Clinical Data Programmer SAS II - CDPSAS

Brief Position Description:

The Clinical Data Programmer SAS II (CDP SAS) is responsible for data analysis and business intelligence activities related to study related clinical and operational data for the purpose of facilitating clinical data inspection and quality control, as well as operational performance control of clinical sites by creating reports, visualisations and dashboards for Clinical Data Managers (CDM), Clinical Data Reviewers (CDR), Project Managers (PM) and other clinical study stakeholders.

Minimum Qualifications & Experience:

A graduate qualification in computer science, data science, mathematics, life sciences or a related field. A minimum of two years’ relevant experience in statistical programming, business intelligence, data analysis or data science within a pharmaceutical company, CRO or EDC software provider. Practical experience using SAS and/or business intelligence tools (e.g. TIBCO Spotfire, Power BI), to interrogate clinical, laboratory or operational datasets is required. Exposure to additional analytics, RBQM, centralised monitoring or workflow automation platforms is desirable.

Responsibilities:

The Clinical Data Programmer SAS II (CDPSAS) partners with clinical study teams and other stakeholders to define, develop, validate, deploy and maintain fit-for-purpose programming and analytics solutions, including dashboards, graphs, tables, listings and reports.

1. Project/Clinical Studies

• Partner with CDMs, CDRs, PMs and other study stakeholders to define clinical, laboratory, external and operational data requirements and recommend fit-for-purpose dashboards, visualisations, listings and reports.

• Manage assigned programming deliverables from requirements gathering and specification through development, testing, deployment, maintenance and change control in accordance with applicable procedures.

• Extract, integrate, transform and analyse clinical study data from EDC, laboratory, operational and other sources using SAS and relevant technologies.

• Develop validated, reusable programs and analytical outputs that support data inspection, reconciliation, clinical and medical review, operational oversight and timely study decision-making.

• Develop and maintain analytics supporting risk-based quality management and centralised monitoring, including key risk indicators, quality tolerance limits, site performance oversight and identification of meaningful data trends and quality signals.

• Perform quality control, peer review and troubleshooting of programming deliverables, and ensure programs are appropriately validated across development, user acceptance testing and production environments.

• Conduct review sessions, present outputs and analytical findings to study stakeholders, and provide training to support effective use of the solutions.

• Maintain complete, accurate and inspection-ready project documentation, and complete timesheets and other assigned administrative responsibilities in a timely manner.

2. Clinical Data Visualisation Team

• Participate actively in Clinical Data Visualisation team, project and Biometrics department meetings.

• Share technical knowledge, contribute to team learning and support the development of less-experienced colleagues.

• Collaborate effectively across functions to support consistent, high-quality study delivery.

3. Software Tools

• Maintain proficiency in SAS and relevant business intelligence, clinical data visualisation, data review and analytics technologies.

• Evaluate and apply fit-for-purpose technologies such as Power BI, Spotfire, Medidata Clinical Data Studio, CluePoints, SQL, Python, R and workflow automation tools, according to project and business needs.

• Develop reusable templates, macros, standard programs and automated solutions that improve quality, consistency, scalability and delivery efficiency.

• Contribute validated programs and outputs to controlled, searchable libraries in accordance with applicable governance requirements.

4. Clinical Data Visualisation Processes and SOPs

• Ensure deliverables comply with Novotech corporate SOPs, applicable regulatory guidelines, validation requirements, data integrity principles and quality control standards.

• Prepare and maintain clear user requirements, specifications, test evidence and other documentation necessary to support validated and inspection-ready solutions.

• Apply approved procedures, best-practice instructions and templates for clinical data programming, analytics and visualisation activities.

• Contribute to SOPs, templates, technical standards, guidance documents, process improvement, quality control and governance initiatives.

   

  Attributes and Skills:

• Good knowledge of clinical study data structures, EDC database schemas and clinical data review processes.

• Strong knowledge of data processing activities, including extracting, integrating, transforming, analysing and presenting data.

• Practical programming capability in SAS; experience with SQL, Python, R or similar languages is desirable.

• Working knowledge of one or more data visualisation and analytics platforms, such as Spotfire, Power BI, Tableau or Qlik.

