Date: 8 Dec 2023

Location: Nationwide, Germany, 81379

Company: Sigma-Chi Europe

Passion for Innovation. Compassion for Patients.

With over 7 years of experience and more than 200 employees in over 4 countries, Sigma-Chi is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Leipzig, Germany, and we have affiliates in 3 European countries and USA.

We are looking for a:

Director Biostatistics (m/f/x)

The position holder is responsible for leading biostatistical strategy and accountable for all biostatistical activities for Medical Affairs, Health Economics and Outcome Research and Health Technology Assessment for at least one compound by contributing to evidence generation plan, pricing authorities’ interactions and scientific communication.

The position holder will be responsible to coordinate other biostatisticians assigned to the same compound as well as interact and ensure alignment with data management and statistical pro-grammers.

The position will either be based in one of our offices in Europe or from home within one of these countries.

Roles and responsibilities:

Project Responsibility

• Accountable for all functional activities for at least one Compound
• Act as the functional expert within the assigned program, ensuring that activities for Evidence Generation are scientifically sound and that the evidence generated meets requirements of internal and external stakeholders
• Take responsibility as project lead for all deliverables performed by biostatisticians across the global / regional evidence generation activities
• May lead critical studies from design to analysis execution and interpretation and contribute to documents submitted to Regulatory or Pricing Authorities

Operational Excellence and Innovation

• Sponsor, lead and participate in initiatives to improve the harmonization and efficiency of processes and develop and implement innovative solutions
• Maintain current knowledge of industry best practice in statistical methodology
• May act as Subject Matter Expert for Biostatistics, by providing guidance and support to team members and cross-functionally
• Monitor regulatory guidance and industry best practices to formulate proposals for new functional standards

Line Management activities

• Lead a team including recruitment, coaching, mentoring, people development, talent & performance management
• May lead a cross functional project team

Vendor Oversight

• Responsible for providing senior governance, direction, and execution of oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, regulatory and other relevant guidelines
• Responsible for CRO selection

Personal skills and professional experience:

• Master’s degree or PhD (preferable) in statistics, mathematics or related fields
• At least 10 years of experience as statistician (with at least 3 in Pharma) supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting
• Experience in oncology Therapeutic Area or in late phase projects is an advantage
• Extended and up-to-date knowledge of statistical methods related to clinical studies and to HEOR/HTA applications
• Knowledge of CDISC standards and statistical software such as SAS and/or R
• Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research
• Demonstrated expertise in study design, conduct and execution
• Excellent English language skills 
• Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
• Good negotiation and project management skills 
• Demonstrated entrepreneurship and leadership and proactive problem solving
• Ability and interest to work remotely with