Director Statistical Programming (CoE - Technology Solutions)
London, United Kingdom; Berlin, Germany; Mainz, Germany; Munich, Germany; Paris, France; Randstad, Netherlands | full time | Job ID:8853
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
Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables
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
Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and technologies
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.