Job Description

JOB OVERVIEW
The Senior Biostatistician is responsible for the departmental efforts in developing and implementing innovative statistical methods in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. Additional responsibilities include providing leadership and statistical/strategic input to the clinical development plans and being a key contributor to clinical protocols for statistical concepts as well as broader drug development concepts.
JOB RESPONSIBILITIES
\xc2\xb7 Perform/oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to Sponsor, regulatory authorities, and the scientific community.
\xc2\xb7 Provide oversight of statistical analysis plans, statistical outputs, and other documents as required.
\xc2\xb7 Represent company and the statistical team on the Product Development Teams of sponsors.
\xc2\xb7 Provide statistical and methodological consultation on special statistical methodology or statistical, scientific, and regulatory issues.
\xc2\xb7 Collaborate with medical monitors and other study personnel on the creation of clinical trial designs.
\xc2\xb7 Perform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a design.
\xc2\xb7 Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements.
\xc2\xb7 Work with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by statistical programmers.
\xc2\xb7 Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
\xc2\xb7 Key contributor in project planning.
\xc2\xb7 Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
\xc2\xb7 Manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables, and processes.
\xc2\xb7 Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.