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Senior Biostatistician
Location
United States
Posted
113 days ago
Salary
0
Seniority
Senior
Job Description
Senior Biostatistician
SuperStaff
• Providing statistical support to clinical studies • Participating in the development of study protocols, including participation in study design discussions and sample size calculations • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications • Performing statistical analyses and interpreting statistical results • Preparing clinical study reports, including integrated summaries for submissions • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Job Requirements
- Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
- Experience working for a CRO is strongly desired.
- Experience with oncology is a bonus.
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
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