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Modelling Specialist

5 months ago

bangalore, India Novo Nordisk AS Full time

Department - Pharmacometrics

Are you an expert in pharmacometrics methods? Do you have extensive experience in drug development and clinical trials? We are looking for a skilled Pharmacometrician to join our team and contribute to the success of our clinical development projects. If you are passionate about using mathematical and statistical models to analyze data and make predictions about drug behavior, efficacy, and safety, then this role is for you. Apply today and embark on a life-changing career with Novo Nordisk.

About the department

In Pharmacometrics we are approximately 30 modeling scientists organized in two departments and supporting the entire Novo Nordisk development portfolio (e.g. Diabetes, Obesity, rare blood disorders, and other serious chronic diseases), with model-based analyses. We are involved in the planning and execution of first-in-human trials to registration and beyond. As we support all drugs in clinical development, across phases, we perform a wide variety of modeling tasks. We see our Pharmacometrics department as a strong scientific community that faces many interesting and challenging tasks in the drug development process. We have many international employees, and we welcome non-local applicants. We maintain a positive and collaborative atmosphere in our everyday work and ensure a healthy work-life balance.

The Position

As Modelling Specialist, you will be part of multidisciplinary project teams where you will be responsible for PK/PD modelling plans and analyses across projects. You will play an important role in the development of new drugs at Novo Nordisk as the responsible person for designing, analyzing, interpreting, communicating, and reporting pharmacometrics information at all stages of clinical drug development. This includes modelling PK data from ongoing clinical programs, performing exposure-response analysis of efficacy and safety data, performing clinical trial simulations of new trials to be initiated, and presenting and guiding the project team on your results.

As a Modelling Specialist at Novo Nordisk, you will have the following responsibilities:

Drive the pharmacometrics strategy of designated projects, considering the impact across Development. Plan the development of drugs, design clinical trials, and interpret the results of the trials. Shape and drive the pharmacometrics content and quality of deliverables for submissions and authority interactions. Identify opportunities for new methodologies and processes to save costs, and time, and increase quality. Performing clinical trial simulations to inform the design of new trials and optimize study parameters. Presenting findings and providing guidance to project teams on the implications of the results for drug development strategies.

Qualifications

 To be successful in this role, we are looking for a candidate with the following qualifications:

Academic qualification in pharmacometrics at the level of PhD or equivalent.  Proficient/skillful in pharmacokinetics/pharmacodynamics (PKPD) theory and modelling, statistical methodology, and data interpretation. Minimum 7 plus years of experience as a pharmacometrician within the pharmaceutical industry or equivalent. Strong experience with pharmacometrics software and IT and in-depth experience with at least one pharmacometrics software package, such as R and NONMEM. Knowledge specialist in drug development. Extensive experience with communication and presentation of pharmacometrics issues. In-depth knowledge of GCP and pharmacometrics guidelines within drug development. Experience with health authority interactions and submissions. Understanding of FDA, EMA, and other regulatory guidelines related to drug development. Regular participation in medical and statistical conferences/workshops. Excellent Communication and Stakeholder Management skills.

Working At Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 64,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.