Associate Director Statistical Programming

Join BioNTech SE as Our Associate Director Statistical Programming in Cambridge or Mainz

Job ID: 7197

Become Part of the BioNTech Family

Join BioNTech, where over 5,000 pioneers are dedicated to addressing some of the world's most pressing scientific challenges. Our groundbreaking work in developing the COVID-19 mRNA vaccine in under a year is just one example of our commitment to medical innovation and ethical standards. Help us continue our mission to create transformative therapies that harness the immune system's potential to combat cancer and infectious diseases.

About the Role: Associate Director Statistical Programming

If you are looking to impact global health and thrive in an innovative, passionate, and united work environment, consider applying for the role of Associate Director Statistical Programming at either our Cambridge Erie Street or Mainz K1 location.

Key Responsibilities:

• Collaborate with the Director of Statistical Programming to refine global programming strategies, focusing on technological innovation and process automation.
• Lead the development of our global programming ecosystem to support successful project outcomes.
• Partner with Clinical Development teams or CROs to ensure we meet project deadlines and objectives efficiently.
• Independently handle the production and validation of programming deliverables crucial for study reports and integrated summaries.
• Anticipate resource allocation needs and collaborate with management to meet project demands effectively.
• Maintain rigorous quality control standards across all programming processes as per company guidelines and international regulations.
• Develop global programming standards and create tools that streamline dataset creation and verification processes.
• Support regulatory submissions by providing essential programming knowledge and documentation.

Requirements:

• A Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field. An advanced degree is preferred.
• At least 10 years of relevant experience (or 5+ years with an advanced degree) in pharmaceuticals, CROs, or clinical research settings.
• Proficiency in statistical programming with tools like SAS/Base, Macro, STAT, GRAPH, SQL, and others.
• Experience in oncology or infectious disease areas, with a preference for candidates with submission experience.
• Strong project management skills and a comprehensive understanding of regulatory guidelines from the FDA, EMA, ICH, and other bodies.
• Detailed knowledge of CDISC standards and data reporting in clinical trials.

Benefits of Working with Us

At BioNTech, we prioritize the health and well-being of our employees, offering competitive salaries and a range of benefits. We support a diverse and inclusive workplace and are proud to be an equal opportunity employer.

Ready to make a difference at BioNTech? Apply now for the position of Associate Director Statistical Programming at your preferred location through our careers site.

BioNTech upholds principles of equality and inclusivity, ensuring a workplace free from discrimination.