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Director Statistical Programming (CoE - Technology Solutions)
Director Statistical Programming (CoE - Technology Solutions)BioNTech SE • Cambridge, MA, United States
Director Statistical Programming (CoE - Technology Solutions)

Director Statistical Programming (CoE - Technology Solutions)

BioNTech SE • Cambridge, MA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
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Cambridge, US; Berlin, Germany; Gaithersburg, US; London, United Kingdom; Mainz, Germany; Munich, Germany; New Jersey, US; Paris, France; Randstad, Netherlands | full time | Job ID : 8853

Your main responsibilities are :

  • 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

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 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
  • Expected Pay Range : $185,500 / year to $262,000 / 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.
  • 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.

    Inspired? Become part of #TeamBioNTech.

    BioNTech, the story

    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.

    Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

    Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

    BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

    BioNTech - As unique as you

    www.biontech.com

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