Job Title: Clinical Programmer

Job Description

Provide clinical programming expertise to support clinical trials, global filings, regulatory queries, data collection, and cleaning.

Responsibilities

• Provide input from statistical programming to support clinical trials, global filings, regulatory queries, labelling, and payer analyses, as well as scientific communications and publications.
• Offer subject matter expertise to the design of data collection, data cleaning, SAP, and TFL mock shells.
• Collaborate with cross-functional groups to ensure the successful execution of clinical trials.
• Create, validate, or review SDTM, ADaM, and TFLs, mapping specifications, and variable definitions.
• Review CSR analysis outputs and evaluate submission data packages.
• Program, test, and document utility programs and tools per standard procedures.
• Support daily operations, ensuring all assigned project tasks are completed accurately and on schedule.
• Contribute to departmental process development and process improvement.

Essential Skills

• Programming
• Clinical research
• SAS
• Patient Reported Outcomes (PROs)
• Clinical Systems
• Data collection
• Data Cleaning
• Bachelor’s Degree in life science, computer science, engineering, business, or related discipline
• 4+ years of experience in clinical development
• Experience with SDTM and ADaM
• Familiarity with Patient Reported Outcomes (PROs) and common eCOA systems
• Knowledge of good clinical practices, data standards, and regulatory guidance related to PRO and eCOA
• Experience implementing clinical systems such as CTMS, EDC, ePRO or other related technology in the pharmaceutical/biotechnology industry

Additional Skills & Qualifications

• Project management and technical expertise
• Attention to detail
• Excellent documentation and communication skills
• Excellent time management and organization skills
• Sound problem resolution, judgment, and decision-making abilities
• Good team player with a result-oriented attitude and can-do mentality