Serve as the indication expert biostatistician and lead all statistical activities of a major indication (across assets)
Drive novel approaches and optimize the process across all stages of clinical development in the indication you are responsible for
Drive quantitative data strategy of the indication you are responsible for
Collaborate with stakeholders and lead delivery of all statistical deliverables
Oversee delivery of all statistical deliverables for the indication you are responsible for and contribute to HA submissions
Report to a franchise team leader, within the Biostatistics and Modeling organization
Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
Guide the team of statisticians supporting the different assets

Master or doctorate (Ph.D.) degree in Statistics or related field
At least 7 years of experience in biotech/pharma industry
Proven record of leading statistical activities, including dossier submission and major agency interactions involving BLA/NDA/MAA (pre and post dossier submission)
Expertise in drug development
Experience driving complex innovative designs or cutting-edge methods
Advanced knowledge of biostatistics and a strong command of its application to clinical trials
Proficient in statistical software (SAS and/or R)
Ability to collaborate with program partners and stakeholders to deliver on the statistical deliverables
Ability to clearly explain complex statistical concepts in written and spoken English
Team player with a focused attitude
Ability to work autonomously as part of a cross-disciplinary team in a dynamic environment of a fast-growing biotech company with challenging timelines
Ability to motivate and empower statisticians supporting you

Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies
A work-environment in a human-sized, dynamic, rapidly growing biotech company
Competitive salary with extensive benefits
Chance to grow and be a part of a team driven by creativity, innovation and science
Eligibility to participate in short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies
Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines

Biostatistics Director – Indication Lead, Myasthenia Gravis

Key skills