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Lead Programmer Analyst
- Programming and implementation of SAS macros and utilities to support clinical data projects and other DS&A applications as applicable
- Lead setup and maintenance of integrations in studies for data Import into and Export out of RAVE, LSH, SWAN, Matchpoint Coder.
- Lead the setup of processes and technical program packages/macros to facilitate receipt of data from internal and external data providers using the available technology platforms
- Coach and train study teams on integrations and platform implementations in context of study build, conduct and close out
- Manage integration business rules and interactions with internal and external business/technology partners
- Design and execute software build responsibilities within the established technical standards and governance
YOUR TASKS AND RESPONSIBILITIES:
- Collaborates with colleagues in technical implementation for the software macros, tools and integrations within TAM
- Participates in software tool evaluation activities with software vendors and IT partners in context of operational implementation
- Design and documentation of operational processes for adoption of new and updated integrations and technology aiming for process and technology connectivity across platforms
- Implements technical setup for data review toolkits within existing end to end business processes
- Plan and implement quality and reconciliation activities for integrations within studies
- Execute validation activities related to tool and program packages release. Includes writing user acceptance test scripts, validation plans and associated reports
- Collaborate with functional representatives to provide software related technical and process training
- Provide support to business partners for software related audits/inspections by internal and external teams
- Coach and mentor study teams on specific technical requirements post general availability of toolkit
WHO YOU ARE:
- Master’s/Bachelor’s degree in a natural science, Statistics, Computer Science or a related field
- 7-11 yrs of in-depth experience in programming on commonly used technology platforms for data acquisition, transformation and reporting (i.e., SAS, SpotFire) is required
- Knowledge and experience in programming languages such as C#, SQL, SAS, PL SQL is required
- Knowledge in clinical trial start up, conduct and close out activities and associated technical best practices
- Hands-on experience with the technology platforms & utilities for the management of pharmaceutical sponsor proprietary or industry clinical data is required
- Understanding of industry standards on integration technology such as web services and odm.xml is also required.
- Effective time management skills to ensure completion of assigned task within planned timelines is required
- Understanding of global regulatory requirements, rules and guidance associated with Source Data in Clinical Investigations including CFR part 11 is required
- Experience in project management tasks and managing multiple integrations and toolkits as assigned is desired
- Experience in comprehensive software validation activities using different methodologies (ie waterfall, agile etc), inspections, analyses, and other verification tasks performed at each stage of the software development life cycle is required
- Effective interaction and training of teams in the understanding and usage of standards and technology is desired
- Effective written and verbal communication in English and usage of Microsoft Office is also necessary.
*Candidates interested in Bangalore location can also apply
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Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
|Location:||India : Telangana : Hyderabad|