(Senior) Principal Biostatistician (m/f/d)

Division Global Drug Development
Geschäftseinheit CD&A GDD
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 269361BR


Stellenbeschreibung

8 biosimilars are already approved and more than the same number are in development (analytical and clinical research). You contribute to filling and maintaining the portfolio through close collaboration with our Clinical Development Team and other departments.

Your responsibilities:

• Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required.
• Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
• Initiate, drive and implement novel methods and innovative trial designs as or in alignment with the Lead Statistician.
• Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
• Represent Biosimilar Biostatistics in statistical discussions at external congresses, conferences, scientific meetings.
• Responsible for functional alignment and ensuring line function awareness throughout the assigned trials.
• Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
• Contribute to the statistical scientific content of materials for internal decision boards/regulatory/submission documents: Briefing Books, decision criteria, trial design(s), responses to trial-specific Health Authority questions.

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Research & Development


Mindestanforderungen

What you’ll bring to the role:

• MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience
• Experience in all tasks of a statistician at the trial level and independence in the role and proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts
• Proficiency in use of statistical software packages (e.g. SAS, R)
• Good knowledge of drug development and Health Authority guidelines
• Ability in effectively working on a multidisciplinary team to achieve team objectives
• Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions
• Fluent English (oral and written), German of advantage

Desirable Requirements:

• Good team player. Good business ethics
• Good communication and presentation skills

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine.

Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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