Biostatistical Programming Expert

Confidential; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Confidential seeks a highly experienced biostatistical programmer with oncology expertise to support four ongoing studies and CSR analyses. The role requires PhD-level qualifications and deep statistical programming experience in a clinical development setting.

The candidate will develop SDTM/ADaM datasets according to CDISC standards and program TFLs for efficacy and safety analyses, contributing to regulatory submissions in a fast-paced biotech environment.

Qualifications

• PhD-level or equivalent in statistics or a related field.
• Extensive statistical programming experience in clinical development.
• Strong oncology expertise in drug development.
• Experience overseeing active trials on sponsor side.
• Excellent communication and collaborative mindset.

Responsibilities

• Develop SDTM and ADaM datasets per CDISC standards.
• Create tables, figures and listings (TFLs) for efficacy and safety analyses for CSR submissions.
• Support regulatory submissions with analyses and documentation.

Skills

Statistical programming

Oncology drug development

Sponsor-side trial oversight

Strong communication

Startup environment adaptability

Education

PhD in statistics

Tools

SAS-LSAF

Job description

Business Driver

The client has ongoing trials and will be losing a key programming lead due to an organizational transition, creating a resource gap. The company is looking to fill this gap without increasing management headcount.

The Work

The client needs a strong biostatistical programmer with oncology experience to support four ongoing studies, including analyses for Clinical Study Reports (CSRs).

Activities include, but are not limited to:

Develop SDTM and ADaM datasets in accordance with CDISC standards

Program tables, figures, and listings (TFLs) supporting efficacy and safety analyses (e.g., RECIST-based tumor response, progression-free survival, overall survival) for clinical study reports and regulatory submissions

Professional Requirements: Technical Skills

• PhD-level or equivalent in a specialized science, ideally statistics
• Deep statistical programming experience in a clinical development setting
• Deep oncology experience in a drug development setting
• Experience with SAS-LSAF (nice to have)
• Must have significant sponsor-side experience independently overseeing active clinical trials
• Professional Requirements: Soft Skills (Must Have)
• Thrives in a startup-style environment with a highly collaborative and positive mindset
• Passionate, adaptable, and energized by fast-paced biotech work driving cutting-edge science
• Intellectually curious with an entrepreneurial, ownership-driven approach to work
• Learns and adapts to ongoing activities quickly
• Highly communicative while being proactive
• Excellent communication and writing skills, with a willingness to share knowledge and lessons learned, and strong attention to detail