Clinical Programmer Principal

The Principal Clinical Programmer conducts and coordinates programming activities for multiple studies. As an advanced practitioner in data management programming provides technical advice and support for programming activities to data management team. May oversee the work product of other programmers ensuring high quality and timeliness.
Experience in Pharma/Biotech is essential.

Key Duties and Responsibilities:

• Excellent understanding of SQL programming concepts and ability to write complex SQL programming code.
• Ability to configure a study/project using an ETL tool and write complex SQL queries for report development.
• Ability to ingest data from various data sources and also integrate the data from external applications using the ETL tool.
• Very high understanding of the Phase IIV clinical trial process
• Experience working in the Clinical data management function.
• Thorough understanding of the DM related study activities like CRFs reconciliation Manual data reviews etc.
• Ability to understand the department level SOPs WIs
• Knowledge about GxP systems and regulatory framework of the clinical systems
• Required to handle the clinical studies in CDSM independently and with minimal supervision.
• Collaborate with the stakeholders in CDSM (data managers data review team recon team) during the study and provide necessary Clinical programming input and provide solutions
• Ability to keep track of the clinical study milestones and align them with timely delivery of the reports.
• Ability to understand/speak in a concise and clear manner in all the department/study team level meetings and explain the issue/concerns from the programming point of view.
• Ability to develop any programming guidelines/documents if necessary.
• Providing creative programming solutions based on the daytoday study and DM process challenges.
• Ability to devise methodical approaches to solve the problems and proactively identify the possible risks/problems.

Knowledge and Skills:

• High proficiency in Programming languages in CDMS like SAS/ETL and SQL Plus and good knowledge of data standards such as CDISC and SDTM
• High proficiency in Clinical Data Management procedures including good knowledge of Good Clinical Practices (GCP) 21 CFR part 11 and other regulatory requirements
• Strong organizational influencing presentation documentation and interpersonal skills as well as a teamoriented approach.
• Significant demonstrated experience with clinical programming clinical data management CRO industry and data reporting along with languages such as SAS and SQL.
• Proven ability to independently determine the most appropriate methods and procedures across Clinical Data Management projects
• Displays strong writing and verbal presentation skills ability to convey complex/technical information to a variety of audiences and build alignment around an issue

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Remote Work :

No