Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created.
Collaborate with data management in the planning and implementation of data quality assurance plans.
Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
Effectively justify methods selected and implement previously outlined analysis plans.
Conduct peer-review of work products from statistical colleagues.
Effectively utilize current technologies and available tools for conducting the clinical trial analysis.
Communication of Results and Inferences
Collaborate with other statistical colleagues to write reports and communicate results.
Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers.
Assist or respond to regulatory queries working in collaboration with other statistical colleagues.
Therapeutic Area and Systems Knowledge
Understand relevant disease states in order to enhance the level of customer focus and collaboration.
Ensure replication of tools and systems, where applicable and stay informed of technology advances.
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable corporate, medical, local, and departmental policies, procedures, processes and training.
B.S, M.S, PhD, or equivalent experience
Statistics, Biostatistics, Computer Science, Epidemiology, or equivalent of field study
At least 6 years clinical trial working experience
CDISC standard hands-on working experience, including writing specifications and programming of SDTM, ADaM, and TFL
Proficiency in the SAS programming language
Capability of working independently
Interpersonal/teamwork skills for effectiveness interactions
Technical growth and application with working knowledge of statistics and statistical software
Self-management skills with a focus on results for timely and accurate completion of completing deliverables
Creativity and innovation
Demonstrated problem solving ability and attention to details