271 Cdisc Jobs - Page 3

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all wri...

- Understand and follow study start-up, conduct, and close out activities per the standard process, which will be made known to Service Provider and to the Data Manager in advance and in writing by Baxter. - Act as a single point of contact from the Service Provider for the studies as assigned - Prepare/review eCRFs, Edit checks, and Custom Functions requirement document - Prepare or review edit checks requirement and functional test script document - Perform functional testing for eCRF/edit checks and Custom Functions - Identify reports and DM Tables requirements and prepare a report specification document - Review and provide feedback for study conduct activities performed by the Service P...

- Understand and follow study start-up, conduct, and close out activities per the standard process, which will be made known to Service Provider and to the Data Manager in advance and in writing by Baxter. - Act as a single point of contact from the Service Provider for the studies as assigned - Prepare/review eCRFs, Edit checks, and Custom Functions requirement document - Prepare or review edit checks requirement and functional test script document - Perform functional testing for eCRF/edit checks and Custom Functions - Identify reports and DM Tables requirements and prepare a report specification document - Review and provide feedback for study conduct activities performed by the Service P...

- Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing educatio...

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all wri...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Data Modeler will work on projects to define and develop logical and physical data models that satisfy Parexel’s financial and operational reporting, a...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Data Modeler will work on projects to define and develop logical and physical data models that satisfy Parexel’s financial and operational reporting, a...

Role Overview: As a Statistical Programmer at Statistics & Data Corporation (SDC), your primary responsibility will be to provide statistical programming support for clinical trials. This includes generating and validating analysis datasets, tables, listings, and figures for clinical trials, creating SDTM mapping and datasets, and maintaining the infrastructure for project files of SAS datasets and SAS code. You will collaborate with Data Management on data set creations/transfers, integrity checks, and quality audits, and act as a liaison between clinical subcommittees and project teams as needed. Key Responsibilities: - Performing statistical programming for clinical trial analysis and rep...

Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate...

Location - Chennai ( Client location) Budget - 22L Experience- 8+yrs SO - 54925613 Open Position - 5 SAS Developer - 7+ years of experience as a SAS (Statistical Analysis Software) Programming Hands-on experience with BASE SAS, SAS/MACRO, SAS/STAT; Knowledge on CDISC Standards (must require SDTM and ADaM) Analysis & Reporting end to end process (must require TFLs generations as per sponsor standards) Expert in Relational Database systems (Oracle preferred) Advanced knowledge of software development lifecycle methodologies Strong understanding of importance of coding standards and programming style. Advanced ability to write software code (full stack development). Responsibilities Designs, mo...

The Clinical Database Programmer is primarily responsible for LSH Setup and Data Loading activities (both Inbound and Outbound) with External Data providers Also provide support to manage the load, Transfer and conform Clinical Trial Data to Novartis Internal standards and the provision of Clinical Data extracts to Clinical Data Consumers of study-level or project level deliverables under minimal guidance About The Role Major accountabilities Contribute to LSH and Data Loading activities as Clinical Database Programmer for phase I to IV clinical studies in Novartis Global Drug Development Participate in the review of Data Transfer specification documents and provide comments if required Resp...

Assist in the timely & professional ongoing Mgmt of data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team Ensure high quality data available for secondary analysis use Support content development and upgrade to training modules into engaging and interactive applications Follows data regulations and laws, data-handling procedures and data mapping guidelines Supports quality deliverables within Clinical Data Operations (DO) Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical Data Warehouse...

As a Senior Statistical Programmer at Tech Observer, a global Clinical Research Organization (CRO) and Functional Service Provider (FSP), your role will involve the following key responsibilities: - Ensure compliance with working SOPs, Quality Management System, and Good Clinical Practice (GCP), while adhering to programming guidelines. - Implement and follow the latest versions of CDISC, FDA Guidelines, GCP, and other industry standards. - Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures, and study-related documentation. - Review and interpret Report and Analysis Plans, providing comments for assigned projects...

Summary Of Responsibilities Perform the role of the Lead Statistical Programmer. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc. Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs. Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client ...

Principal Clinical Data Standards Consultant _ Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Are you an expert with practical experience in CDISC and CDASH standards Do you have build/design experience in Medidata Rave EDC and/or Veeva Clinical Data (Vault CDMS/EDC) If so, join our diverse and dynamic team at ICON as a Principal Clinical Data Standards Consultant! As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in the development and implementat...

About The Job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC'd data packages incl...

Role Overview: As a Senior Clinical Data Programmer, your core responsibility is to understand complex business requirements and identify strategic opportunities to drive efficiency and value through data. You will leverage advanced programming languages, scripts, and software tools to perform sophisticated data extraction, transformation, and validation, ensuring the highest standards of data integrity and consistency across critical projects. Key Responsibilities: - Architect and maintain complex programs, ensuring robust data integrity and accuracy. - Create advanced programs for generating detailed reports and summaries of clinical trial data. - Design and implement advanced software to ...

The Principal Data Standards Analyst (Laboratory Expert) plays a crucial role in ensuring the accurate standardization, integration, and management of laboratory data across clinical studies. This role supports Clinical Information Governance (CIG), Trial Operations (TO) , Data integration, Translational Medicine, Sample Management, and external vendors, ensuring compliance with CDISC standards (SDTM, CDASH, Controlled Terminology) and regulatory requirements. The Principal Data Standards Analyst (Laboratory Expert) also provides specialized oversight on laboratory data handling, collaborating with internal teams and external central laboratories to mitigate risks related to biomarker, genom...

Purpose The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management). Key Responsibilities The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs. Technical: Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs Author, review and approve study TFL shells and dataset specifications Author, validate and document SAS programs for datasets, TFLs and macros, applying goo...

Manager, CSAR - Global Library What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Companys standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The positio...

What you will do The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization. The AVP will lead Amgens Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, ...

What you will do Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As Sr. Director of Statistical Programming, you will provide local functional leadership from AIN, supporting global clinical development programs in close partnership with global teams through seamless execution that leverages digital innovation to drive quality deliverables, operational excellence, and regulatory compliance. Responsibilities: Provide strategic and operational leadership for statistical programming delivery within Amgens global framework, with site accountability based in AIN. Oversee the execution o...

Role Overview: As a Senior Statistical Programmer, you will be providing advanced technical expertise to develop process methodology for the department to meet internal and external client needs. Your role will involve planning and coordinating the development of integrated programming solutions to cater to the full spectrum of statistical programming needs. Your leadership and technical expertise will be crucial in providing internal consulting services, including specifications and user needs analysis for complex projects or client requirements. Key Responsibilities: - Perform, plan, coordinate, and implement programming, testing, and documentation of statistical programs for creating stat...

As a Senior Statistical Programmer / Principal Statistical Programmer with 5+ to 12 years of experience in Bangalore, you will play a crucial role in developing specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis (CDA configuration) module in elluminate. Your primary skills should include SDTM, ADAM, TLF, CDISC, and Study lead experience. The key responsibilities of your role will involve developing SAS programming to produce SDTM datasets and SDTM datasets for CDA configuration, as well as developing specifications for Analysis Data Model (ADaM) datasets and SAS programming for ADaM datasets. Additionally, you will be responsible for developing and m...

Position Summary: The Principal Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. The Principal Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, the Principal Statistical Programmer will write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. The Principal Programmer will assume a leadership role on multiple complex projects, direct and/or mentor programmers at more junior levels a...