Principal Biostatistician FSP - Medical Affairs
- Leads statistical support for post approval value evidence generation and reimbursement submissions
- Conducts post hoc analysis to support publications and presentations
- Reviews and authors abstract, manuscript, regulatory documents
- Collaborates with cross-functional team to support observational studies
- Develops statistical sections of study protocols and statistical analysis plans.
- Collaborates with Data Management and Medical Research on design of eCRFs.
- Provides statistical guidance on conduct of ongoing studies.
- Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs
- Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
- Contributes to scientific articles, summarizing data collected in sponsor studies.
- Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.
- PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.
- Excellent written and oral communication and presentation skills.
- Strong SAS programming experiences and expertise and are comfortable delivering analysis outputs without programmers support.
- Extensive experiences working on data analysis with clinical studies database
- Experience working on post-approval observational and clinical studies.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Experiences in R programming language and other statistical software.
- Experience with CDISC, including SDTM, ADaM, CDASH.
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