Principal Biostatistician FSP, Phase 1 to 3 Safety

The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. This includes writing statistical sections of clinical trial protocols, authoring statistical analysis plans, and monitoring internal and CRO project activities.RequirementsPhD in Statistics, Biostatistics, or related field with 5+ years industry experienceMS in Statistics, Biostatistics, or related field with 7+ years of industry experienceAt least 3 years in Phase 2/3 clinical trial experienceDemonstrated ability to work pro-actively and independentlyAble to effectively communicate his/her ideas and to manage programmers in a constructive mannerAbility to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessaryUnderstanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standardsExperience with CDISC, including SDTM, ADAM, CDASHBenefitsHome-based remote working opportunitiesWork/life balance as well as flexible schedulesTechnical training and tailored development curriculumResearch opportunities that match your unique skillsetPromising career trajectoryJob stability: long-term engagements and re-deployment opportunitiesFocus on bringing new therapies to market rather than project budgets and change ordersExperience with regulatory submissionsOriginally posted on Himalayas