Principal Biostatistician (Germany) en Jobgether

Description

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Biostatistician in Germany.

This role offers the opportunity to lead biostatistical efforts across multiple clinical trials, ranging from Phase 1 to Phase 4, providing oversight and guidance to ensure high-quality, compliant deliverables. You will serve as the primary statistical expert, advising on trial design, sample size calculations, risk-based monitoring, and analysis plans while collaborating with cross-functional teams. The position requires strategic thinking to optimize biostatistical processes, manage budgets, and support statistical programming teams. You will contribute to regulatory submissions, mentor colleagues, and drive internal initiatives to enhance efficiency and quality. As a trusted subject matter expert, you will ensure statistical rigor, ethical compliance, and timely delivery across studies. This role combines leadership, technical expertise, and direct impact on clinical development outcomes.

Accountabilities:
• Act as Lead Biostatistician on multiple Phase 1–4 clinical trials and provide program-level oversight.
• Review and develop statistical sections of protocols, including sample size calculations and validation.
• Create, review, and approve Statistical Analysis Plans (SAPs) and Table, Listing, Figure (TLF) shells.
• Lead Unblinded Biostatistics teams for randomization and interim analyses.
• Collaborate with Data Management and Statistical Programming teams to ensure high-quality deliverables.
• Monitor budgets, timelines, and scope, providing estimates for out-of-scope work and ensuring financial accuracy.
• Support regulatory submissions, interpret clinical trial results, and provide statistical insights to stakeholders.
• Drive internal initiatives to improve efficiency and quality of biostatistical activities and deliverables.
• Act as Subject Matter Expert (SME) and provide coaching or training on biostatistics topics.

Requirements

 • Master’s degree or PhD in Statistics, Biostatistics, or a related field with applied clinical trial experience.
• At least 10 years of clinical trials experience in Biotechnology, Pharmaceutical, or CRO environments.
• Minimum 7 years as Lead Biostatistician for Phase 1–4 clinical trials.
• Strong knowledge of drug development processes, ICH guidelines (E6(R2), E9, E9(R1)), and relevant regulatory standards (FDA, Health Canada).
• Extensive experience with clinical trial data, SAPs, TLFs, and CDISC standards.
• Advanced SAS programming skills for clinical data analysis.
• Strong organizational, project planning, and time management abilities.
• Ability to work independently and collaboratively in a fast-paced environment.
• Excellent verbal and written communication skills in English; French is a plus.
• Experience leading internal initiatives to enhance quality or efficiency is advantageous.

Benefits

 • Flexible work schedule and home-based position.
• Ongoing learning and professional development opportunities.
• Collaborative and stimulating work environment with opportunities for advancement.
• Exposure to cross-functional teams and international projects.
• Inclusive workplace committed to diversity and equitable treatment.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.
The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.
Thank you for your interest!

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