GENERAL SUMMARY

The incumbent provides enterprise-level strategic statistical leadership and oversight across all statistical aspects of assigned programs and the broader Biostatistics function; drives cross-functional collaboration, quantitative decision making, and development strategy for program(s); oversees the performance of Contract Research Organizations (CROs); 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 strategy (design, analysis/synthesis, interpretation and reporting, health authority response, publication strategy, and quantitative decision making) in the global development program
• Leads senior-level collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans
• Provides strategic oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.
• Leads and/or sponsors the development and review of Policies, SOPs and other controlled documents for process improvement, inspection readiness, and operational efficiency.
• Provides senior strategic statistical input in regulatory documents and scientific articles.
• Leads data generation strategy for podium presentations and payor discussions.
• Plays a critical role in shaping team development, succession planning, and contributing to departmental and functional strategy.
• Stays abreast of, contributes to, and represents the organization on scientific advances in the field.
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time 

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 - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $330,000 - 390,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.