Location: Boston, MA (Hybrid)
Therapeutic Areas: CNS / Epilepsy
Job Overview: A newly created role reporting into the Associate Director, tasked with providing statistical support on clinical development programs and/or clinical trials.
- Provide input into the development of study protocols, write the statistical section of study protocols, develop statistical analysis plans, and analysis specifications for the programming implementation of statistical analyses.
- Provide statistical input into data management and programming deliverables (e.g., data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.
- Develop statistical programs, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications.
- Provide oversight of CRO deliverables.
- Ph.D. / MS in Statistics
- 1 - 3 years of statistical experience in the pharmaceutical or biotech industry
- Strong knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling, and analysis.
- Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus.
- Knowledge of CDISC standards, including ADaM requirements.
- Experience in CNS preferred.
- Experience in CRO management.
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