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发帖数: 243 | 1 老年级，要有相关经验
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The Senior Statistician is responsible for the planning and implementation
of valid statistical analysis of clinical trials and for providing
understanding of clinical/ pharmacokinetic study design, technical
leadership within the study team, and statistical regulatory guidance.
Objectives:
Specific responsibilities include planning and directing study-level
analyses and reporting activities internally and/or with external vendors
and programmers, including:
Developing, writing, and executing statistical analysis plans; reviewing
statistical outputs; reviewing and/or preparing clinical study reports.
Providing planned and ad-hoc data analyses, outputs and listings for study
reports, regulatory submission documents, advisory meetings, presentations
and publications.
Standardizing analysis methodology, study design, and reporting standards to
promote data integration across research programs.
Providing statistical guidance for development strategies, feasibility
studies, and regulatory efforts in US and globally.
Participating in CRF and database design.
Implementing internal reporting standards, SOPs, and quality control
including timeline and budget monitoring.
Engaging and collaborating with external statistical thought leaders and
expert consultants
Identifying study-level vendor requirements and participating in the
evaluation/ selection of vendors.
Required Qualifications:
PhD in statistics or biostatistics with a minimum of 5 years of relevant
experience or MS in statistics or biostatistics with minimum of 7 years of
relevant experience.
Experience with oncology indications and international/multi-country studies.
Knowledge of clinical study designs, common analysis methods, descriptive
and inferential statistics, and data presentation practices.
Knowledge of FDA and ICH regulations.
Knowledge of statistical programming languages (including SAS), software,
techniques, and processes.
Travel Requirements:
Minimal travel; some international travel may be required. |
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