What are the responsibilities and job description for the Director, Statistical Programming position at BioNTech AG?
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9896
- Partner with Head of Statistical Programming to define and execute a comprehensive programming strategy, including vendor oversight, process automation, and adherence to industry standards.
- Lead and oversee a team of internal/FSP programmers and CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs).
- Drive the creation, review, and validation of SAS/R programs for SDTM/ADaM datasets, efficacy/safety outputs, and integrated summaries, ensuring reproducibility and compliance with SOPs and regulatory standards.
- Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to influence study designs, statistical analysis plans, and submission strategies.
- Lead the programming contribution to global regulatory submissions (NDA, BLA, MAA), including submission ready datasets, TLFs, define.xml, and reviews’ guide.
- Champion adoption of advanced analytics, automation, and emerging technologies (e.g., R, Python, AI/ML) to optimize workflows and mentor teams on industry innovations.
- Establish and maintain robust programming processes, infrastructure, and SOPs to enhance efficiency and standardization across studies and submissions.
- Contribute to continuous improvement and global clinical initiatives to strengthen BioNTech’s clinical operation and data analysis capabilities.
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 15 years (10 years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting, with a focus on oncology.
- Expert knowledge of statistical programming in SAS (Base, Macro, STAT, GRAPH, SQL).
- Solid understanding of FDA, EMA, ICH, and global regulations and guidelines.
- Deep knowledge of clinical study data standards and reporting requirements, including CDISC (SDTM and ADaM).
- Thorough understanding of the drug development process across early- to late-stage development and submission.
- Demonstrated expertise in supporting electronic submissions (eCDT, define.xml, reviewer’s guides).
- Proven project management skills with the ability to oversee multiple concurrent projects and global vendors.
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.
Inspired? Become part of #TeamBioNTech.
BioNTech, the story
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!
BioNTech - As unique as you
www.biontech.com
