The Statistical Scientist provides components of statistical contribution to a clinical development program.
The Statistical Scientist implements statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables.
RESPONSIBILITIES AND ACCOUNTABILITIES Support Biostatistics conduct in study data collection, data analysis, reporting, and submission preparation.
Be accountable for timely completion and quality of the statistical analysis plan.
Manage outsourcing operations within the responsible projects.
Ensure timeliness and quality of deliverables by CRO.
Conduct reviews of deliverables to ensure quality.
Support Biostatistics interactions with authorities( eg, FDA, EMA, PMDA) Be responsible for result accuracy in study report and regulatory submission documents.
Perform quality control of the CDISC deliverables.
Conduct ad hoc statistical analyses.
Support improvement initiatives and related standards for infrastructure / process / scientific consulting Education / Experience : PhD or MS in Biostatistics, Statistics, or related field 3 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting Statistical support in facilitating and optimizing clinical development programs Support to regulatory submissions desired Experience managing CRO preferred Competencies Advanced knowledge and training in applications of statistical methodologies Basic knowledge of clinical development and processes Ability to collaboratively work and provide leadership in matrix environment Strong interpersonal and communication skills (verbal and written in English) Proficient in SAS programming Desired expertise in Statistical methodologies CDISC, statistical programming, and / or data standards Biostatistics and Statistical Programming Operations Travel Requirements As needed Worker Type : Employee Worker Sub Type : Regular