Senior SDTM Programmer

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

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.

• 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 about but not limited to Protocol, Flow chart, electronic CRFs (eCRF), External Specifications, and SDTM Domains.
• Prepare & review metadata specification (as relevant) and CRF. 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's 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 of 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.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees worldwide. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life-changing.

Contact

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline

19th May 2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.