Systems Analyst II

• Competitive compensation + shift allowances

• Attractive benefits (security, flexibility, support and well-being)

• Engaging employee programs

• Technology for hybrid working and great onsite facilities

What youll be doing

• Create, maintain and test code used for non-standard data file creation as well as for CDISC SDTM and ADaM datasets; mentor System Analyst I staff; programming resource for Clinical Data Operations staff and other departments as needed including creation of statistical and submission-ready datasets.

• Attend client meetings as appropriate to understand data collection requirements for the protocol.

• Receive and review standard Clario/non-Clario standard client file specifications from Data Manager/Project Manager or client and interact with the client to finalize transfer specifications.

• Develop and validate programs to create non-standard data files as well as CDISC SDTM and ADaM compliant datasets.

• Create submission-ready datasets for cardiac safety trials (SDTM EG and ADaM ADEG) including define.xml and dataset reviewers guides for FDA submissions.

• As part of the Software Development Life Cycle, develop and unit test code, create and execute test scripts and perform peer review.

• Process data extracts, review encoding requests daily to run encoding programs and archive studies.

Performing ad-hoc programming activities utilizing raw data based on internal and external requests for:

• Esoteric quality control checks.

• Data resolution/mining.

• Treatment emergent flags and other specifications per Statistical Analysis Plan.

• Other client requirements.

• Work with data management in providing programming support for DM activities including data review.

• Prepare and participate in internal and external audits.

• Work across multiple service lines and modalities.

• Work hand in hand with a cross functional teams (Cardiologists, Data Managers, Project Managers and other industry experts) for project delivery - for example to support New Product Initiatives and Minimum Viable Product solutions.

• Identify opportunities to improve the methodology and provide practical solutions for problems.

• Contribute to the development of best practice to improve quality, efficiency and effectiveness.

• Assist with orientation and training of CDP and Data Management / Project Management personnel as determined by management.

• Mentoring System Analyst I and other CDP resource.

• Contribute to process development.

• Review and development of SOPs and associated documents related to CDP activities. Maintain working knowledge of CDISC SDTM/ADaM standards and recommend changes to processes and standard specifications as needed.

• Complete administration tasks as needed within CDP.

What we look for

• SAS Certified Specialist: Base Programming.

• SAS Certified Professional: Advanced Programming is a plus.

• Bachelor s or Masters degree in Informatics, Mathematics, Computer Science or other relevant qualification.

• Ideally three or more years of experience in a Pharmaceutical company or a CRO as a SAS Programmer - experience in SAS/BASE, SAS/MACRO and SAS/SQL products and procedures and one or more years experience in database design and data structures.

• Understanding of the pharmaceutical drug development process, as gained through a minimum of two years experience in the pharmaceutical or healthcare industry.

• Proven experience working with large, complex, real-world data sets (more specifically patient data).

• Extensive experience in implementing CDISC SDTM and Define standards. Working knowledge of EG, CO, RE and QS CDISC domains would be valuable.

• Knowledge of technical and regulatory requirements related to the role.

• Excellent time management skills, contributing to multiple projects with competing timelines.

• Strong written and verbal communication skills Fluency in English (spoken and written).

• Assist in developing and delivering training.

• Experience with Windows and Microsoft Office products.

• Experience with DB programming is a plus.