Sdtm Programmer
1 week ago
Department:
SDTM Programming & Submission.
The Position
- Your key responsibilities in the job is to map the metadata and clinical data from source system(s) to CDW (Clinical Data Warehouse) or Database Management workbench (DMW) and finalize SDTM (Study Data Tabulation Model) deliverables and also review and provide inputs to EDC (Electronic Data Capture) requirements in relation but not limited to protocol, flow chart, SDTM domains etc., Design the metadata specification and aCRF requirements.
- Finalize SDTM (Study Data Tabulation Model) deliverables. Also prepare and submit the request to Control of Standards group to either deviate from an existing standard or use a trial specific element in alignment with Lead SDTM Programmer.
- You should always be technically updated and ensure that the newest knowledge is shared with relevant stakeholders including super users in Clinical & Data Science on SDTM standards, interface integrations.
- Maintain system related documentation and facilitate implementation of business processes introduced by the systems supported by Data Management Systems & Standards (DaMaSys) and finally share better practices on use of standards in alignment with Lead SDTM Programmer and Standard Developers.
Qualifications
- Masters/ Bachelors in Life Science or comparable degree in Computer Science, Information Technology clinical information management or equivalent qualifications.
- Minimum 2 plus years of experience in pharmaceutical industry within clinical data management and hands on experience in CDISC SDTM.
- Good experience on end to end clinical data management activities, clinical database technologies, data models and advanced programming.
- Extensive experience with reporting clinical trials, including statistical data handling, analysis, reporting, validation, documentation of programs and Submissions.
- Knowledge with analysis and design of business processes within the area of drug development.
- Experience with collaboration across professional and regional borders.
- Experience with project management, communication and presentations.
- Indepth knowledge of computer systems and IT.
- Good knowledge of GxP and guidelines within drug development.
- Lives up to NN values: accountable, ambitious, responsible, and engaged with stakeholders, open and honest and ready for change.
About the department
Data Standards & Outreach under Clinical & Data Science, 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.
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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