Senior Scientist Biostatistics

Gaithersburg, MD Contract Duration: 12-36 monthsRate: NegotiableSalary: NA $1.00Responsibilities:Excellent employment opportunity for a Senior Scientist Biostatistics in the Gaithersburg, MD area.Provides statistical expertise in the design of experimental work and the evaluation and interpretation of experimental results in research projects and clinical trials, referring to more senior Statistical experts where necessary.Manages own work to schedule/quality and will apply a range of Statistical methods.Able to solve complex problems within own area and will participate in multi- disciplinary teams.Biostatistics Contractor is a delivery focused role working under the leadership, oversight and direction of assigned Company Supervisor, responsible for activities relating to design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialization.The position requires sufficient experience working as a Statistician in the Pharmaceutical industry, to be able to independently perform and/or lead statistical work within a study, multiple studies, indication, or be recognized as a methodology expert.This individual is able to support and/or lead work either in house or partnering externally to ensure delivery to standards, quality and time.May serve as a supporting or lead statistician for a study, multiple studies, indication within a project (potentially as a Global Product Statistician) or a project-level activity, such as a regulatory or payer submission, responsible for statistical elements of the design, analysis, interpretation and/or reporting.Quantifies the benefit, risk, value and uncertainty of the emerging asset/product profile.Develops design options and provides high quality deliverables to support the business in making informed decisions.Contributes to statistical methodology advances by identifying new opportunities, investigating and applying novel statistical approaches, including modelling and simulation.Ensures high quality is built into own and other statisticians' deliverables.Ensures compliance with standards and external regulations.Contributes to the development of best practices to improve quality, efficiency and effectiveness within function.Plans and supports Team's project activities and tasks.Communicates and escalates risks within the assigned studies and/or projects.Collaborates internally and externally, to ensure delivery to standards, quality and time.Experience:MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in Pharmaceutical industry.Biostatistician with Late Phase Oncology experience.Very good SAS and R programming skills.Thorough knowledge of the Technical and Regulatory requirements related to the role.Experience in the study and/or program design, development, data analysis and interpretation, as well as regulatory interactions and/or submissions.Ability to proactively manage concurrent activities within a study or project.Ability to apply novel statistical methods to problem solving.Ability to manage relevant documentation.Excellent communication skills and ability to build strong internal and external relationships.Previous Therapy Area experience.