Principal Biostatistician , FSP - Permanent Homebased (m/w/d)

The Principal Biostatistician will serve as the statistical lead for clinical studies, providing scientific oversight, strategic guidance, and hands‑on statistical support across late‑phase clinical trials. This role requires a highly experienced biostatistician capable of working independently, representing the Biostatistics function within cross‑functional teams, and delivering high‑quality statistical input throughout study design, execution, and analysis.

Key Responsibilities

Statistical Leadership & Study Support

• Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.
• Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.
• Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.

Statistical Analysis & Methodology

• Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross‑functional partners, pharma statisticians, or from finalized protocols.
• Implement non‑standard or advanced statistical methodologies, such as:
  • Complex time‑to‑event analyses
  • MMRM and other longitudinal models
  • Methods aligned with estimands, including deep understanding of competing policies, assumptions, and analytical implications
• Perform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.
• Conduct sample size calculations using SAS or R, and justify design assumptions when engaging with clinical leadership.

Programming Collaboration

• Work closely with statistical programmers, providing clear direction, reviewing outputs, and ensuring alignment between the SAP and programming deliverables.
• Contribute hands‑on with SAS programming, including working with clinical datasets and performing analyses when needed.
• Experience with R, CRM systems, or advanced tools is considered an asset.

Cross‑Functional Engagement

• Actively participate in CTT meetings, offering statistical expertise and driving alignment across clinical, programming, data management, and medical writing partners.
• Proactively communicate with team members to anticipate needs, address issues, and ensure clarity on statistical approaches.
• Provide clear, influential explanations of statistical concepts to non‑statistical stakeholders.

Qualifications & Experience

• Advanced degree in Biostatistics, Statistics, or a related field (PhD preferred; Master’s accepted with significant experience).
• Proven experience working independently as a study statistician in late-phase (Phase II/III) clinical trials.
• Experience in pharmaceutical industry strongly preferred; CRO experience is a plus.
• Hands‑on expertise with clinical outcomes studies, including cardiovascular events, symptomatic endpoints, and quality‑of‑life measures.
• Demonstrated ability to implement complex statistical methods and guide cross‑functional teams through analytical decision‑making.
• Proficiency in SAS; working knowledge of R is advantageous.
• Experience with regulatory submissions and interaction with health authorities is a plus.