o Lead and supervise junior level biostatisticians and provide mentoring and guidance using positive, progressive, and proactive management style.
o Manage project teams of statisticians and programmers and ensure quality and timeliness of project deliverables.
o Acts decisively, exercises good judgment and make effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.
o Manage project budgets and forecast resources needed for studies.
o Participate in capabilities and bid defense presentations and assist with development of budgets and proposals
o Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios.
o Perform sample size calculations and write statistical methodology sections for inclusion in study protocols.
o Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions.
o Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable.
o Develop SAS programs to QC statistical tables/figures/data listings.
o Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor.
o Review and/or write the statistical methods and results sections of clinical study reports.
o Review and/or assist in writing publications.
o Review case report forms and data validation guidelines to ensure quality and integrity of study data collection.
o Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review.
o Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis.
o Make presentations in industry meetings sharing experiences/methods with the greater clinical trials community.
o Additional responsibilities as assigned by supervisor/manager.
Masters degree in statistics or biostatistics, PhD preferred. Knowledge of SAS statistical computing package is a must. Knowledge of other database management and statistical software packages is a plus.
Must have a minimum of 7 years of experience in clinical trials, including protocol design activities. Staff management experience is preferred.
• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
• Proficiency in SAS statistical programming.
• Knowledge of other statistical and data management software packages is a plus.
• Strong written and oral communication skills.
• Knowledge and experience with CDISC data standards and models.
• Strong project management and mentoring/leadership skills.
• In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to effectively manage multiple tasks and projects.
• Ability to clearly describe statistical techniques and interpret results.
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