Statistical Monitor

2 - 7 years

5 - 8 Lacs

Posted:None| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
Novo Nordisk logo
Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

RecommendedJobs for You