Bioclinica
Location
Bangalore | India
Job description
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
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 Master s 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.
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