Job Title: Biostatistics Project Lead

Location: Germany (Remote)

Employment Type: Full-Time

About the Role:
BioTalent is thrilled to partner with a leading global pharmaceutical company to recruit an experienced Biostatistics Project Lead to join their high-performing team in Germany. This pivotal role offers the opportunity to oversee and lead biostatistical activities for innovative and large-scale clinical trials, driving data-driven insights that advance cutting-edge drug development.

As the Biostatistics Project Lead, you will manage and mentor a team of statisticians while collaborating with cross-functional teams to ensure the delivery of robust and regulatory-compliant statistical outputs.

Key Responsibilities:

• Lead and oversee the planning, execution, and delivery of biostatistics activities across multiple clinical studies, ensuring high-quality deliverables.
• Serve as the primary biostatistical point of contact for project teams, clients, and regulatory authorities.
• Provide strategic input into the design, analysis, and interpretation of clinical trials, including writing statistical sections for protocols and study reports.
• Develop and review statistical analysis plans (SAPs), ensuring alignment with study objectives and regulatory requirements.
• Collaborate with data management and programming teams to ensure proper handling, analysis, and reporting of clinical trial data.
• Participate in regulatory submissions and interactions, including preparing responses to health authority queries and representing biostatistics in regulatory meetings.
• Mentor and manage junior statisticians, providing guidance on technical and professional development.
• Stay up-to-date with industry trends, regulatory guidelines, and advancements in biostatistics methodologies.

Candidate Profile:
This role is ideal for a proactive, detail-oriented professional with extensive experience in biostatistics, excellent leadership skills, and a passion for driving innovative solutions in clinical trials.

Qualifications:

• Education: Master’s or PhD in Biostatistics, Statistics, Mathematics, or a related field.
• Experience:
  • Minimum of 5-8 years of biostatistics experience in the pharmaceutical, biotechnology, or CRO industry.
  • Proven track record of leading biostatistical activities for Phase I-IV clinical trials.
  • Strong understanding of regulatory requirements and guidelines (e.g., EMA, FDA, ICH).
• Expertise in statistical software such as SAS, R, or equivalent tools.
• Solid knowledge of clinical trial design, data analysis, and reporting.

Skills:

• Exceptional leadership and project management skills, with the ability to manage multiple projects and deadlines simultaneously.
• Strong problem-solving abilities and a results-driven mindset.
• Excellent written and verbal communication skills in English; proficiency in German is a plus.
• Collaborative team player with the ability to build strong relationships with cross-functional teams and stakeholders.

What’s on Offer:

• Competitive salary and benefits package.
• Opportunity to work with a global leader in pharmaceutical innovation.
• Flexible hybrid working arrangements for a healthy work-life balance.
• Professional growth and development opportunities in a supportive environment.
• The chance to contribute to life-changing therapies and innovations in healthcare.

How to Apply:
If you’re an experienced Biostatistics Project Lead looking for your next career move, we’d love to hear from you! Please send your CV.