Principal Biostatistician

Principal Biostatistician

Position based in King of Prussia, PA or Waltham, MA. This is a hybrid role requiring onsite presence a minimum of 3 days per week.

You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician will implement statistical strategies for clinical trials and regulatory submissions within the program and is accountable for the statistical deliverables.

• Provide input to statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Lead and fully support biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.
• Author the initial statistical analysis plan for clinical trials and regulatory submissions, ensuring timely completion and quality.
• Support biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
• Interpret analysis results and ensure reporting accuracy.
• Manage outsourcing operations or work with internal statistical programmers, ensuring timeliness and quality of deliverables by CRO/FSP, and conduct reviews to guarantee quality.
• Account for the TFL/CDISC package for study report and regulatory submission.
• Provide statistical thought partnership for innovative study design and clinical development plans, including go/no‑go criteria and probability of technical success calculations.

• PhD or MS in Biostatistics or Statistics.
• 7+ years of relevant work experience in the pharmaceutical industry and/or CRO.
• Experience managing a CRO or having worked in a CRO.
• Experience providing statistical leadership at a study level.
• Demonstrated statistical contribution in facilitating and optimizing clinical development.

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit