Job Description

The Clinical Programmer (SDTM)

The Clinical Programmer (SDTM) is primarily responsible for SDTM programming based on Clinical Protocols, eCRF and Statistical Analysis Plans. The Clinical Programmer (SDTM) may also be responsible for data submission packages to clients and regulators. The Clinical Programmer (SDTM) works collaboratively with the project biostatisticians, Statistical Programmers and other project stakeholders to produce quality SDTM outputs based on the eCRF design, clinical protocol and Statistical Analysis Plan.

Responsibilities:

• SDTM Programming and annotation of SDTM CRF.
• SDTM Quality Control, Double Programming and Peer Review.
• Develop Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission.
• Adhere to company statistical programming standards, conventions, and data standards.
• Ensure that SAS programs are properly documented and traceable.
• Maintain study documentation, programs and files within project files.
• Maintain timesheets.
• Participate in department meetings.

Additional Responsibility for Senior Clinical Programmer (SDTM):

• Contribute to developing company programming conventions and SAS macros.
• Assess impact of new software releases and patches of SAS on ongoing projects.
• Automate statistical programming tasks and progress tracking.
• Advise Clinical Data Management and Clinical Data Programming with respect to CRF libraries and data dictionaries based on CDASH and SDTM.
• Contribute to the development and updating of SOPs.
• Implement best practices, process improvement, quality control and governance related to all statistical programming matters.
• Resource planning and forecasting.
• Develop training materials, train and mentor Junior Staff.
• Participate in audits.
• Represent company at client meetings as required.

Additional Responsibility for Principal Clinical Programmer (SDTM):

• Act as SME, representing company in project meetings and client meetings.
• Monitor compliance with applicable regulatory agency guidelines and company corporate policies and SOPs.
• Estimate costs in consultation with Line Manager.
• Take a lead role in the development and updating of SOPs and best practices.
• Drive initiatives, task automation, process improvement, quality control and governance related to all statistical programming matters.
• Select and evaluate new software tools in consultation with the Line Manager.
• Contribute to infrastructural (non-clinical) process improvement initiatives.
• Participate in industry forums (conferences, professional association committee work etc.)
• Share industry forum related topics to the Biostatistics and Clinical Programmer teams, and wider organisation.
• Provide guidance on applicable regulations to the Clinical Programmers, biostatisticians and other internal and external stakeholders.
• Provide guidance on data submission packages to regulators as part of an IND or NDA.

Education:

• Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or Quantitative/Analytical fields.

Knowledge, Skills, and Abilities:

• SAS
• SDTM Programming
• Clinical Protocols and Statistical Analysis Plans
• Organizational Skills

Experiences:

• SAS Programming Experience.
• Experience in Pharmaceutical industry, CRO or related experience.

Additional Requirements for Senior Clinical Programmer (SDTM):

• Advanced SDTM programming on most domains (LAB, PC, PP, etc.)
• Strong organizational and communication skills.

Additional Requirements for Principal Clinical Programmer (SDTM):

• Subject Matter Expert (SME) on advanced SDTM programming domains.
• SME on Industry Best Practices and Standards.
• SME on Quality Assurance best practices.