This position is a member of the programming team, capable of supporting programming activities of one or more trials of low to medium complexity/criticality and may contribute to departmental innovation and process improvement projects.
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 of CDISC 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.
Principal Relationships
This role reports into a people manager position within the Delivery Unit and is accountable to the Portfolio and Study Leads for assigned activities and responsibilities.
Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.
Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Regulatory, Strategic Partnerships, Human Resources.
External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups.
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. 2+ 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
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
