Sdtm Programmer

2 weeks ago

Bengaluru Karnataka, India Novo Nordisk Full time

SDTM Programmer

**Category**:Data & AI**Location**:Bangalore, Karnataka, IN**Department: SDTM Programming & Submission**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 is 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 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.- 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 to the Novo Nordisk SDTM Implementation Guide (NN SDTMIG).
- Responsible for reviewing and providing inputs to data collection requirements in relation but not limited to Protocol, Flow chart, electronic CRFs (eCRF), External Specifications, 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 Lead SDTM Programmer.

**Qualifications**- Bachelor's or Masters in life sciences, natural sciences, pharmacy, veterinary science, engineering, clinical information management, computer science or equivalent qualifications.
- Minimum 2 -5 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 around the world. 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**-
**Deadline**
- 17th April 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.

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