AVP, Biostatistics - Smith Hanley Associates : Job Details

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Smith Hanley Associates trueAVP, Biostatistics

Remote , Lilly Corporate Center US

Posted: 07/31/2025 2025-07-31 2025-09-01 Category: Biostatistics Job Number: 23727Job Description

AVP Biostatistics, Group Head- ImmunologyRemote/Permanent

This is a senior leadership position responsible for guiding statistical strategy and execution within late stageImmunology programs. This role involves providing strategic statistical decision-making, overseeing novel clinical trial designs, and leading a team of statisticians.

Responsibilities:

• Implementing high-quality, scientifically sound statistical strategies for clinical development programs in Immunology.
• Managing a high-performing team of 20+ statisticians.
• Maintaining consistency in statistical methodology, study design, and analysis across various project teams.
• Overseeing the development of statistical analysis plans (SAPs) and contributing to protocol design.
• Ensuring the appropriate statistical methods and data integrity are applied for analysis.
• Effectively communicating complex statistical concepts and findings to non-statisticians.
• Collaborating with cross-functional teams, including physicians, clinical research scientists, regulatory affairs, and data management.
• Representing the statistics department at internal governance meetings, health authority interactions, and scientific conferences.
• Supporting regulatory submissions and responding to queries from health authorities.
• Driving the exploration and application of novel statistical methodologies and tools.
• Staying up-to-date with industry trends and advancements in statistical methodology.

Skills and Experience:

• PhD or Master's degree in Statistics or Biostatistics.
• 15-20+ years of experience in the pharmaceutical/biotech industry required.
• In-depth knowledge of statistical methods, experimental design, and data analysis in clinical development.
• Proven ability to lead and develop high-performing teams.
• Excellent written and oral communication, including presenting complex information to various audiences.
• Demonstrated ability to work effectively with cross-functional teams and senior leadership.
• Understanding of regulatory requirements related to clinical studies and submissions.
• Experience with statistical programming languages such as SAS, R, and Python.

Meet Your RecruiterNihar ParikhExecutive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley 's stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing.

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