Director, Clinical Data Management Programming (Cambridge, MA, US, MA 02139) at BioNTech

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; 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 US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US location and simply send us your documents using our online form.

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.