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Novo Nordisk
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Statistical Monitor

Statistical Monitor

Novo Nordisk

2 - 5 years

5 - 8 Lacs

Bengaluru

Posted:20 hours ago| Platform:

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Skills Required

exploration jmp clinical research gcp data visualization pharmaceutical sas business services reliability clinical data management data integrity clinical data sql portfolio quality improvement clinical development clinical trials doe

Work Mode

Work from Office

Job Type

Full Time

Job Description

Novo Nordisk Global Business Services (GBS) India
Department- Clinical Drug Development (CDD) - Bangalore Global Development
Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position as Statistical Monitor for you. Apply now and join a growing team, working in an international environment. About the department
Clinical Data Science, Global Business Services (CDS GBS) was started in September 2007 and within a short span of 16 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 portfolio. As the organisation is growing along with the Research & Development portfolio, we are looking for several new medical Reviewing colleagues. In Clinical Data Science, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. The CMU Bangalore is established in GBS to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is responsible for performance of centralised medical review of patient data that includes medical monitoring and lab surveillance; Statistical Monitoring analysis, and generation of visualisations and reports identifying outliers and trends from various data sources. The Position
The Statistical Monitor plays a critical role in supporting Risk-Based Monitoring within Clinical Drug Development by operating and maintaining the centralized Statistical Monitoring function. This position focuses on detecting unusual data patterns, systematic errors, and potential instances of non-compliance or fraud that may not be identified through routine monitoring processes. The Statistical Monitor analyses clinical data across trials and projects to safeguard data integrity, which is essential for the approval of new drug. The role requires a high level of independence, with the potential to mentor junior colleagues and contribute to continuous improvement in data reliability and compliance.

Responsible to operate and maintain the Statistical Monitoring function to identify unusual data patterns, systematic errors, and potential protocol non-compliance or fraud across clinical trials and projects.

Work closely with trial and project teams, as well as data management and programming experts, to plan and execute statistical monitoring activities according to project timelines.

Communicate monitoring observations to relevant stakeholders, support the interpretation of data issues, and contribute to data correction and quality improvement efforts.

Contribute to the development, maintenance, and enhancement of statistical monitoring tools and methodologies, including exploring and implementing new techniques.

Support training initiatives, participate in meetings and seminars, and foster strong collaboration and knowledge sharing with colleagues and cross-functional teams.

Qualifications

Holds university degree in life science or engineering (e.g. B.Sc., MSc, MD) or equivalent.

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.

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Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

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Statistical Monitor