Director Statistical Programming (Oncology)

About the Role:

As Director of Statistical Programming, you will play a critical role in advancing BioNTech’s mission to harness the power of science and innovation for patient impact. Partnering with cross-functional teams, you will lead programming strategies and contribute to global regulatory submissions, ensuring compliance with industry standards. This is your opportunity to influence study designs and optimize workflows in a dynamic environment that embraces advanced analytics and emerging technologies.

You will lead a team of internal programmers, functional service providers (FSPs), and CROs to ensure high-quality deliverables that support clinical development and regulatory success. Join us in shaping the future of statistical programming at BioNTech while driving innovation and excellence.

Your Contribution:

• Partner with the Head of Statistical Programming to define and execute strategies for vendor oversight, process automation, and adherence to industry standards
• Lead a team of programmers to deliver analysis datasets, tables, listings, figures (TLFs), and submission-ready datasets
• Develop, review, and validate SAS/R programs for SDTM/ADaM datasets and efficacy/safety outputs in compliance with SOPs and regulatory requirements
• Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs teams to influence study designs and submission strategies
• Drive programming contributions for global regulatory submissions (NDA, BLA, MAA) including define.xml files and reviewer’s guides
• Champion advanced analytics adoption (e.g., R, Python, AI/ML) to optimize workflows while mentoring teams on industry innovations
• Establish robust programming processes and infrastructure to enhance efficiency across studies

A Good Match:

• Bachelor’s degree in Statistics, Mathematics, Computer Science or related field; advanced degree preferred
• Expertise in statistical programming using SAS (Base, Macro, STAT, GRAPH, SQL)
• Solid understanding of FDA/EMA regulations and CDISC standards (SDTM/ADaM)
• Extensive experience in supporting electronic submissions (eCDT) for global regulatory agencies
• Proven project management skills with the ability to manage multiple projects simultaneously
• Strong leadership skills with experience overseeing internal teams and external vendors
• Passion for innovation with proficiency in emerging technologies like R or Python

If the position is filled in the US, the Expected Pay Range is $220,000/year to $265,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.