Experienced I Clinical Programmer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

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