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7.0 - 9.0 years
0 Lacs
thiruvananthapuram, kerala, india
On-site
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...
Posted 3 weeks ago
0.0 years
0 Lacs
hyderabad, telangana, india
On-site
About The Job Title: Principal Data Standards Analyst (Laboratory Expert) Level : L2-2 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 interna...
Posted 3 weeks ago
8.0 - 10.0 years
0 Lacs
hyderabad, telangana, india
On-site
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 Principal Biostatistician will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans (SAP), programming specifications for a...
Posted 3 weeks ago
4.0 - 7.0 years
15 - 25 Lacs
mumbai, navi mumbai, mumbai (all areas)
Hybrid
Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. data validation guidelines),Develop SAS programs for ad hoc tables and listings, Required Candidate profile Design and set-up utilities/SAS based systems ,Carry out electronic data transfer (both incoming and outgoing),Review and interpret Report and Analysis Plans, Follow CDISC, FDA & other Guidelines
Posted 4 weeks ago
8.0 - 13.0 years
30 - 40 Lacs
hyderabad
Hybrid
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,...
Posted 1 month ago
2.0 - 12.0 years
0 Lacs
karnataka
On-site
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...
Posted 1 month ago
5.0 - 7.0 years
0 Lacs
india
On-site
Who Are You An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead Phase II-III clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what it is but always push clinical development forward to what it could be. You motivate others to do the same. Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of o...
Posted 1 month ago
0.0 years
0 Lacs
mumbai, maharashtra, india
Remote
Job Overview The RN Associate / Senior Associate, Clinical Data Management is responsible for delivering and overseeing clinical and patient reported data within electronic data capture (EDC) platforms, including iTakeControl. Activities include monitoring databases and video evidence, maintaining data quality, and database integrity for research studies from conception to closeout. The role will work closely with the Clinical Operations, Product Management and Technical Delivery teams and is responsible for detailed specification development, documentation, and supporting clinical operations, project management and delivery activities for Clinical and iTakeControl (iTC) product client proje...
Posted 1 month ago
2.0 - 7.0 years
2 - 5 Lacs
bengaluru
Work from Office
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...
Posted 1 month ago
2.0 - 5.0 years
3 - 6 Lacs
pune
Work from Office
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. ...
Posted 1 month ago
2.0 - 5.0 years
0 Lacs
hyderabad, telangana, india
On-site
Summary The Data Anonymization Analyst is part of the data42 Data Anonymization team and is responsible for anonymization of data sets for data42. A key aspect of the program is to anonymize the data to enable secondary research on data lakes. The position is a key collaborator with other data42 teams. Ensure that data sets are anonymized efficiently with timely and high-quality deliverables for data42 users. This individual will be responsible for anonymizing data from clinical trials, including clinical raw and derived data of the clinical database (RDC, lab and 3rd party data), images, documents and other unstructured data. Use software products to anonymize data sets against, and to miti...
Posted 1 month ago
0.0 years
0 Lacs
hyderabad, telangana, india
On-site
Summary The Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy. They provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including; Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer...
Posted 1 month ago
8.0 - 13.0 years
11 - 16 Lacs
pune
Work from Office
ZS Life Science R&D Technologist in Clinical development ZS life science R&D team partners with clients to discover and develop innovative medicines that improve patient's lives. Our work spans consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professionals that deliver R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in drug development. The Drug Development R&D Technologists possess a deep understanding of technological solution...
Posted 1 month ago
4.0 - 8.0 years
25 - 30 Lacs
pune
Work from Office
Description Principal Stat Programmer SDTM, ADAMs & TLFsConsumer Health Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with pass...
Posted 1 month ago
4.0 - 8.0 years
12 - 17 Lacs
pune
Work from Office
What Youll Do - You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE . You will work on designing safety data mart for cross study analysis and exploratory analysis You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials. You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and e...
Posted 1 month ago
4.0 - 9.0 years
3 - 7 Lacs
pune
Work from Office
Analyze and interpret complex clinical data using SAS. Develop and maintain databases, data systems, and computer models for clinical trial management. Collaborate with cross-functional teams to design and implement data analysis plans. Ensure data quality, integrity, and compliance with regulatory requirements. Provide technical support and training to junior staff members on data analysis tools and techniques. Participate in project meetings and contribute to the development of project plans and timelines. Job Requirements Strong knowledge of SAS programming language and its applications in clinical data analysis. Experience with Veeva or similar clinical trial management systems. Excellen...
