Responsible for the statistical activities and support on statistical solutions for tri-als / publications and conferences.
Activities include providing input on statistical sci-entific and operational aspects of the planning, design and reporting of tri-
als / experiments, and production and delivery of statistical deliverables and explora-tory analyses.
Support trial statistician in transcribing statistical analysis plans of clinical studies in-to computational solutions for the statistical programmer to implement.
Transcrip-tions include specifications of derived variables, specification and development of statistical computing solutions for inferential statistical analyses, tables and listings templates, and modern statistical graphics for key reporting documents like the clin-ical study report.
Ensure that documents, specifications, programs / macros are consistent and comply with Clinical Science Unit (CSU) / project / company standards / processes.
Assume responsibility for reporting and analysis execution for multiple studies. Re-sponsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-
hoc analyses. Expected to provide support for publications for individual clinical trials, and scien-tific analytical solutions.
Ensure high quality for all assigned deliverables and processes and ensure audit-readiness.
Responsible for ensuring statistical deliverables are provided to agreed timelines.
Maintain and build effective relationships with internal and external customers, utiliz-ing support of management as needed.
Collaborate with other line functions. Explain statistical concepts in a manner easily understood by non-statisticians, and provide adequate statistical justifications for ac-
tions / decisions / statements, when required.
Participate in non-clinical project activities as needed.
Take on role of mentor and provide support for Biostatistician 1.
MS / MSc (in Statistics or equivalent) with 2+ years relevant work experience or PhD (in Statistics or equivalent). Fluent English (oral and written) -
Working knowledge of / experience with SAS / R or any other business or research analytic software with an expertise in at least one type of software.
Statistical and computational knowledge and expertise in analytic aspects. - Excellent interpersonal and communication skills.
Good understanding of global clinical trial practices, procedures, methodologies. - Good understanding of regulatory requirements for design, analysis and reporting of clinical trials.