Experienced 1 Statistical Programmer

The Senior Statistical Programmer Analyst is an individual contributor with in-depth knowledge of statistical programming methods, languages and data structures who supports data analysis and reporting activities within the Statistical Programming functional area in accordance with departmental processes and procedures. This position is accountable for the development, verification, and documentation of code used for the analysis and reporting of clinical data and is responsible for the timeliness and the quality of assigned deliverables supporting clinical projects and submissions. This position is a member of a programming team, capable of supporting programming activities of medium to high complexity with minimal guidance. In addition, the Senior Statistical Programmer Analyst may contribute to departmental innovation and process improvement projects.

Principal Responsibilities:

• Designs and develops statistical programs in support of clinical research analysis and reporting activities.
• Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities.
• Maintains statistical programming documentation as appropriate.
• Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.
• Performs activities in compliance with departmental processes and procedures.
• Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals.
• Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables.
• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.
• May contribute to departmental innovation and process improvement projects.

Principal Relationships:

• Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities
• Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical - Primary interfaces within clinical project (trial), program, and submission teams.
• External contacts include but are not limited to external partners including CROs.

Qualifications

• Bachelor s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth).
• Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical RD environment or field.
• In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred.
• Working knowledge of processes and concepts relevant to Statistical Programming.
• Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical RD concepts.
• Demonstrated written and verbal communication skills.
• Experience working in a team environment.