The Principal/Associate Director of Biostatistics will be a key member of one or more clinical project teams who will be responsible for statistical aspects of clinical development of the studies in one or more clinical project teams. Specifically, he or she will be responsible for the statistical decision making, innovative statistical design, modeling and simulation, and external collaborations on project level.ncy and efficiencies.
- Serve as biostatistics lead for one or more studies in a project team, providing statistical expertise in study design, study operation, decision rule and analysis plan etc.
- Author and/or oversee production of statistical sections of protocols, statistical analysis plans, and statistical sections of publications in one or more clinical projects etc.
- Manage junior biostatisticians.
- Plan, manage and oversee CRO statistical activities.
- Provide guidance to junior statisticians and statistical programmers on SDTM/ADaM and TLFs specifications development and programming, and perform quality checks of statistical programming as necessary.
- Perform other duties as requested.
- PhD or MS in statistics or biostatistics. PhD is preferred.
- Minimum 7-year (for PhD) or 10-year (for MS) experience on clinical trials is required.
- Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trial.
- Strong statistical leadership in a multi-functional project environment: able to manage many projects simultaneously as well as conflicting priorities.
- Effective writing and communication skills: able to author various statistical documents; able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report.
- Experienced with SAS programming and other statistical software.
- People management is a plus.
Job Location: Cambridge, MA
Equal Opportunity Employer
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