Associate Director, Statistical Programming

Cambridge, US; Gaithersburg, US; New Jersey, US   |   full time   |   Job ID: 9872 

Responsibilities:

• Work with Portfolio lead to implement global statistical programming strategies that enable successful project deliverables.
• Lead the statistical programming deliverables (e.g., SDTM/ADaM datasets, tables, listings, figures) for assigned studies, ensuring alignment with protocols, statistical analysis plans (SAPs), and timelines.
• Manage internal/FSP programmers or external vendors (CROs) to maintain quality, consistency, and compliance with CDISC standards and regulatory requirements.
• Provide hands-on review, validation, and troubleshooting of SAS/R programs for data transformation, analysis, and reporting. Ensure accuracy of efficacy/safety outputs, perform QC, and resolve discrepancies.
• Serve as the primary programming point of contact for study teams, collaborating with Biostatistics, Clinicals, and Regulatory Affairs to ensure delivery of submission-ready outputs.
• Oversee CRO partnership, including scope negotiation, timeline oversight, and quality monitoring and audits.
• Anticipate resource needs and manage allocation across studies to ensure balanced workload and timely deliverables.
• Develop and implement standard macros, tools, or workflows to improve efficiency across studies. Train junior programmers and CRO staff on BioNTech standards, best practices, and emerging regulatory guidance.
• Provides programming support to the regulatory submissions including data submission package, define.xml, and CSR appendices.

Qualifications:

Education

• Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred

Experience

• 10+ years (5+ years for advanced degree) of statistical programming experience in pharmaceutical, CRO, or clinical research settings, with Oncology experience required
• Excellent knowledge of SAS (Base, Macro, STAT, GRAPH, SQL); working knowledge of R or Python a plus.
• Strong knowledge of regulatory requirements (FDA, EMA, ICH, and other global guidelines).
• Hands-on experience with industry data standards (CDISC SDTM, ADaM).
• Experience managing study-level programming deliverables and external CRO vendors oversight.
• Demonstrated project management skills with ability to coordinate multiple studies simultaneously

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.