Experienced I Statistical Programmer

Integrated Data Analytics and Reporting (IDAR) Experienced Programmer (ST05)(*Title may vary based on Region or Country requirements)

Position Summary:

The Experienced Programmer is an individual contributor with knowledge of data structures, industry standards, programming languages, and programming methods

This role supports data analyses and reporting activities within trial activities in accordance with departmental processes and procedures

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 JJ 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 (eg ICH-GCP) and relevant clinical RD 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: