Job Description

Senior Principal, Biostatistician

(AD/Sr. Manager, Biostats)

As a Senior Principal, Biostatistician , you will serve as the biostatistical lead in clinical study design for pivotal trials, overseeing activities to ensure the proper design, analysis, and presentation of clinical studies.

How You Will Make an Impact:

• Act as a core team member/lead biostatistician for assigned clinical trials in the US and international/global settings.
• Accountable for clinical trials assigned to direct reports.
• Manage and oversee a small biostatistics team and may indirectly manage cross-functional or matrix teams as appropriate.
• Provide technical/statistical leadership for multiple and/or complex clinical projects in collaboration with cross-functional teams.
• Develop a robust talent development plan aligned with departmental growth strategies.
• Develop and implement biostatistics strategies, including negotiations with internal and external parties.
• Provide guidance on process improvement projects within biostatistics and cross-functional areas.
• Create, maintain, and implement SOPs, processes, standards, and work instructions to ensure compliance and optimization.
• Manage activities ensuring the successful completion of all deliverables, identifying risks, and developing mitigation strategies in collaboration with teams.
• Provide statistical expertise to internal and external stakeholders (e.g., presentations, publications).
• Make resource planning and budgetary recommendations on operational expenditures.

What You'll Need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or a related field with analytical experience in clinical trials, or
• Master’s Degree or equivalent in Statistics, Biostatistics, or a related field with relevant analytical experience.
• Experience in clinical trial design and FDA/EMEA/PMDA submission experience.
• This position can be remote within the United States.

What Else We Look For (Preferred):

• Expert understanding of clinical trial design and methodologies to resolve complex problems.
• Demonstrated ability to manage a team, providing coaching and feedback, including responsibility for employee actions.
• Dedicated to quality client service and responsive to client needs.
• Ability to interact professionally with all organizational levels and escalate issues appropriately.
• Ability to thrive in a fast-paced, dynamic environment.
• Proficiency in statistical programming languages such as SAS and/or R.
• Strict attention to detail and proven project management leadership skills.
• Excellent written and verbal communication skills, including negotiating and relationship management.
• Promote a culture of collaboration and teamwork.
• Adhere to all company rules and requirements (e.g., safety protocols).

For California, the base pay range for this position is $190,000 to $210,000 (highly experienced).

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