Remote Associate Director, Biostatistics & Trials

BioSpace

Carlsbad (CA)

Remote

USD 172,000 - 258,000

Full time

12 days ago

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Benefits offered by this job

Discretionary annual bonus
Equity grants
Medical, dental and vision insurance
401k retirement plan
Flexible paid vacation

Job summary

Jazz Pharmaceuticals is seeking an Associate Director of Biostatistics to serve as statistical lead for drug development projects and trials. The role designs and reports Phase I–IV studies, collaborates across teams, and guides statistical strategy, analyses, and regulatory submissions.

The position may supervise statisticians and involves interaction with regulators, internal teams, and external vendors. A PhD/MS with extensive experience is required, preferably in oncology or hematology.

Qualifications

  • PhD with >4 years or MS with >6 years in statistics/biostatistics.
  • Experience with oncology/hematology preferred.
  • Knowledge of CDISC SDTM and ADaM standards; regulatory experience.

Responsibilities

  • Lead statistical strategy for Phase I–IV trials and regulatory submissions.
  • Develop and review SAPs, analysis plans, and data displays.
  • Collaborate with clinicians, data managers, and programmers to ensure robust analyses.
  • Present results to stakeholders and support publications and regulatory interactions.

Skills

Clinical trial design
Biostatistics leadership
Statistical inference
Regulatory knowledge

Education

PhD in statistics/biostatistics
MS in statistics/biostatistics

Tools

SAS
R

Job description

Jazz Pharmaceuticals is seeking an Associate Director of Biostatistics to serve as statistical lead for drug development projects and trials. The role designs and reports Phase I–IV studies, collaborates across teams, and guides statistical strategy, analyses, and regulatory submissions.

The position may supervise statisticians and involves interaction with regulators, internal teams, and external vendors. A PhD/MS with extensive experience is required, preferably in oncology or hematology.

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