More ❯

will be doing: You’ll lead statistical programming projects, ensuring high-quality, on-time deliverables. This includes developing and validating SDTM and ADaM datasets, performing QC reviews, and ensuring CDISC compliance. You’ll resolve Pinnacle 21 validation issues, review TLFs for consistency, and contribute to regulatory submissions. You'll also create define.xml files, develop and maintain macros, and perform data … + Masters or PH.D in Statistics. 8 years’ experience in clinical trial statistical programming. Excellent knowledge of SAS essential with R advantageous. Good working knowledge of data structures e.g. CDISC, SDTM, ADaM, Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines. What in it for you: The opportunity to be involved in a growing organisation. Enjoy a healthy work More ❯

will be doing: You’ll lead statistical programming projects, ensuring high-quality, on-time deliverables. This includes developing and validating SDTM and ADaM datasets, performing QC reviews, and ensuring CDISC compliance. You’ll resolve Pinnacle 21 validation issues, review TLFs for consistency, and contribute to regulatory submissions. You'll also create define.xml files, develop and maintain macros, and perform data … + Masters or PH.D in Statistics. 8 years’ experience in clinical trial statistical programming. Excellent knowledge of SAS essential with R advantageous. Good working knowledge of data structures e.g. CDISC, SDTM, ADaM, Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines. What in it for you: The opportunity to be involved in a growing organisation. Enjoy a healthy work More ❯

level team. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient 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. CSPD and other project-level strategies). Provide and … programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. Establish successful working relationships on individual studies with external associates according to agreed contract and internal business guidance. Act as … deliverables, proven experience in development of advanced MACROs. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications. Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). More ❯