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Senior Biostatistician

Location: Greater Philadephia OR Boston
Work Model: Hybrid (3 days onsite per week)
Reporting To: Director, Biostatistics

Our client is an organization accelerating innovation to deliver greater impact for patients with Rare Diseases; their pipeline portfolio is diverse and ranges from early to late phase. With a project-led structure and a focus on collaboration, they’re building a future-ready team committed to developing therapies that make a meaningful difference worldwide.

They are currently looking for a Senior Biostatistician to provide statistical expertise supporting clinical development programs. In this role, you will contribute to the statistical strategy for clinical trials and regulatory submissions and support statistical activities across study design, data analysis, reporting, and submission preparation.

Responsibilities

• Contribute to statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Provide statistical support across data collection, analysis, reporting, and submission preparation.
• Develop and ensure the timely completion and quality of statistical analysis plans.
• Support interactions between Biostatistics and regulatory authorities such as the FDA, EMA, and PMDA.
• Interpret analysis results and ensure accuracy in statistical reporting.
• Collaborate with internal statistical programmers or manage outsourced programming activities within projects.
• Ensure quality and timeliness of deliverables from CROs or functional service providers (FSPs) and conduct review of outputs.
• Prepare and oversee TFL and CDISC packages for clinical study reports and regulatory submissions.
• Support process improvement initiatives and contribute to statistical infrastructure, standards, and scientific consulting.

Qualifications

• PhD in Biostatistics, Statistics, or a related field, with 1–2 years of experience in drug development, MS 3+ years in industry
• Advanced knowledge and training in the application of statistical methodologies within clinical development
• Direct regulatory interaction experience is strongly preferred