619 Sdtm Jobs - Page 6

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...

Job Overview Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective. Essential Functions Interprets the study protocol. Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable. Create and update Edit Specification Document. Generate specifications for E...

38245BR Bangalore - Campus Job Description TECHNICAL SKILLS Demonstrated experience enterprise cloud data engineering, design, and data management techniques and principles related to data warehousing, operations data stores, data marts, data lake design, and other emerging technologies. Proven expertise in designing and orchestrating batch and real-time data ingestion workflows using Azure Data Factory (ADF) and other ETL tools such as Informatica IICS, Snowflake, AWS Glue etc. Hands-on expertise in building, testing, deploying, and monitoring scalable ETL/ELT pipelines using Azure Data Factory and related Azure services. Proficient in data pipelines troubleshooting, development of triggers...

About the Role: We are seeking a compassionate and dependable Patient Care & Support professional to assist patients with daily activities and ensure a comfortable, safe, and healing environment. You will work under the supervision of registered nurses and medical staff to provide direct care and emotional support to patients in a healthcare setting. Key Responsibilities: Measure and record vital signs (temperature, pulse, blood pressure, respiration) Collect samples for lab tests (under supervision) Monitor patient behavior and report changes to nurses or doctors Assist in preparing patients for examinations or procedures Maintain logs of patient care activities and vital signs Report unusu...

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...

About The Job Our Team: Sanofi Global Hub 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 Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Senior Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Global Hub biostatistics and programming personnel to implement (Develop and/or QC) statistical analysis plans(SAP), programming specifications for analysis dat...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

TOP Skills: SDTM Programming SQL DB Understanding Job Description: Responsibilities: -Under general supervision, conducts mapping of SDTM and Custom domains. -Understands and reviews requirements, creates plans and/or contributes in estimations. -Performs planning, mapping domains, review domains and Unit testing on planned releases. -Supports and performs defect fix and tracking; coordinates with team. -Works closely with testers, Dev Leads/Managers and other project stakeholders. -Maintains documentation to assist in debugging and modifying software; analyzes results to ensure existing functionality and recommends corrective action. -Coordinates with testing teams in troubleshooting and re...

TOP Skills: SDTM Programming SQL DB Understanding Job Description: Responsibilities: -Under general supervision, conducts mapping of SDTM and Custom domains. -Understands and reviews requirements, creates plans and/or contributes in estimations. -Performs planning, mapping domains, review domains and Unit testing on planned releases. -Supports and performs defect fix and tracking; coordinates with team. -Works closely with testers, Dev Leads/Managers and other project stakeholders. -Maintains documentation to assist in debugging and modifying software; analyzes results to ensure existing functionality and recommends corrective action. -Coordinates with testing teams in troubleshooting and re...

Role Overview: At EY, you will have the opportunity to shape a unique career tailored to your strengths, with the necessary global support, inclusive environment, and advanced technology to help you reach your full potential. Your distinct voice and perspective are crucial in contributing to EY's continuous improvement. By joining us, you will not only create a remarkable experience for yourself but also contribute to building a better working world for all. Key Responsibilities: - Drive consulting engagements focused on clinical data transformation, including SDTM mapping, CDASH adoption, and standards harmonization. - Lead client workshops, diagnostic assessments, and solution design initi...

About the Role We are seeking a highly skilled Senior Statistical Programmer to join our growing Biometrics team. The ideal candidate will be responsible for providing advanced programming support for the analysis and reporting of clinical trial data in compliance with regulatory requirements. This role will involve working closely with Biostatisticians, Data Managers, and Clinical Teams to deliver high-quality datasets, tables, listings, and figures (TLFs). Key Responsibilities Develop, validate, and maintain SAS programs to generate analysis datasets (ADaM, SDTM) and TLFs for clinical trial submissions. Ensure programming deliverables are accurate, efficient, and compliant with CDISC stand...

Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan,...

Key Responsiblities Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Strong proficiency implementing the latest CDISC SDTM / ADaM standards. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) Develop and review SAS programs for data analysis, tables, figures, and listings, and ensure accuracy and consistency of data output Qualifications: Bachelor’s or Master’s degree in a data science field, e.g., statistics, ma...

