Director* Data Management Programming
- BioNTech Careers
- Cambridge, Massachusetts
- Research, development, teaching
Become a member of the BioNTech Family!
Director* Data Management Programming
- 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.
- Work with CDM, oversee vendor building of database structures / data entry forms using EDC based on predefined study design specification and align with CDASH standards.
- Work with CDM and other relevant functions, support in creation and maintenance of Global Library that is align with clinical data standards based on CDISC and Integrated standard modules (as appropriate and available).
- Works with CDM, oversee Programming of edit checks, derivations, and custom functions
- Configuration Mapping for study integrations including Safety Systems, Consolidated Clinical Views (CCVs), CTMS/EDC Configuration.
- Work with CDM and other relevant functions to review specification and oversight implementation for system integration like IRT with EDC
- Troubleshoots issues with EDC, working with EDC vendor, Clinical Digital Solutions, and IT as needed
- Serve as a primary technical point of contact for assigned studies & provide technical support during study execution and closure
- 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.
- Support the clinical data snapshot process & other database lock procedures.
- Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and company standards
- Promotes teamwork within study & functional teams, shares experiences and best practices
- Has practical experience with various software tools and technologies such as but not limited to PL SQL, SAS, JReview, MS Office Products, etc
- Automation of Manual checks from SAS datasets and EDC database
- Expert data listing/data visualization development skills for delivery and support of data cleaning, including:
- Patient Profiles to support Medical review
- Medical Coding and Local Laboratory Management visualizations
- Operational dashboards
- Any SAS ad-hoc reporting requirements required to support “Study Conduct” for the study
- Interact with cross-functional team members during study build and Migrations
- Initiate cross-functional process improvements and create efficiencies within programming processes
- Train junior programmers in performing their 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
- Clinical trial knowledge is required.
- 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
- Excellent communication skills organized and ability to lead tasks from concept to delivery
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
- Plus more benefits that will be shared upon hire!
Have we kindled your pioneering spirit?
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 7688 #LI-DCA (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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