Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; Munich, Germany | full time | Job ID: 11350
About the role:As Associate Director Statistical Programming you will be responsible for working with the Portfolio lead to implement global statistical programming strategy to enable successful project deliverables as well as for leading statistical programming deliverables (e.g., SDTM/ADaM datasets, tables, listings, figures) for assigned studies, ensuring alignment with protocols, statistical analysis plans (SAPs), and timelines.
Your main responsibilities are:- Manage internal programmers or external vendors (CROs) to maintain quality, consistency, and compliance with CDISC standards and regulatory requirements
- Hands-on review, validation, and troubleshooting of SAS/R programs for data transformation, analysis, and reporting. Ensure accuracy of efficacy/safety outputs, perform quality control (QC), and resolve discrepancies in collaboration with Biostatistics and Data Management teams
- Serve as the primary programming point of contact for study teams and partner with Biostatistics to interpret analysis requirements, with Clinical Operations to address data issues, and with Regulatory Affairs to prepare submission-ready materials (e.g., ISS/ISE, CSR appendices)
- Manage relationships with outsourced programming partners (CROs), including scope negotiation, timeline oversight, and quality audits. Anticipates resource needs and monitor resource allocation across studies to balance workload and ensure deliverables meet deadlines
- Develop and implement standardized macros, tools, or workflows to improve efficiency across studies
- Train junior programmers and CRO staff on BioNTech standards, best practices, and emerging regulatory guidance (e.g., FDA/ICH updates)
- Provide programming support to the regulatory submissions including data submission package and define.xml development
What you have to offer:- Bachelor's degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 10+ years (5+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
- Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
- Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
- Oncology and project management experience is required
- Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions
- Ability to work in a fast-paced, dynamic, and a team environment
Your benefits and remuneration:If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/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.
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.
