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 for Biothera.
Objectives
Specific responsibilities include planning and directing study-level analysis 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 analysis, 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.
- Identifying study-level vendor requirements and participating in the evaluation/ selection of vendors.
Candidate Qualifications:
Preference will be given to candidates with the following 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.
Contact:
Email resume to jobs@biothera.com. No calls please.