Director, Biostatistics

Director, Biostatistics

Summary:

The Director of Biostatistics will be the statistical lead of a Principia clinical development project. This position will work collaboratively with cross-functional team to ensure appropriate study design, statistical analysis and reporting of clinical data in achieving regulatory, scientific and business objectives.

Functions and Job Responsibilities:

• Work collaboratively with clinicians, data managers, clinical programmers, clinical operations and regulatory affairs in clinical study planning, study conduct, data analysis and reporting
• Serve as lead biostatistician on clinical project to develop and execute statistical strategy, design, and analyses for clinical studies
• Provide guidelines and analysis specs to internal statistical programmers and/or biostatistics vendors, identify potential risks and address issues
• Manage biostatistics vendors, ensure timely delivery of planned TFLs, CDISC datasets, etc
• Responsible for writing statistical methodology section of the protocol, including sample size calculation
• Responsible for writing statistical analysis plans and mockup TLFs for individual studies and ISS/ISE
• Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports.
• Review and provide statistical input on study documents (protocol, CRF, IB, DSUR, etc)
• Work with department head and colleagues to develop, implement and maintain internal and outsourced biostatistics department standards and practices
• Collaborate with researchers and thought leaders in the planning of clinical development program and the publication of study data
• Perform and/or validate statistical analysis to support publication and conference presentation
• Be able to conduct independent research and resolve statistical methodological issues
• Perform ad hoc analysis and data validation as needed.
• Assist non-routine projects as applicable in support of clinical development activities

Qualifications:

• PhD in biostatistics or equivalent, with at least 15 years of relevant experience in biotechnology or pharmaceutical industry
• Excellent interpersonal and communication skills
• Solid knowledge of GCP, ICH guidelines, FDA regulations
• Experience with regulatory interactions (FDA or EMA)
• Good knowledge and skills of programming in SAS and/or R
• Demonstrated ability in providing statistical input and direction in clinical study designs, statistical approaches, interpretation of findings and crafting of key messages
• Demonstrated ability to collaborate and influence at the team level
• Experience of NDA/BLA is a must
• Experience of immune-mediated diseases is a plus

Principia Biopharma is an equal opportunity employer.