Are you passionate about quality and simplification? do you want to build quality within processes in the most efficient way? do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? if so, there is a job opportunity waiting for you as our new associate statistical monitorAt novo nordisk, we will challenge you to do the best work of your life.
The position:
The associate statistical monitor is responsible for operating and maintaining the centralised statistical monitoring function in global development.
The statistical monitoring function is one element of the novo nordisk compliance with risk based monitoring.
The statistical monitoring function is responsible for identifying clinical data patterns which could indicate irregularities, non-compliance with protocol specifications, or fraud not otherwise capturedFindings which may impact the data quality of the registration package for a new drug application and thus the approvability of new drug candidates.
The associate statistical monitor is responsible for communicating irregularities to relevant stakeholders including management.
Key responsibilities/main job tasks:
Responsible for operating and maintaining the statistical monitoring function for the detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials and projects in global development.
Responsible for communicating findings to trial teams/project teams and management and contribute to the prevention of the occurrence of low quality or erroneous data and the correction of such data.
Contribute in developing the competencies of structured statistical monitoring.
Responsible for knowledge sharing, skill building and good collaboration with stakeholders and colleagues.
Qualifications:
Education:
Holds university degree in life science or engineering (e.gB.sc., msc, md) or equivalent.
Experience:
0-2 years of experience in pharmaceutical industry and preferably 1 year of experience with exploration and/ or visualisation of clinical trial data and scientific data.
Experience from clinical development and understanding of data flow.
Thorough understanding of clinical research and gcp.
Understanding of basic statistical methods, preferably experience from reporting/publishing clinical/scientific data.
Good knowledge on computer systems and it.
Exposure with sas jmp programming.
Worked according to gxp and guidelines within drug development.
Personal skills:
Independent drive and ability to get tasks done within agreed deadlines
Quality mind-set and strong analytical skills
Preference for working independently with statistical monitoring and it tools
Team oriented personality with high degree of flexibility and cross-cultural awareness
Good presentation, communication and collaboration skills
Training and mentoring of the new team members
Ability and willingness to adjust quickly to new situations in a continuously developing environment
Act as ambassador for nn way.
About the department
Clinical data science, global business services (cds gbs) was started in september 2007 and within a short span of eight years since its inception, has transitioned from a small start-up to one of the largest units in gbs and a key contributor to novo nordisk clinical development portfolioAs the organisation is growing along with the research & development portfolio, we are looking for several new medical reviewing colleaguesIn clinical data science, we are responsible for managing clinical drug development worldwide from early development phases to product introductionThe cmu support is established in gbs to support the risk based monitoring of clinical trials conducted by novo nordisk in line with health authority requirementsThe unit is responsible for performance of centralised medical review of patient data that includes medical monitoring and lab surveillance; and generation of visualisations and reports identifying outliers and trends from various data sources.
Working at novo nordisk
At novo nordisk, we don’t wait for changeWe drive itWe’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 futureWe embrace the spirit of
Experimentation, striving for excellence without fixating on perfectionWe never shy away from opportunities to develop, we
Seize themFrom research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
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.
For further information, please visit career site of novo nordisk.
Deadline
Apply before june 30,2022.
Millions rely on us
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 worldWe 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 culturesWe are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate inTogether, we’re life changing.
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