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Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Biostatistics
Job Category:
Scientific/Technology
All Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India
Job Description:
Experienced I Clinical Programmer - SDTM Programmer:
As an experienced programmer, reviews specifications for mapping raw data to SDTM, annotate aCRF, perform dataset validation, create Define etc.,
• Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM.
• Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring
Principal Responsibilities:
• Completes and may lead programming trial activities of low to medium complexity and/or criticality, with high quality and timeliness of deliverables.
• Accountable for the design and development of programs in support of clinical research analysis and reporting.
• Performs appropriate level of verification of programming and reporting activities. Reviews and provides input for project requirements and documentation.
• Supports submission activities including but not limited to creation, verification, and delivery ofCDISC compliant and/or non-standard data packages and reviewer’s guides.
• Follows departmental processes and procedures, ensures use of latest standards and deployment of current technologies.
• May contribute to departmental innovation and process improvement projects.
• Collaborates effectively with team and cross-functional members.
• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position
Education and Experience Requirements:
Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics, public health, or another relevant scientific field (or equivalent theoretical/technical depth).
Experience and Skills Required:
• Approx. 4+ years of relevant programming experience, preferably in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Basic knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.
• Experience working in a team environment preferred.
• Excellent written and verbal communications skills.
• Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. May include SAS, R, Python, etc. SAS knowledge is preferred for Clinical Programming role.
• Basic knowledge of processes, methods, and concepts relevant to programming.
Required Skills:
Clinical SAS Programming, SDTM Mapping, Study Data Tabulation Model (SDTM)
Preferred Skills:
Advanced Analytics, Analytical Reasoning, Biological Sciences, Biostatistics, Clinical Trials, Data Modeling, Data Privacy Standards, Data Quality, Data Savvy, Detail-Oriented, Good Clinical Practice (GCP), Report Writing, Research Ethics, Researching, Statistical Analysis Systems (SAS) Programming, Statistics, Technologically Savvy
