Associate Director/Director, Biostatistics

Primary Responsibilities

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 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)
• Integrated summaries of drug efficacy and safety
• TFLs
• Interim analysis plan
• 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 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 bring 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.

Additional

We are open to providing relocation for this position.

The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.