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Director, Biostatistics

Brisbane, CA, USA | BridgeBio

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    10-12 years
Job Description:
96 people have viewed this job

Reporting to the Head of Biometrics,  this individual may be called upon to partner with other functional areas to provide statistical input on the design, execution, data analysis and interpretation of clinical trials for infigratinib. In addition, this individual may be the accountable statistican for regulatory interactions for the assigned trials, and support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND, NDA, MAA, and ROW filings.

Requirements:

Strategically partner with Clinical Development, Regulatory, and Clinical Operations expertise areas to provide statistical input into the design, execution, data analysis, and interpretation of oncology and/or achondroplasia clinical trials

Lead data analysis and interpretation for CSRs, marketing applications, manuscripts, abstracts, and other publications

Leverage advances in the field and, where appropriate, employ innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials

Identify and implement solutions to statistical and data analysis issues related to clinical trials & regulatory submissions

Effectively communicate and discuss complex statistical & drug development issues with R&D Leadership Team, and other Key Leaders, and influence portfolio strategy

Be the accountable statistician for regulatory interactions for assigned trials

Support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND, NDA, MAA, and ROW filings

Identify and lead efforts to improve data infrastructure and processes to support needs of Clinical Development, and adjacent expertise areas, such as pharmacovigilance and medical affairs

Ensure scientific integrity & timely availability of all data management and biostatistical deliverables

Actively manage resources and staffing to ensure a nimble and motivated team and efficient and high quality deliverables

Adept and motivated to improve both strategic and operational excellence; willing to “roll up his/her sleeves and do what it takes” to achieve critical program deliverables

Can exert good judgment regarding when to elevate issues above the team level

Possesses effective communication skills; is an active listener and fosters a team climate of open and honest communication

Invites input from others and shares ownership for team success

Remain current with FDA and international regulatory guidance relevant to oncology and orphan drug development

Education, Experience & Skills Requirements:

Ph.D. in Biostatistics or Statistics or related fields with 10+ years of biotechnology/pharmaceutical biostatistics experience

Experience managing teams of Statisticians and SAS Programmers

Ability to partner and provide strategic depth in oncology and orphan drug therapeutic areas

NDA, MAA submission experience required

Experience across all areas of development, from FIH through filing and post-marketing across a variety of therapeutic areas desirable

Experience with analysis of real world data and companion diagnostic bridging study desirable

Experience interacting with U.S. and Global regulatory authorities, including NDA/BLA/MAA filings


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