Clinical Data Programmer

1 week ago

Bengaluru, India Novo Nordisk Full time

**About the department**

Data Systems & Automation, Clinical & Data Science GBS (DSA, CDS GBS) is one of the most competent and diverse team of professionals who are mainly responsible for providing functional and system support to execute clinical trials across Product Development Plan portfolio. The team has strong understanding of Clinical Systems & interfaces with end-to-start mindset on standardisation of data-flow across systems, Electronic Case Report Form (ECRF) development using Central Designer and hands-on experience with Clinical Data Interchange Standards Consortium (CDISC) concepts annotated Case Report Form (aCRF), Study Data Tabulation Model (SDTM) mapping, SAS programming, Study Data Review Guideline (SDRG) etc., to aid CDISC submission which is a mandate from regulatory authorities.

**The position**
- Design, Programming and validate programs to check data accuracy and aid report generation.
- Design and set-up of study database for clinical trials on different sources, mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench) / CDW (Clinical Data Warehouse).
- Generate SDTM (Study Data Tabulation Model) Deliverables.
- Active participation in sharing better practices on use of standards in alignment with Lead Clinical Data Programmer and Process & Automation Specialist.
- Responsible for requirements related to Clinical Data Acquisition Standards Harmonization and Clinical Data Interchange Standards Consortium.

**Experience**
- M.Sc./B.Sc. in Life Science or comparable degree in computer science, information technology, clinical information management or equivalent.
- Minimum 3-5 years of experience in pharmaceutical industry and preferably 2 years within clinical data management.
- Good experience on end-to-end clinical data management activities.
- Good knowledge of clinical systems and preferable experience in programming languages (eg: SAS/SQL/R/Python, Jupyter etc).
- Requires basic knowledge on Artificial Intelligence & Machine language to be part of automation/innovation initiatives within and across the departments.
- Profound knowledge of GxP and guidelines within drug development.
- Fluency in written/spoken English and good presentation skills.
- Team oriented personality with a high degree of flexibility.
- Quality mind-set and strong analytical skills.

**Working At Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales
- we're all working to move the needle on patient care.

**Contact**

**Deadline**

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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