What are the responsibilities and job description for the Director / Senior Director, Regulatory Affairs position at Tempus?
Working as leading statistician on multiple studies / projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR).
Participate in study related activities and provide statistical consultation, input and guidance to cross-functional groups.
Develop and / or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others.
Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities.
Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate in activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected.
Provide statistical expertise by identifying potential issues, providing recommendations and bringing in statistical experts external for relevant issues as needed.
Requirements
Ph.D. in Biostatistics or statistics.
At least 4 years of pharmaceutical clinical trial experience.
In-depth knowledge of clinical trials methodology, regulatory requirements, statistics.
Comprehensive experience of SAS programming and R / S language.
Ability to effectively collaborate in a dynamic environment.
Excellent practical, organizational, interpersonal, oral and written communication skills are a must.
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