Director, Biostatistics

Location
South San Francisco, CA, United States
Posted
Aug 29, 2020
Ref
1628966060
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.