argenx
United in our commitment to improve the lives of patients
Biostatistics Director – Indication Lead, Myasthenia Gravis
Location
Massachusetts
Posted
23 days ago
Salary
Not specified
Postgraduate Degree7 yrs expEnglish
Job Description
• 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
Job Requirements
- 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
Benefits
- 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
