13 CDISC Jobs

and project level.Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, etc.).Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.Implement in-house data standards.Develop software validation procedures and test plans, as necessary.Create and document more »

practices, procedures, and methodologies Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation Excellent SAS programming skills and willingness to lead the implementation of new software (i.e., R, Python) Must be highly motivated and able to work more »

related field. Proven experience as a statistical programmer in pharmaceutical or biotechnology industry. Proficiency in SAS, R, Python, or SQL programming languages. Familiarity with CDISC standards (SDTM and ADaM) and regulatory guidelines (ICH, FDA). Strong problem-solving skills and ability to deliver high-quality programming within deadlines. Excellent communication more »

and experience. • Knowledge of database set-up and report publishing requirements. • Advanced knowledge of technical and regulatory requirements related to the role. • Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices. • Advanced knowledge and experience of clinical drug development or healthcare. more »

with multiple functional areas across the company. Skills & Requirements: Advanced degree (MSc or PhD). Proficiency in statistical programming, particularly SAS. Detailed knowledge of CDISC standards (SDTM, ADAM). Excellent communication skills, both written and verbal, with the ability to communicate complex statistical concepts to non-statistical audiences. Ability to more »

with-us Position Purpose The student intern of statistical programming will take 4-6 months to generate a full suite of ADaM datasets conforming CDISC from SDTM datasets using admiral and admiralonco R packages. The code must follow the best of practice and is reusable across different therapeutic areas. They more »

with Phase I studies, exposure response analysis, cross over design, and supported pooling of PK parameters required Strong SAS technical skills and in-depth CDISC knowledge R programming experience would be a significant advantage Our client, a global mid-size Pharma, are looking to expand the early phase programming group more »

to degree level within a computing, science or mathematical subject 2+ years' SAS programing experience, within the pharmaceutical industry, preferably Phase I Experience of CDISC standards including SDTM, aCRF, SDRG and define.xml (ADaM and TFLs and advantage) Hands-on experience manipulating data using SAS Excellent written and verbal communication A … your skill set Responsibilities Planning, developing and validating SAS programs · CDSIC SDTM mapping and programming Creation of SDTM, SDRG, define.xml · Review and QC of CDISC related files Ad-hoc programing to support database QC and validation Data interrogation and exploratory data analysis Input into department process improvement, including creating and more »

level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. Develop software systems to generate displays of clinical study data as tables, listings, and … NDAs/BLAs. Experience overseeing the work of internal contractors and external vendors (CROs) Experience in pharmacokinetics/pharmacodynamics modeling a plus Familiarity with CDISC standards, including SDTM and ADaM models Solid verbal and written communication skills Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified more »

level. • Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) • Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. • Develop software systems to generate displays of clinical study data as tables, listings, and … NDAs/BLAs • Experience overseeing the work of internal contractors and external vendors (CROs) • Experience in pharmacokinetics/pharmacodynamics modeling a plus • Familiarity with CDISC standards, including SDTM and ADaM models • Solid verbal and written communication skills Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified more »

to work independently. • Capacity to quickly read late development protocols, understand the statistical methodology, and apply it to clinical data. • Knowledge and practice of CDISC SDTM and ADaM data standards. • Ability to work in compliance with the company Analysis and Reporting SOPs and project data standards. • Able to re-in … Proven experience of work with clinical trial data in support of safety and efficacy analysis • Ability to read, write and speak fluently in English. • CDISC knowledge is required. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be more »

Programming experience within the pharmaceutical industry essential. Excellent knowledge of SAS essential and R or Python. advantageous. Good working knowledge of data structures e.g. CDISC, SDTM, ADaM, Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines Exposure to working with clinical datasets, statistical methodology, and CSR/submission deliverables. more »

the study through to final delivery of clinical datasets. Providing SAS programming support through all phases of the projects along with detailed knowledge of CDISC with experience of mapping and programming SDTM standard datasets is essential. This is a hybrid role and will initially require more office presence, gradually transitioning … planning of assigned projects. Provide hands on technical data management expertise and SAS programming support through all phases of the projects following industry standards (CDISC), from database build through to delivery of mapped datasets. Support projects from both the Clinical Site data perspective, as well as the Data Management vendor … of end to end Clinical trial and Project Data Management processes, as well as extensive experience in the Data Management industry Detailed knowledge of CDISC with experience mapping and programming SDTM standard datasets Flexible and adaptive approach, being able to rapidly re-prioritise whilst maintaining a clear vision, as well more »