As a Clinical Data Manager in the pharmaceutical and life sciences industry, your role involves overseeing the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures, ensuring compliance with regulations and protocols, and maintaining the highest data quality standards throughout the data lifecycle. Your key responsibilities include: - Overseeing the collection, validation, and processing of clinical trial data. - Developing and implementing data management procedures for clinical trials. - Supporting and facilitating the review of medical coding for validity and completeness. - Ensuring compliance wit...

ISS Statistical Programmer II India ICON plc is a world-leading healthcare intelligence and clinical research organization Were 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, We are currently seeking a Statistical Programmer II to join our diverse and dynamic team As a Statistical Programmer II at ICON, you will play a vital role in the development, validation, and execution of statistical programs to support clinical trial analysis and reporting Your expertise will contribute to the accurate interpretation of clinical data, helping to ensure the successful delivery of resea...

You will be contributing as a product expert, analyzing and translating business needs into long-term solution data models. You will be evaluating existing data systems and working with the development team to create conceptual data models and data flows. You should understand the distinctions between out-of-the-box configurations, customizations of base software product platforms, as well as considerations for performance, scalability, and usability. Your responsibilities will include developing and maintaining data ingestion, data analysis, and reporting solutions for Clinical data. You will collaborate with cross-functional teams to identify and solve complex data-related problems. Additi...

Project Role: Programmer Work Experience: 2 to 12 Years Work location: Bengaluru. Work Mode: Hybrid Must Have Skills: SDTM, CDISC ,Python Key Responsibilities Contributing as a product expert, analyzing and translating business needs into long-term solution data models. Evaluating existing data systems and working with the development team to create conceptual data models and data flows. Understands what is out of the box vs. configuration vs. customization of base software product platforms, as well as performance, scalability, and usability considerations. Develop and maintain data ingestion, data analysis, and reporting solutions for Clinical data Collaborate with cross-functional teams t...

The Senior Biostatistician is responsible for leading, developing, implementing, and overseeing statistical strategies and deliverables in support of the Client’s R&D sponsored clinical trials. Under the guidance of Head of Biostatistics, this role contributes to the planning, execution and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards. Essential Functions Serve as biostatistics leader for assigned studies and projects Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation Author and review Statistical Analysis...

ISS - Statistical Programmer II - India 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. We are currently seeking a Statistical Programmer II to join our diverse and dynamic team. As a Statistical Programmer II at ICON, you will play a vital role in the development, validation, and execution of statistical programs to support clinical trial analysis and reporting. Your expertise will contribute to the accurate interpretation of clinical data, helping to ensure the successful delivery ...

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Principal Statistical Programmer (“Programmer”) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for pro...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Roles and Responsibility Analyze and interpret complex clinical trial data to identify trends and patterns. Develop and maintain databases and systems for managing clinical trial data. Collaborate with cross-functional teams to ensure accurate and timely delivery of data. Conduct quality control checks on data to ensure accuracy and integrity. Provide insights and recommendations to stakeholders based on data analysis. Stay up-to-date with industry developments and best practices in clinical data analysis. Job Requirements Strong understanding of clinical trial design, protocols, and statistical analysis plans. Proficiency in database management systems such as SQL or Oracle. Experience with...

Roles and Responsibility Design, develop, and implement clinical SAS programs for data management and analysis. Collaborate with cross-functional teams to identify business requirements and develop solutions. Develop and maintain complex SQL queries for data extraction and manipulation. Troubleshoot issues related to clinical SAS programs and provide technical support. Participate in code reviews and ensure adherence to coding standards. Stay updated with industry trends and emerging technologies in clinical SAS and SQL programming. Job Requirements Strong knowledge of clinical SAS programming language and its applications in data management and analysis. Expertise in SQL programming for dat...

Roles and Responsibility Design, develop, and implement clinical trial data management systems using SAS. Collaborate with cross-functional teams to ensure timely delivery of high-quality results. Develop and maintain complex statistical analysis plans and programs. Troubleshoot and resolve technical issues related to clinical trial data management. Ensure compliance with regulatory requirements and company standards. Participate in project planning, execution, and reporting activities. Job Requirements Strong knowledge of SAS programming language and its applications in clinical trial data management. Experience working with large datasets and developing complex statistical analysis plans. ...