Director Statistical Programming (Technology Solutions)
Activities and responsibilities
- Work with Head of Statistical Programming to implement global statistical programming ecosystem and provide strategic direction relating to vendor oversight, innovation in technologies, automation, processes, and standards to maximize efficiency in statistical analysis and reporting, ensuing alignment with company goals and regulatory requirements
- Lead the development and implementation of programming standards, best practices, and innovative solutions to enhance efficiency and quality
- Oversee the design, implementation, and maintenance of the statistical computing ecosystem (e.g., SAS, R, Python environments, cloud-based platforms) to support clinical trials and data analysis
- Ensure infrastructure being scalable, secure, and aligns with clinical trial needs, supports reproducibility, and complies with regulatory standards (e.g., FDA 21 CFR Part 11, GxP)
- Lead the creation, and standardization of reusable macros, scripts, and automation pipelines (e.g., SAS macros, Python/R workflows) to streamline dataset generation, TLF production, and validation.
- Establish governance frameworks for code quality, version control, and documentation.
- Promote automation for routine tasks (e.g., SDTM/ADaM mapping, QC checks) to reduce manual effort
- Evaluate and integrate emerging technologies (e.g. cloud-based platform, AI/ML models, natural language processing) into statistical programming workflows. Drive innovation by identifying opportunities to leverage new tools and methodologies for data analysis and visualization
- Provide technical guidance and training on advanced programming techniques, tools, and industry trends, fostering a culture of continuous learning and professional growth. Provide functional expertise in the development and implementation of BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
- Partner with IT, Data Management, and other functions to align SCE with enterprise data strategie and advocate for modernization
- Mentor teams on advanced programming techniques, automation best practices, and emerging tools
Qualification profile
- Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
- 15+ years (10+ years for advanced degree) experience in statistical programming within the pharmaceutical, biotechnology or CRO industry
- Extensive experience supporting regulatory submissions and familiarity with regulatory requirements (e.g. FDA, EMA, ICH guidelines)
- Advanced proficiency in statistical programming languages and tools, such as SAS, R, and Python
- Experience with statistical computing environment (SCE) and cloud-based platform (AWS, Azure)
- Hands-on experience developing and implementing macros, automation tools, and innovative solutions to improve efficiency and quality in statistical programming
- Familiarity with emerging technologies, such as machine learning, artificial intelligence, and data visualization tools
- Proven ability to manage multiple projects simultaneously and experience working in a global or matrixed organization, coordinating with external vendors and partners
- Mastery of SAS programming for clinical trial data analysis and reporting
- Proficiency in R and/or Python for advanced statistical analysis and automation
- Knowledge of CDISC standards and regulatory submission requirements
- Ability to identify and implement innovative solutions to complex programming challenges and strong problem-solving skills with a focus on automation and process improvement
Your Benefits:
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 the apply button.
Please note:
Only applications sent via the apply button 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.
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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.
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