Sr Biostatistician / Clinical Data Scientist

Senior Biostatistician / Clinical Data Scientist

full-time

Remote from anywhere in the U.S.

About The Role

We are seeking a Senior Biostatistician / Clinical Data Scientist who combines deep statistical expertise with strong R-based visualization, storytelling, and trial design experience. The ideal candidate can bridge the gap between pharma business needs, SAP/SAS specifications, and development teams, translating complex clinical requirements into actionable workstreams.

Key Responsibilities

• Provide statistical input and guidance on trial design, estimate specification, and analysis planning.
• Collaborate closely with clinical teams to ensure statistical approaches align with study objectives and regulatory expectations.
• Develop and maintain R-based visualizations and dashboards to communicate insights and support decision-making.
• Translate SAPs, business requirements, and clinical objectives into Jira tickets and actionable tasks for development teams.
• Communicate clearly across cross-functional teams, ensuring statistical rationale and clinical context are understood by non-statisticians and developers alike.
• Support submissions by preparing analyses and visualizations that are compliant, reproducible, and aligned with regulatory standards.
• Provide mentorship to junior statisticians and data scientists.

Required Qualifications

• Advanced degree in Biostatistics, Statistics, or related quantitative field.
• Extensive experience in clinical trial design, statistical analysis plans, and regulatory submissions.
• Strong R programming skills, including visualization, Shiny dashboards, or other interactive reporting tools.
• Familiarity with estimands, trial design principles, and clinical endpoints.
• Proven ability to communicate statistical and clinical concepts to business and development teams.
• Experience translating SAPs and business requirements into technical specifications or Jira tickets.

Preferred / Nice-to-Have

• Experience with SAS and CDISC standards (SDTM/ADaM).
• Knowledge of trial simulation, adaptive designs, or advanced modeling approaches.
• Experience with Posit (RStudio) or other clinical analytics platforms.
• Exposure to clinical trial storytelling and creating executive-ready visual outputs.

Key Skills & Attributes

• Strong analytical and problem-solving skills.
• Exceptional communication skills, able to convey complex statistical concepts clearly.
• Senior-level ownership: proactive, detail-oriented, and focused on delivering high-quality outputs.
• Collaborative mindset, able to work effectively with cross-functional clinical, regulatory, and development teams.