Principal Biostatistician FSP - Late Phase

Principal Biostatistician FSP – Late Phase

PhD in Statistics, Biostatistics, or related field with 5+ years industry experience
MS in Statistics, Biostatistics, or related field with 7+ years of industry experience
At least 3 years in Phase 2/3 clinical trial experience
Demonstrated ability to work pro-actively and independently
Able to effectively communicate his/her ideas and to manage programmers in a constructive manner
Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards
Experience with CDISC, including SDTM, ADAM, CDASH

Collaborate with multi-disciplinary project teams to establish project objectives and timelines
Write the statistical sections of clinical trial protocols, while consulting with internal and external experts
Author statistical analysis plans
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources
Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise
Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures
Interpret study results and review reports of study results for accuracy
Support exploratory analyses
Participate in pre-IND or NDA activities
Participates in other activities and meetings to support Biostatistics and the Development Team as needed