Director, Safety and Monitoring Biostatistics

CSL - King of Prussia, PA

Full-time - Senior

Hybrid - King of Prussia, PA

10,001+ employees

Ambulatory Health Care Services

About the position

The Director of Safety and Monitoring Biostatistics at CSL Behring is a senior leadership role responsible for overseeing statistical strategies and methodologies used in clinical development programs. This position ensures the application of modern statistical monitoring methods to address safety and quality concerns throughout the clinical development lifecycle. The role involves managing a team of statisticians, collaborating with various stakeholders, and representing Biostatistics in regulatory interactions.

Responsibilities

• Manage a team of statisticians in one or more therapeutic areas.
• Provide statistical strategies for clinical development programs and regulatory submissions, ensuring accountability for statistical deliverables.
• Lead the full scope of Biostatistics contributions to responsible areas.
• Coordinate with partners through the Stage Gate process.
• Partner with TA Head and other functional leads within the areas.
• Influence and contribute to clinical development plans (CDPs/TPPs).
• Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
• Ensure sound statistical foundation underpinning program strategy within the responsible area.
• Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions.
• Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA.
• Provide statistical leadership dealing with concepts and complexity.
• Work with senior management and external KOL.
• Manage the Biostatistics team to achieve corporate and department goals.
• Provide technical statistical expertise, leadership, and mentorship to staff.
• Mentor staff and cultivate professional growth.

Requirements

• MS in Biostatistics, Statistics, or related fields.
• 10+ years in Clinical Development in a Pharmaceutical or Biotechnology setting.
• Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy.
• Experience in interactions with major regulatory authorities and regulatory submissions.
• Demonstrated statistical expertise in facilitating clinical development strategy.
• Expertise in CDISC, statistical programming, and/or data standards and Biostatistics and Statistical Programming Operations.

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Paid time off
• Vision insurance
• Life insurance