Associate Biostatistics Director
Current•Applies extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases•Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design•Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials•Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines•Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated•Review ADaM specifications and verify primary and secondary efficacy endpoints•Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications•Effectively manage CRO to ensure high-quality deliverables within timeline and budget•Oversee programming of ADaMs and TLFs for the study•Responsible for one or more studies with concurrent tasks and timelines•Participate in the validation/QC of key study endpoint analysis and submission deliverables•Apply appropriate regulatory guidelines to the projects•Guides the successful completion of major programs, projects and/or functions•Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy•Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals •Develops technical and/or business solutions to complex problems•Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results•Performs a variety of complicated tasks with a wide degree of creativity and latitude•Creates formal networks involving coordination among groups
