Senior Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic statistical guidance and oversee all statistical facets of biosimilar development for various products.

• Lead, manage, and nurture the biosimilars biostatistics team.

• Supervise the performance of biostatisticians within Contract Research Organizations (CROs).

• Enhance the understanding of statistics within Biosimilar Development.

• Innovate methodologies and study designs tailored for biosimilars.

• Support the head of Biostatistics and Statistical Programming in departmental leadership.

• Oversee protocols, Statistical Analysis Plans, Flash Memos/Summary of Reports, Clinical Study Reports, submission documents, health authority communications, clinical publications, reimbursement documents, and additional correspondence.

• Contribute strategic statistical insights to clinical development plans.

• Ensure adherence to standards, technical quality, and consistent practices in clinical development strategies, study design, statistical analysis, data structures, and presentation of results.

• Provide statistical insights into regulatory strategies, presentations, scientific reports, clinical trial submissions, product defense, market support, and scientific publications.

• Represent Biosimilar Development on statistical issues to regulatory agencies, key opinion leaders, and expert organizations.

• Offer oversight and direction to Amgen and CRO personnel regarding study deliverables, timelines, and quality benchmarks.

• Recruit, allocate, manage, and develop in-house statistical staff; contribute to the establishment of goals, budgets, and resource plans.

• Lead or engage in the development and review of Policies, SOPs, and controlled documents.

• Advocate for and communicate statistical methodologies; publish applied research and present findings at external scientific conferences.

• Foster relationships with academic, regulatory, and industry statistical thought leaders.

⛳️ Requirements

• Doctorate degree with 5 years of experience as a Senior Director in Biostatistics; OR a Master’s degree with 9 years of experience in the same role; OR a Bachelor’s degree with 11 years of experience as a Senior Director in Biostatistics.

• Minimum of 5 years of direct people management experience and/or leadership experience in leading teams, projects, programs, or directing resource allocation.

• Proven track record of strong leadership and people management capabilities.

• Statistical leadership experience for regulatory submissions, including advisory committees.

• Demonstrated proficiency in written and verbal communication skills, especially in statistical strategy.

• Doctorate in Statistics/Biostatistics with at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research, or a Master’s degree in Statistics/Biostatistics with at least 10 years of post-graduate statistical experience in the same fields.

• Ten years of post-graduate statistical experience within the pharmaceutical industry.

• Capability to collaborate within a global team and with CRO partners.

• Experience in life-cycle drug development encompassing pre-clinical development, clinical development, and post-marketing activities.

• Knowledge and experience in biosimilars development, including global regulatory requirements and the design and analysis of non-inferiority and equivalence trials.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Competitive salary and performance-based bonuses.

• Flexible work arrangements and a supportive work environment.