Seeking a Systems Analyst (internally referred to as SAS Programmer) to 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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.
OTHER DUTIES AND RESPONSIBILITIES:
- 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.
QUALIFICATIONS AND SKILLS NEEDED:
- SAS Certified Specialist: Base Programming.
- SAS Certified Professional: Advanced Programming is a plus.
Education:
- Bachelor s or Master s degree in Informatics, Mathematics, Computer Science or other relevant qualification.
Experience:
- 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.
