4DMT is seeking to advance durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The incumbent will provide strategic statistical input and oversee all statistical aspects of assigned programs, driving cross-functional collaboration and decision making for program(s), overseeing CRO performance, and mentoring other statisticians.
Requirements
- Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
- 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
Responsibilities
- Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) in the global development program
- Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
- Provides 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 participates in the development and review of Policies, SOPs and other controlled documents for process improvement and operational efficiency.
- Provide statistical and strategical input in regulatory documents and scientific articles.
- Lead data generation team for podium presentations and payor discussions.
- Plays a critical role in shaping team development and contributing to departmental strategy.
Other
- PhD in Statistics, biostatistics or related fields or Masters with significant experience
- 12+ years of pharmaceutical industry experience with a PhD, or 14+ years with an MS.
- 8+ years of management experience
- Travel: <5%
- 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).
