Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID: 11349
About the role:
As Director of Statistical Programming with focus on Infectious Diseases you will work alongside the Head/Sr. Director of Statistical Programming as portfolio lead for the Infectious Diseases therapeutic area (e.g., COVID‑19, malaria, monkeypox, HIV, HSV, tuberculosis), implementing a comprehensive statistical programming strategy that maximises efficiency and quality across the portfolio while ensuring alignment with corporate and regulatory requirements.
Your main responsibilities are:
- Work alongside the Head/Sr. Director of Statistical Programming as portfolio lead for the Infectious Diseases therapeutic area (e.g., COVID‑19, malaria, monkeypox, HIV, HSV, tuberculosis), implementing a comprehensive statistical programming strategy that maximizes efficiency and quality across the portfolio while ensuring alignment with corporate and regulatory requirements
- Oversee statistical programming deliverables across multiple Infectious Diseases programs and studies (early- and late-stage), including analysis datasets (e.g., SDTM, ADaM), tables, listings, and figures (TLFs), integrated summaries, and other regulatory deliverables. Ensure programming strategies are aligned with compound/platform objectives, indication‑specific needs, and regulatory expectations
- Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs, rolling submissions, emergency use authorizations) for Infectious Diseases assets, ensuring compliance with eCTD requirements, and high‑quality, submission‑ready datasets, TLFs, and documentation (e.g., define.xml, reviewers’ guides)
- Work alongside the Head/Sr. Director of Statistical Programming as portfolio lead for the Infectious Diseases therapeutic area (e.g., COVID‑19, malaria, monkeypox, HIV, HSV, tuberculosis), implementing a comprehensive statistical programming strategy that maximizes efficiency and quality across the portfolio while ensuring alignment with corporate and regulatory requirements
- Oversee statistical programming deliverables across multiple Infectious Diseases programs and studies (early- and late-stage), including analysis datasets (e.g., SDTM, ADaM), tables, listings, and figures (TLFs), integrated summaries, and other regulatory deliverables. Ensure programming strategies are aligned with compound/platform objectives, indication‑specific needs, and regulatory expectations
- Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs, rolling submissions, emergency use authorizations) for Infectious Diseases assets, ensuring compliance with eCTD requirements, and high‑quality, submission‑ready datasets, TLFs, and documentation (e.g., define.xml, reviewers’ guides)
- Develop and oversee data standards, tools and automation for efficient production and verification of derived datasets (e.g., SDTM and ADaM) and TLFs, including portfolio‑wide solutions for recurrent endpoints (e.g., virology, immunogenicity, efficacy and safety outcomes) in infectious diseases
- Drive the creation, review, and validation of SAS/R programs for clinical data analysis across multiple infectious disease studies and integrated analyses, ensuring compliance with SOPs, regulatory standards, and principles of reproducibility and traceability
- Collaborate cross‑functionally with Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Translational Medicine, and other stakeholders to meet project deliverables and timelines for statistical data analysis and reporting across the Infectious Diseases portfolio
Represent statistical programming in clinical study teams, portfolio governance, protocol reviews, and submission readiness meetings
- Guide and collaborate with internal Global Biometric Sciences (GBS) project leads and CRO/FSP staff to ensure alignment with established data, analysis, and quality standards. Provide direction and oversight to external partners delivering programming services for Infectious Diseases projects
- Champion the adoption of advanced analytics, automation tools (e.g., SAS macros, R/Python workflows), and new technologies (e.g., AI/ML, data visualization, decentralized trials, real‑world evidence) within the Infectious Diseases portfolio to enhance programming efficiency and scientific insight
What you have to offer:
- 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 infectious Diseases
- Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
- Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
- Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Solid understanding of the drug development process from early- to late-stage development and submission
- Expertise in the requirements and technology to support electronic submissions
- Strong project and portfolio management skills
- 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 lead cross-functional teams and influence stakeholders in a matrix organization
- Ability to work in a fast-paced and dynamic environment and manage multiple programs simultaneously
- Strong analytical and problem-solving skills, with a focus on innovation, automation, and continuous improvement
Your benefits and remuneration:
If the position is filled in the US, the Expected Pay Range is $168,000/year to $268,700/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.
