Senior Manager, Biostatistics

The Senior Manager, Biostatistics - Neuroscience will be expected to work independently with minimal supervision, serving as study statistician for clinical studies. The study statistician will be accountable for supporting protocol development and study initiation, developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter, providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation, supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The immediate need is to support Phase II and III studies within the Neurology Business Group. PhD strongly preferred, but combination of education and experience may be considered in lieu of PhD Experience in clinical development biostatistics methods and processes in industry setting required Functional Technical Competency in the following: Clinical Development Plan Creation Statistical Analysis Statistical Programming Regulatory Process for Biostatistics Business Knowledge Therapeutic Area Knowledge Regulatory Knowledge Project and Resource Management Compliance we do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732-844-8724 | LinkedIn: Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.