Job title: SDTM Programmer in Global Development //
Company: Novo Nordisk //
Job description: Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? Then we might have the right position for you
Your key responsibilities in the job is to design and set-up of study database for clinical trials on different sources, Mapping of metadata and clinical data from source system(s) to CDW (Clinical Data Warehouse) 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, and create trial in CDMS (Clinical Data Management System), set up trial database and activate the database in OC (Oracle Clinical) upon approval from relevant stakeholders, Perform and document UAT (User Acceptance testing) for checking the quality of OC database and 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.
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 Standards Specialist.
The below knowledge, skills and experience will be required for the position.
- M.Sc. / B.Sc. in Life Science or comparable degree in Computer Science, Information Technology clinical information management or equivalent qualifications
- At least 2-3 years of experience working as a statistical programmer within the pharmaceutical industry
- Extensive experience with SAS programming
- Extensive experience with reporting clinical trials, including statistical data handling, analysis and reporting
- Extensive experience with validation and documentation of programs
- In-depth knowledge of drug development
- Experience with clinical database technologies, data models and advanced programming
- Experience with collaboration across professional and regional borders
- Regular experience with communication and presentations
- In-depth 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
Clinical Data & Systems Support, Global Development 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, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference.
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Manager before applying.
Deadline * 15 Apr 2021
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development. //
Expected salary: //
Location: Bangalore, Karnataka //
Job date: Sat, 19 Dec 2020 03:11:34 GMT //