Senior Biostatistician

Requirements:• 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. • Preferred Qualifications: Ph.D. in Biostatistics and 3+ years industry experience including 2 years in a CRO; experience as a mentor, team leader or manager. • Must have advanced computer skills with expertise in SAS, StatXact and nQuery Responsibilities:• 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. - The database, data collection guidelines, and computerized logic checks used to assist data management. • Create analysis plans detailing the objectives, statistical considerations, study populations, efficacy parameters, statistical methods and prototype tables, figures, and listings. • Manage: - Generation and implementation of the quality review process in conjunction with data management, biometrics, and programming support. - Implementation of analysis plans. • Provide guidance and training to Biometrics staff on statistical procedures, methods and concepts. • Write and review statistical reports; provide statistical expertise to the Medical -Writer for integrated clinical and statistical reports. • Design and manage generation of randomization schedules. • Provide statistical support, potentially serving as primary contact, to clients and internal project team members. • Provide input on statistical management for all projects and departmental operations. • Prepare and review FDA statistical responses. • Provide independent FDA representation. • Participate in the interviewing process for departmental candidates. • Participate in revising Biometrics policies, guidelines and operations. MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Southborough, MA 01745 JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee COMPANY: MRINetwork EMAIL: Apply by Email