• Experience with RBQM and centralized monitoring platforms, such as Medidata Clinical Data Studio (CDS) and CluePoints. 

• Experience with clinical data review, reporting, and workflow automation tools, such as JReview and Power Automate.

• Experience gathering business and user requirements from multiple stakeholders and translating them into clear, fit-for-purpose analytical solutions.

• Awareness of regulatory and compliance requirements, with the ability to apply SOPs, validation practices and quality control principles to daily activities.

• Excellent analytical, communication, stakeholder engagement and problem-solving skills, with the ability to work independently and collaboratively.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Responsibilities:

The Clinical Data Programmer SAS II (CDPSAS) partners with clinical study teams and other stakeholders to define, develop, validate, deploy and maintain fit-for-purpose programming and analytics solutions, including dashboards, graphs, tables, listings and reports.

1. Project/Clinical Studies

• Partner with CDMs, CDRs, PMs and other study stakeholders to define clinical, laboratory, external and operational data requirements and recommend fit-for-purpose dashboards, visualisations, listings and reports.

• Manage assigned programming deliverables from requirements gathering and specification through development, testing, deployment, maintenance and change control in accordance with applicable procedures.

• Extract, integrate, transform and analyse clinical study data from EDC, laboratory, operational and other sources using SAS and relevant technologies.

• Develop validated, reusable programs and analytical outputs that support data inspection, reconciliation, clinical and medical review, operational oversight and timely study decision-making.

• Develop and maintain analytics supporting risk-based quality management and centralised monitoring, including key risk indicators, quality tolerance limits, site performance oversight and identification of meaningful data trends and quality signals.

• Perform quality control, peer review and troubleshooting of programming deliverables, and ensure programs are appropriately validated across development, user acceptance testing and production environments.

• Conduct review sessions, present outputs and analytical findings to study stakeholders, and provide training to support effective use of the solutions.

• Maintain complete, accurate and inspection-ready project documentation, and complete timesheets and other assigned administrative responsibilities in a timely manner.

2. Clinical Data Visualisation Team

• Participate actively in Clinical Data Visualisation team, project and Biometrics department meetings.

• Share technical knowledge, contribute to team learning and support the development of less-experienced colleagues.

• Collaborate effectively across functions to support consistent, high-quality study delivery.

3. Software Tools

• Maintain proficiency in SAS and relevant business intelligence, clinical data visualisation, data review and analytics technologies.

• Evaluate and apply fit-for-purpose technologies such as Power BI, Spotfire, Medidata Clinical Data Studio, CluePoints, SQL, Python, R and workflow automation tools, according to project and business needs.

• Develop reusable templates, macros, standard programs and automated solutions that improve quality, consistency, scalability and delivery efficiency.

• Contribute validated programs and outputs to controlled, searchable libraries in accordance with applicable governance requirements.

4. Clinical Data Visualisation Processes and SOPs

• Ensure deliverables comply with Novotech corporate SOPs, applicable regulatory guidelines, validation requirements, data integrity principles and quality control standards.

• Prepare and maintain clear user requirements, specifications, test evidence and other documentation necessary to support validated and inspection-ready solutions.

• Apply approved procedures, best-practice instructions and templates for clinical data programming, analytics and visualisation activities.

• Contribute to SOPs, templates, technical standards, guidance documents, process improvement, quality control and governance initiatives.

• Good knowledge of clinical study data structures, EDC database schemas and clinical data review processes.

• Strong knowledge of data processing activities, including extracting, integrating, transforming, analysing and presenting data.

• Practical programming capability in SAS; experience with SQL, Python, R or similar languages is desirable.

• Working knowledge of one or more data visualisation and analytics platforms, such as Spotfire, Power BI, Tableau or Qlik.

• Experience with RBQM and centralized monitoring platforms, such as Medidata Clinical Data Studio (CDS) and CluePoints. 

• Experience with clinical data review, reporting, and workflow automation tools, such as JReview and Power Automate.

• Experience gathering business and user requirements from multiple stakeholders and translating them into clear, fit-for-purpose analytical solutions.

• Awareness of regulatory and compliance requirements, with the ability to apply SOPs, validation practices and quality control principles to daily activities.

• Excellent analytical, communication, stakeholder engagement and problem-solving skills, with the ability to work independently and collaboratively.