Senior SDTM Programmer

1 week ago

Bengaluru, Karnataka, India Novo Nordisk AS Full time

Department: SDTM Programming & Submission

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

About the department

Bangalore Global Development, Global Business Service (GBS), SDTM Programming & Submission team was established in April 2016 and became a separate department in July 2021. The team has a good blend of experience and fresh perspective and comprises experienced SDTM Subject Matter and Submission experts, who form the core of the team. The main purpose & objective are to ensure high-quality compliant submission-ready SDTM packages in close collaboration with our stakeholders across the clinical landscape, for all clinical trials within Novo Nordisk.

The Position

A Senior SDTM Programmer will be responsible for ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) and promote the exchange of knowledge within the organization and externally via participation in meetings/conferences. The Senior SDTM Programmer is recognized as responsible for supporting end users and must act independently, following the strategic objectives of the standards governance bodies and the company in general. The Senior SDTM Programmer will be responsible for assisting in solving methodological or technical demanding tasks where innovation is a key element.

Generate SDTM datasets and perform QC. Create and maintain Study Data Reviewer's Guide (SDRG). Prepare contents for the External Committee package based on trial requirements and engage with Safety Surveillance/external statisticians.

Responsible for finalizing Study Data Tabulation Model (SDTM) deliverables and to review of eCRFs, special attention should be given to non-standard modules, regarding the impact on SDTM. Perform custom programming as required and validate according to relevant SOP. Run Pinnacle 21 checks and resolve issues by coordinating with the Trial squad. Ensure compliance with the Novo Nordisk SDTM Implementation Guide (NN SDTMIG). Responsible for reviewing and providing inputs to data collection requirements in relation to but not limited to Protocol, Flow chart, electronic CRFs (eCRF), External Specifications, and SDTM Domains. Prepare & review metadata specification (as relevant) and aCRF. Submit requests to Standards Teams to either deviate from an existing standard or use a trial-specific element in alignment with the Lead SDTM Programmer.

Qualifications

Bachelor's or Master in life sciences, natural sciences, pharmacy, veterinary science, engineering, clinical information management, computer science or equivalent qualifications. Minimum 4-6 years of experience in the Life Sciences industry and preferably 4 years within Clinical Data Management and with hands-on experience in Clinical Data Interchange Standards Consortium (CDISC) SDTM. Excellent communication skills. Expert knowledge on end-to-end clinical data management activities. Experience with collaboration across regional borders. Experience with mentoring and presentations. Participation in conferences/workshops. Demonstrated experience with project management. Ability to work in a diverse multi-cultural environment. Good knowledge of GxP and other guidelines within drug development.

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