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Director, Clinical Data Management Programming

Mainz, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US   |   full time   |   Job ID: 9736 

 

 

Job Summary:


We are seeking a visionary Director of Clinical Data Management Programming to lead and advance our clinical programming and database setup capabilities. This critical role ensures strategic alignment, regulatory compliance, and operational excellence in support of global clinical trials and regulatory submissions. You will play a pivotal role in driving innovation, championing data integrity, and fostering collaboration across multidisciplinary teams.

 

Responsibilities:

 

  • Develop and implement a forward-looking vision for clinical data management programming to support global clinical trials and regulatory submissions.
  • Lead the development of GCP-compliant programming assets, including EDC studies, exception listings, patient profiles, data visualization tools, and automated workflows using base and advanced SAS, R, Python, or other programming languages.
  • Ensure consistency, harmonization, and audit readiness across programming standards, tools, and processes.
  • Partner with QA, regulatory teams, and cross-functional stakeholders during audits, inspections, and submission activities.
  • Provide technical support and administration for Medidata Rave applications, including iMedidata, Classic Rave, Rave EDC, Business Objects, and Coder.
  • Develop AI-driven reports, dashboards, and tools for EDC-related metrics and data insights.
  • Champion adherence to GCP, ICH guidelines, CDISC standards, and CDASH principles in clinical database creation and maintenance.
  • Mentor and guide the CDM programming team, fostering a culture of excellence, innovation, and continuous improvement.

 

Qualifications:

 

Education

  • Bachelor’s degree in computing, engineering, or a scientific discipline (or equivalent experience).

 

Experience

  • 12+ years of clinical data management experience in biotechnology, CRO, or pharmaceutical industries.
  • 10+ years of expertise in Electronic Data Capture (EDC) study build, administration, and DM programming (including custom functions and reports using SAS, SQL, Oracle, and Medidata Rave).
  • Proven experience in Medidata applications and system administration.
  • Advanced SAS programming (Base SAS, SAS/Stats, SAS/Graph, SAS/Macro), SQL, Spotfire and RDMS expertise.
  • Deep understanding of clinical drug development processes, data management systems, and regulatory requirements.
  • Exceptional problem-solving abilities, organizational skills, and communication skills. Ability to thrive in a fast-paced, collaborative environment.

 

 

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.

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