The company is a global leader in partnering with companies to transform and manage their business by harnessing the power of technology.
The role:
The Senior Statistician collaborates with team members (both internal and external) to provide high-quality, reliable statistical expertise and support.
Additionally. they perform and oversee quality control (QC) of data displays with inferential statistics. Also, Senior Statistician conduct QC analysis datasets prepared by others, maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications)
Qualifications:
● Contribute to design, analysis and reporting of clinical trials or other scientific research studies. Assist with development of protocols, statistical analysis plans and/or Table Figure, and Listing shells with details for execution and programming implementation. Work under supervision to implement sound statistical methodology in scientific investigations.
● Write and Review SDTM and ADaM Specifications for moderately complex studies.
● Perform Production and/or Validation Programming of SDTM, ADaM and TLFs for moderately complex studies.
● Assist in identifying scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Provide programming specifications for derived variables and analysis datasets. Collaborate with team members in preparation for database lock.
● Maintain a working knowledge of regulatory guidelines regarding clinical trial analysis and reporting.
● With supervision perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed upon timelines.
● Evaluate the appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
● With supervision, develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. Work collaboratively with cross-functional teams. Clearly explain statistical concepts to non-statisticians. Provide responses to questions and pursue analyses suggested by data under supervision.
● Build/drive cross-functional relationships and collaboration.
● Collaboration with US time zones to support periodical sponsor meetings and internal questions and meetings.
Requirements:
● Master’s degree in statistics, biostatistics or closely related fields, PhD preferred.
● Master with 4+ years (PhD 1+ year) of industry experience as a Study Statistician
● Ability to lead projects and manage team members and work collaboratively, effectively, and productively in diverse organization structures.
● Solid statistics background and training, working knowledge of advanced statistical methodologies and SAS programming skills; good understanding of drug development and experiences with clinical trial data analyses/preparation for submissions; good knowledge and understanding of regulatory guidelines.
● Advanced knowledge of SAS procedures.
Benefits:
● Family health plan.
● Birthday day off.
● Continuous training through content platforms.
And more!
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