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.
• 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.