Principal Biostatistican

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The Principal Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision.
Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic.
• Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate.
• Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner.
• Provide coordination between the project resources so that deadlines are met on deliverables.
• Drive development of appropriate user training.
•  Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

What you’ll bring to the role:

Essential Requirements:

• Education (desirable):

  MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)

  Languages:

  Fluent English (oral and written)

  Good communication and presentation skills.

  Experience/Professional

  Requirement:

• Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
• Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
• Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

 Languages:

• English.

Skills Desired

Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis