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Job #02793

About our client Our client is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The company has also developed small molecules to treat various other autoimmune and inflammatory conditions. Position Location Senior Manager (Biostatistics) Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide guidance to statisticians and programmers on statistical analysis and programming 2) Develop and review Statistical Analysis Plan, mock-up tables and analysis datasets specification documents for clinical study protocol 3) Provide statistical input to clinical development protocol and CRF design 4) Ensure adherence to project timelines 5) Develop and administer biostatistics group budget 6) Select, develop and evaluate personnel to ensure efficient operation of the function 7) Monitor CRO’s progress on adherence to project timelines and the quality of deliverables 8) Develop detailed project task lists and timelines 9) Ensure quality of the final statistical analysis results 10) Track progress toward completion of analytical programs 11) Work with the Senior Director of Biometrics to adjust resources (as necessary) to effectively and efficiently address Biometrics’ priorities 12) Interface with consultants and other functionaries on statistical or data analysis-related issues 13) Conduct and ensure quality of assigned statistical analyses 14) Implement SOPs 15) Work with biometrics management in developing the biometrics infrastructure 16) Maintain contact with external statistical service providers and internally with all company employees 17) Provide guidance to statisticians and statistical programmers in supporting company clinical development projects and on assignment basis (as needed) to other functional areas 18) Perform all other related job duties as assigned or requested by department or company management Requirements 1) Master’s/Ph. D. in Statistics or equivalent 2) Minimum 10 years of related experience (statistical analysis of pharmaceutical clinical trial results) with a Master’s or 8 years of related experience with a Ph. D. 3) Minimum 3 years of supervisory and managerial experience 4) Experience in Survival Model preferred 5) Demonstrated experience in planning, organizing and achieving goals 6) Expertise in statistical methodology, software languages and computer systems 7) Proficient in SAS Base/Stat/Graph/IML programming 8) Good computer (Windows) skills 9) Ability to determine proper statistical methods and procedures on new assignments 10) Ability to handle multiple projects simultaneously 11) Ability to communicate complex statistical issues clearly to colleagues with limited statistical knowledge 12) Ability to cooperate with coworkers in creating smooth workflow and productive group 13) Attention to detail 14) Self-motivated with ability to use their own initiative