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Job #03444

About our client Our Client is an international CRO that provides full-service clinical trials management support for various therapeutic areas, such as Oncology, Cardiology, and Medical Devices. Their vision is to become the preferred CRO for life science companies across the world. Position Location Senior Biostatistician Southborough, MA Salary Highly competitive package, commensurate with experience Responsibilities 1) The Senior Biostatistician fills a critical role within the Biometrics Department analyzing and interpreting confidential data from a variety of sources 2) Under minimal supervision the Senior Biostatistician is capable of working on highly complex projects suggesting analyses, compiling reports, charts and tables and interpreting results based on established statistical methods, relying on prior experience and judgment 3) Timeliness, excellent communication and professionalism are essential as staff in this position directly interact with personnel from a variety of technical backgrounds 4) Participate in the design and review of - Clinical protocols and case report forms (CRFs) including preparation of Statistical Considerations sections, sample size calculations, interim looks and study design recommendations 5) The database, data collection guidelines, and computerized logic checks used to assist data management 6) Create analysis plans detailing the objectives, statistical considerations, study populations, efficacy parameters, statistical methods and prototype tables, figures, and listings 7) Generation and implementation of the quality review process in conjunction with data management, biometrics, and programming support 8) Implementation of analyzed plans, provide guidance and training to Biometrics staff on statistical procedures, methods and concepts 9) Write and review statistical reports; provide statistical expertise to the Medical -Writer for integrated clinical and statistical reports 10) Design and manage generation of randomization schedules 11) Provide statistical support, potentially serving as primary contact, to clients and internal project team members 12) Provide input on statistical management for all projects and departmental operations 13) Prepare and review FDA statistical responses and Provide independent FDA representation 14) Participate in the interviewing process for departmental candidates 15) Participate in revising Biometrics policies, guidelines and operations 16) May serve as back-up biostatistician on other projects Requirements 1) Ph.D. in Biostatistics or related discipline and 2 years of experience with at least 1 year in a CRO, or a Masters degree in Biostatistics or related discipline with a minimum of 4 years experience, at least 2 years in a CRO 2) Ph.D. in Biostatistics and 3+ years industry experience including 2 years in a CRO; experience as a mentor, team leader or manager (Preferred) 3) Must have advanced computer skills with expertise in SAS, StatXact and nQuery 4) Must have strong problem solving and creativity skills; proven leadership skills; good time management skills; the ability to prioritize, and multi-task 5) Excellent organizational skills with ability to work in a high volume and strict deadline environment 6) Excellent verbal and written communications skills 7) Ability to work independently and as a team member 8) Machines, Office Equipement & Software Knowledge such as SAS, StatXact and nQuery MS Office (MS Word, Excel, and Power Point)