Clinical Programmer II

Clinical Programmer II

Location: Warsaw, hybrid work - 3 days from the office per week

Clinical Programmer II is primarily responsible for providing support to activities related to programming, dashboard development and validation of data cleaning and review listings for ongoing clinical studies with Medium to High Complexity. Clinical Programmer will act as a contributor in cross-functional initiatives. This role works under the general direction of an experienced programmer.

Typical Accountabilities:

• Responsibilities include (but not limited to) design, development, implementation and validation of programs created in SAS/Python/R/SQL or dashboard applications such as PowerBI/Spotfire/MicroStrategy, to process, analyze and report clinical trial data for review by clinical study teams.
• Works towards the design, development, implementation, and validation of PowerBI dashboard applications
• Programs independently with efficiency and quality to process, analyze and report clinical trial data for review by clinical study teams
• Contribute to design, develop and implement Medium to High Complexity projects that are part of clinical programming roadmap
• Collaborates with various teams including data management, development operations, clinical, biometrics and other relevant multi-functional teams supporting clinical trials to deliver end user reporting needs
• Develop and maintain data visualization tools including requirements gathering, design, data provisioning, building dashboards, leading validation/testing activities and providing training Build and maintain catalogue of reports to aid data cleaning activities
• Works within established frameworks and ensures high quality is built into own deliverables.
• Works independently for well-defined scope of work
• Under guidance, creates catalogue of reports to aid data cleaning activities with moderate to medium scope and complexity, but not limited to:

o Automate manual checks

o Automate reconciliation and program edit checks for TPV data to ensure quality

o Create tools and repository to minimize data errors at source for collection of lab reference ranges

o Program Operational reports such missing pages, Open/Closed Quires/ PI signature, Audit Trail reports and detect errors at Subject level.

o Create reports to measure metrics that can help assess data cleaning status

o Create visualizations and dashboards to identify discrepancies in EDC and TPV data

• Maintain created catalogue of reports and perform any updates based on ongoing changes to requirements
• Provide support as required to ensure availability and performance of developed reports and dashboards for both external and internal users
• Responsible for completion of documentation associated with programming tasks (e.g. peer review, reports specifications etc.) in compliance with applicable SOPs
• Proactively keeps the lead programmers updated on progress of deliveries
• Contribute to implementation of cross-functional projects that are part of clinical programming roadmap

Education, Qualifications, Skills and Experience

Essential:

• Bachelor’s degree or equivalent in computer science, life science or statistics
• Good programming skills and Prior experience in SAS/Python/R/SQL/Power BI/ SpotFire and other dashboard technologies
• Basic knowledge of clinical development process
• Good Dashboard development skill in PowerBI / Spotfire
• Basic Knowledge on data capture, data models, data mining.
• Excellent written and verbal communication skills.
• Ability to work in a global team environment.
• Good analytical skills and high attention to detail

Desirable:

• Knowledge of industry standards
• Basic knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes
• Prior Experience and understanding of EDC systems like Medidata Rave / Inform / Veeva/ Saama/ Entimice, SAS LSAF etc
• Knowledge on MicroStrategy