Director* Data Management Programming

  • BioNTech Careers
  • Mainz
  • Research, development, teaching
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Director* Data Management Programming

The Director* Data Management Programming is a Subject Matter Expert to provide leadership, guidance, oversight, and support to CDM (include vendors, Safety, and Clinical Development with the development and management of clinical databases (Phase 1- 4) and ad-hoc programming in support of DB Builds and Data Cleaning to ensure the quality, integrity, and completeness of our quality data.

Your main responsibilities are:
  • Configuration Mapping for study integrations including Safety Systems, Consolidated Clinical Views (CCVs), CTMS/EDC Configuration
  • Troubleshoots issues with EDC, working with EDC vendor, Clinical Digital Solutions, and IT as needed
  • Work with CDM, overseeing DM vendor and support protocol amendments and database enhancements / migrations for:
    • Making modifications/additions to database structures/data entry forms
    • Modifying/adding necessary edit checks and derivations
    • Updating any/all configuration mappings for study integrations that is impacted by the database changes
    • Developing a Test Migration Plan and performing all necessary testing in the electronic CRF Amendment process in EDC, including creating the test migration plan, performing the impact analysis & reconciliation of changes the database structures, new and existing production data before deploying the changes into Production
  • Work with CDM, program custom SAS Datasets from EDC data based on the specifications
  • Lead and support the development of external data transfers and interfaces with multiple systems as needed
  • Create data review Listing and data visualizations for Data Managers and Clinical Development and assist them during data cleaning activities

What you have to offer.

  • Bachelor's degree, preferably in computing, engineering, or scientific discipline or equivalent experience
  • 10+ years study database development experience in the pharmaceutical industry working with clinical trial data
  • EDC Study Builder with at least 5 years of hands-on experience building studies in an industry leading EDC platform
  • Thorough understanding of regulations (GCP, ICH Guidelines) and international standards (CDISC) as they apply to creation and maintenance of clinical databases; expert knowledge of CDASH
  • Knowledge about clinical studies
  • Subject Matter Expertise in “Study Set-up Unit” or “Study Build” for Clinical Data Management,
  • Practical experience with programming using SAS, SQL, JREVIEW or Spotfire

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 7693 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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