Posted 1 month ago
2.0 - 7.0 years
2 - 6 Lacs
mumbai
Work from Office
Design, develop, and implement clinical trial data management systems using SAS. Collaborate with cross-functional teams to ensure seamless integration of clinical data into existing systems. Develop and maintain complex SQL queries to extract insights from large datasets. Troubleshoot issues related to clinical trial data management and reporting. Ensure compliance with regulatory requirements and industry standards. Participate in code reviews and contribute to improving overall code quality. Job Requirements Strong proficiency in SAS programming language, including Base SAS and Enterprise Guide. Experience with SQL programming, particularly in a clinical trial context. Knowledge of clinic...
Posted 1 month ago
3.0 - 6.0 years
3 - 7 Lacs
pune
Work from Office
Design, develop, and implement Veeva EDC clinical programming solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain high-quality code that meets client specifications and industry standards. Troubleshoot and resolve technical issues related to Veeva EDC clinical programming. Participate in code reviews and contribute to improving overall code quality. Stay up-to-date with industry trends and emerging technologies in Veeva EDC clinical programming. Job Requirements Strong understanding of Veeva EDC clinical programming principles and practices. Proficiency in developing complex programs using Veeva EDC tools and te...
Posted 1 month ago
2.0 - 7.0 years
2 - 5 Lacs
mumbai
Work from Office
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 data extraction and manipula...
Posted 1 month ago
2.0 - 7.0 years
2 - 5 Lacs
mumbai suburban
Work from Office
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 to ensure high-quality deliverables. 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. Experience with SQL programming languages, including query design ...
Posted 1 month ago
2.0 - 7.0 years
2 - 5 Lacs
navi mumbai
Work from Office
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 programming and provide technical support. Participate in code reviews and contribute to improving overall code quality. Stay updated with industry trends and emerging technologies in clinical SAS programming. Job Requirements Strong knowledge of clinical SAS programming and SQL. Experience working with CDMS is essential. Excellent problem-solving skills and attention to detail. Ability to ...
Posted 1 month ago
4.0 - 9.0 years
3 - 7 Lacs
mumbai
Work from Office
Roles and Responsibility Analyze and interpret complex clinical data to inform business decisions. Develop and maintain databases, spreadsheets, and reports using SAS and Veeva. Collaborate with cross-functional teams to design and implement data analysis solutions. Ensure data quality, integrity, and compliance with regulatory requirements. Provide technical support and training to junior team members on data analysis tools. Stay up-to-date with industry trends and emerging technologies in clinical data analysis. Job Requirements Strong proficiency in SAS programming language and Veeva software. Experience working with large datasets and performing complex data analysis tasks. Excellent pro...
Posted 1 month ago
3.0 - 6.0 years
3 - 7 Lacs
mumbai
Work from Office
Roles and Responsibility Design, develop, and implement Veeva EDC clinical programming solutions for clients. Collaborate with cross-functional teams to ensure seamless integration of EDC systems. Develop and maintain technical documentation for EDC systems and applications. Troubleshoot and resolve issues related to EDC system performance and data quality. Provide training and support to end-users on EDC systems and applications. Participate in project planning, execution, and delivery to meet client requirements. Job Requirements Strong understanding of IT Service & Consulting principles and practices. Experience working with Veeva EDC clinical programming tools and technologies. Excellent...
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
telangana
On-site
As a Principal Engineer (Data Governance) at Syneos Health, you will play a crucial role in deploying and configuring Microsoft Purview to establish end-to-end data governance for structured and unstructured clinical and healthcare datasets. Your responsibilities will include: - Defining and implementing metadata management frameworks and data stewardship models aligned with HIPAA, GDPR, and internal data privacy policies. - Integrating Purview with Azure Synapse, Databricks, Azure Data Factory, and various production systems for metadata harvesting, lineage tracking, and compliance auditing. - Collaborating with clinical researchers, data scientists, and business analysts to ensure governed...
Posted 1 month ago
3.0 - 6.0 years
3 - 7 Lacs
mumbai
Work from Office
Roles and Responsibility Design, develop, and implement Veeva EDC clinical programming solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain high-quality code that meets client specifications and industry standards. Troubleshoot and resolve technical issues related to Veeva EDC clinical programming. Provide training and support to clients on the use of Veeva EDC clinical programming tools. Participate in the development of best practices and standards for Veeva EDC clinical programming. Job Requirements Strong understanding of Veeva EDC clinical programming principles and methodologies. Experience working with var...
Posted 1 month ago
 
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