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Job #02578

About our client Our client is a biopharmaceutical company dedicated to discovering, developing and commercializing orally active drugs that address significant unmet medical needs. Primarily focused on the treatment of cancer and inflammatory disease, their proprietary drug development pipeline includes several small molecule drug candidates designed to regulate targets in therapeutically important biologic pathways. This company aims to be the most efficient inventor of therapeutic products in the pharmaceutical industry. Position Location Biostatistics – Associate Director/Director/Senior Director Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all aspects of the Biostatistics Department 2) Participate in Study Team meetings 3) Handle and project-manage all study team activities within Biostatistics according to agreed resource and timeline plans 4) Create statistical text for study concept documents and protocols (study design, endpoints, sample size and methods for analysis) 5) Review and approve randomization specifications 6) Create statistical analysis plans 7) Review and approve SDF dataset specifications 8) Create templates for tables, listings and graphs 9) Review and approve key study-related documents produced by other functions (e.g. CRFs, Data Management Plans, etc.) 10) Participate in the finalization of protocol deviations and analysis sets 11) Create flash reports 12) Unbind, load and check accuracy of Treatment Assignment Data 13) Approve database freeze 14) Create statistical text for CSRs, clinical publications and other communications 15) Plan and execute statistical review and QC of CSRs, clinical publications and other communications 16) Assist in planning and contribute to compilation of ISS/ISE 17) Participate in study and systems audits by CQA and external bodies 18) Respond to audit questions and findings 19) Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services 20) Contribute to decisions on selection of outsourcing partners 21) Participate in the development and review of SOPs and other controlled documents 22) Oversee the work of outsourcing partners and vendors at study level 23) Participate in strategy meetings 24) Contribute to strategy via writing statistical elements of GDP 25) Lead and project-manage all GDT statistical activities according to agreed resource and timeline plans 26) Develop and maintain standardized statistical approaches and methodology Requirements 1) MS/Ph. D with Statistics/Biostatistics major or emphasis in a related field 2) Minimum 8 years of post MS or 4 years of post Ph. D experience in designing and supporting clinical trials 3) Experience in supporting regulatory submissions and post-marketing activities 4) Experience in oncology or rheumatology/inflammatory disease preferred 5) Knowledge of state-of-the-art technologies in statistical applications 6) Knowledge and enthusiasm for enhanced clinical trials designs (e.g., adaptive designs) 7) A positive attitude, with an ability to manage change in a dynamic environment 8) Proven ability to work effectively in a team environment 9) Ability to evaluate and leverage to improve business processes 10) Excellent communication (oral and written) skills