Principal Clinical Programmer

Job Title:Principal Clinical Programmer
Job Code: CDM0015
Department Name: Clinical Data Management
Reports to Title: Associate Manager or above
Job Summary:
The Principal Clinical Programmer involves advanced and strategic responsibilities in the development and management of clinical trial data systems. The position requires a seasoned expert in clinical data systems, programming, and analytics, offering leadership in ensuring the highest standards of data integrity and efficiency in clinical trials.
Responsibilities:

• Lead the design, development, and maintenance of software applications, utilizing advanced programming languages such as SAS, SQL, and EDC tools (e.g., Medidata Rave, Veeva CDMS, Oracle ClinicalOne).
• Drive the development and implementation of innovative programming strategies to optimize clinical data management processes.
• Serve as the primary liaison between the data management team and other departments, including biostatistics, regulatory affairs, and IT.
• Mentor and provide technical guidance to junior Clinical Programmers globally, fostering a culture of continuous learning and development within the team.
• Oversee the creation and implementation of data standards (e.g., CDISC) across various clinical studies, ensuring compliance with regulatory requirements.
• Lead the validation and quality assurance processes for clinical databases, ensuring accuracy, consistency, and reliability of data.
• Manage the programming aspects of complex clinical trials, including multicenter and multinational studies.
• Spearhead initiatives to evaluate and implement new technologies and methodologies in clinical programming.
• Collaborate with project management to ensure timely delivery of programming deliverables, aligning with study timelines and milestones.
• Represent the data management team in client meetings, audits, and regulatory inspections, providing expert knowledge and support.

Experience:

• Minimum of 5-7 years' experience in clinical programming within a CRO, pharmaceutical, or biotech environment.
• Advanced expertise in programming languages such as SAS, SQL, R, Python, Julia.
• Strong experience with EDC systems, CDISC standards, and global clinical trial processes.
• Demonstrated leadership skills with the ability to manage and mentor a team of programmers.
• Exceptional problem-solving abilities and meticulous attention to detail.

Education/Qualifications:

• University / college degree (information technology, life sciences, or related subjects) preferred.
• Experience and/or education plus relevant work experience will be accepted.

Language Skills Required:

• Speaking: English (Required)
• Writing/Reading: English (Required)