Vice President, Biostatistics

GENERAL SUMMARY

The incumbent provides enterprise-level strategic statistical leadership and oversight across assigned programs and the Biostatistics function; drives collaboration, quantitative decision making, and development strategy; oversees CRO performance; develops and mentors statisticians and people leaders; and acts as Head of Biostatistics when needed.

MAJOR DUTIES & RESPONSIBILITIES:

• Provides executive-level leadership and accountability for global development program strategy, including design, analysis, interpretation and reporting, health authority response, publication strategy, and quantitative decision making.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and support robust drug development plans.
• Provides strategic oversight and guidance to staff and CROs to complete high-quality study deliverables on schedule and to quality standards.
• Leads or sponsors development and review of policies, SOPs and controlled documents for process improvement, inspection readiness, and operational efficiency.
• Provides strategic statistical input in regulatory documents and scientific articles.
• Leads data generation strategy for podium presentations and payor discussions.
• Contributes to team development, succession planning, departmental and functional strategy.
• Keeps abreast of, contributes to, and represents the organization on scientific advances in the field.
• Performs other duties as assigned.

QUALIFICATIONS:

Education:

• PhD in Statistics, biostatistics or related fields or Masters with significant experience

Experience:

• 14+ years of pharmaceutical industry experience with a PhD, or 15+ years with an MS.
• Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
• 10+ years of management experience, including leadership of senior technical talent and people managers

Other Qualifications/Skills:

• Hands-on familiarity with common and advanced statistical methodology.
• Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery.
• Knowledge/experience of global regulatory requirements in novel endpoints and rare diseases is a plus

Travel:

<5%

Physical Requirements and Working Conditions:

• Physical activity includes repetitive wrist, hand, and finger motions; fingering; and talking.
• Sedentary work involving sitting most of the time, with occasional walking and standing and exerting up to 10 pounds of force occasionally or negligible force frequently or constantly.
• The worker is not substantially exposed to adverse environmental conditions, as in typical office or administrative work.