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BioNTech SE · 1 day ago

Director Statistical Programming (CoE - Technology Solutions)

Cambridge, MA

Full-time

Onsite

Director/Executive

$186K/yr - $262K/yr

15+ years exp

BioNTech SE is a biotechnology company focused on developing innovative therapies. They are seeking a Director of Statistical Programming to lead the implementation of a global statistical programming ecosystem and provide strategic direction in vendor oversight, automation, and process improvement to enhance efficiency in statistical analysis and reporting. The role involves overseeing programming standards, mentoring teams, and integrating emerging technologies into workflows to support clinical trials and data analysis.

Health Care

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

Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables

Qualification

SAS programmingStatistical programmingCloud-based platformsAutomation toolsR programmingPython programmingMachine learningData visualizationCDISC standardsProblem-solving skillsMentoringProject managementContinuous learning

Required

Bachelor's degree in Statistics, Mathematics, Computer Science or related discipline

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