Statistical Programmer
15 hours ago
Data Analysis: Collaborate with cross -functional teams to perform data analysis for phase I to IV clinical studies. Implement statistical programming solutions to support these studies effectively.Data Review: Review electronic Case Report Forms (eCRF) and engage in discussions about data structures.Ensure that data review activities adhere to company, department, and industry standards (e.g., CDISC).Professionalism and Training: Maintain a high level of professionalism, performance, productivity, and quality. Undergo Regulatory trainings, including ICH GCP and 21 CFR Part 11 trainings, to stay updated with industry standards. Study Documents and Training: Read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells, etc.). Complete Project Specific Trainings and maintain appropriate documentation.Data Annotation and Review: Annotate eCRF using Dataset specifications and create annotated CRF (aCRF). Review CRF annotations for protocol compliance and data consistency.Programming and Data Management: Develop user -specific Edit check programs to ensure data quality. Identify and document data issues through appropriate trackers and report to the Lead Programmer. Develop SAS programs/macros, templates, and utilities for data cleaning and reporting when necessary. Perform Reconciliation of External data.Dataset Development: Develop CDISC compliant datasets (SDTM/ADaM) using the Dataset specifications. Create Annotated Mock shells if required. Develop tables, listings, and graphs using Mock shells.Quality Control and Compliance: Be responsible for all Statistical Programming activities, including Self -Validation checklists. Ensure that all tabulation/analysis datasets are compliant with CDISC/client standards. Verify the compliance of all programs with SOPs and project -specific guidelines. Perform First Time Quality Control on reports created.Communication and Collaboration: Provide SAS programming support for Data Management when required. Communicate effectively with the Lead Programmer regarding daily assigned tasks and study -related questions. Maintain clear and proactive communication with project teams to clarify requirements and specifications.Mentorship and Development: Support junior programmers working on the project and assist in their training requirements. Actively engage in self -learning and development in department -specific skill sets.Regulatory Compliance and Audits: Support/assist in audit -specific requirements for internal/external audits. Ensure that all activities are performed in accordance with GCP -ICH guidelines.Other Responsibilities: Contribute to process improvement initiatives. Provide advanced technical expertise and work under minimal supervision to support various programming activities. Forecast work for the team and provide a vision of ongoing project objectives/milestones. Perform other duties as assigned by the Line Manager/HOD.All your contributions will be carried out in strict accordance with GCP -ICH guidelines, reaffirming our commitment to quality and regulatory compliance in every endeavour. RequirementsEducational Background: Bachelor's, Master's, or international equivalent degree in statistics, computer science, mathematics, life sciences, or a related field.
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Bengaluru, India Tata Consultancy Services Full timeJob Description TCS is hiring Statistical Programmer Skill - Statistical Programmer Job Location PAN India Experience Range 3 to 12 Years Educational Qualification(s) Required Graduate/Postgraduate (Any life-science/ Engineering) Required Skillsets: 1. Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses 2....
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bangalore, India ACL Digital Full timeSenior Statistical Programmer (6-8 years of exp) LOOKING FOR IMMEDIATE JOINERS / SERVING NOTICE PERIOD Location : CHENNAI / BANGALORE / HYDERABAD Mode : Onsite / Hybrid ROLES and RESPONSIBILITIES: Perform statistical programming review of case report forms (CRFs), annotated CRFs, database structures, statistical analysis plan (SAP) project documentation such...
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India Novotech Asia Full timeThe Statistical Programmer II is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical Programmers and/or Statistical Programming Management. The SP II works closely with the project biostatisticians and other project stakeholders to plan and assist with...
