Merck Senior Clinical Data Programmer Role For Life Sciences, Apply Online

Senior Clinical Data Programmer

Job Id: 278859

Bangalore, Karnataka, India

Job Type: Full-time

Your Role:

A. Trial activities:

Clinical Data Programming

• Develop, validate, document, and maintain program(s) and applications required to conduct or support clinical data quality checking and surveillance for clinical trials and/or programs (e.g., DQSP, CQR, coding checks, SQSP, SDTM checker, SAE/external data reconciliation, required reports, listings or figures with SAS, R, or other programming languages).
• Create, validate, document, and maintain data conversion programs, following company-level standards.
• Run (the developed) tools, programs, and macros according to timelines communicated by the ordering client/role.
• Handle adhoc programming requests (e.g., data format transfer and data pooling per request).

Operational Data Programming

• Provide technical solutions to centralized monitoring activities, develop, validate, and maintain the programs to identify the risk signals (e.g., key risk indicators (KRIs) for clinical data and key quality indicators (KQIs) for operational data).
• Develop, validate, and maintain the operational data reports (e.g., clean patient tracker (CPT), key quality indicator (KQI)).

Other

• Communicate status and results to task owners in a timely manner.
• Provide relevant documentation and data for archiving.
• Provide programming support for strategic initiatives as assigned.

B. Non-trial activities:

• System maintenance/enhancements.
• Contribute to the continuous improvement, re-engineering, and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working Instructions (WIs) as needed.
• Contribute as a team member to DMMI initiatives.
• Create and maintain globally re-usable SAS programs/macros that streamline repetitive operations for clinical studies.
• Program administrative reports as needed for clinical trials.
• Communicate technical programming concepts in a clear, concise, and focused manner.
• Develop experience and skills in new systems when necessary.
• Provide training and guidance to Clinical Data staff on the use of the applications (existing and new ones).
• Keep up to date with job-related topics, particularly with regard to SAS, R, Spotfire, and other potential languages and applications.
• Stay current with SOPs, WIs, and user manuals, and maintain a training log.

Senior Specialist, Program & Application Development

• Work effectively in a mixed environment and use best practices and knowledge or even interpretation of internal and external business issues to improve products or services and to define processes and standards.
• Solve high complexity problems based on advanced to sophisticated analytical skills and complex judgment.
• Be accountable for the quality of ongoing activities/processes. Receive minimal guidance or work independently.
• Act as an advisor within the team regarding processes and technical solutions.

Job Specific Competencies & Skills

• Comprehensive knowledge of SAS/BASE, SAS/Macro, and R. Knowledge of SQL, Python, or other programming languages is a plus.
• Good knowledge of EDC (e.g., Inform, Medidata Rave, Oracle RDC).
• Comprehensive knowledge of CDISC in general and comprehension of SDTM and define.xml.
• Good knowledge of regulations and guidance regarding clinical development, the systems used in this context, and data management related aspects of e-submissions.
• Good team player who works effectively in international teams and multi-disciplinary groups.
• Excellent accuracy and attention to detail.
• Experience in leading low to moderate complexity projects with limited support from the supervisor.

Departmental Core Competencies:

• Adaptability/Flexibility, Critical Thinking, Strong Communication Skills, Accuracy/Quality of Work, Analytical Skills, Business Partnering, Problem Solving, Project Management, and Technology Skills and Knowledge.
• (Individual proficiency level is depending on the role/role-level)

Who you are:

• Advanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals), Mathematics, Computer Sciences, or equivalent industry experience in SAS, R, SQL, QLIK.
• Proven experience (5+ years) in the area of Clinical Data Management (e.g., as Clinical Data Manager, Clinical Data Management Programmer, within Centralized Monitoring, or as a Data Analyst in the pharmaceutical/biotechnology industry).

Link to apply: Apply Here

Keywords: Senior Clinical Data Programmer, Job Posting, Clinical Data Programming, SAS, R, Clinical Data Management, EDC, CDISC, Bangalore. Merck Clinical Data Programmer Role For Life Sciences, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.