Join a dynamic team shaping clinical data standards to accelerate drug development, ensuring cleaner datasets and faster regulatory submissions. You’ll lead experts, drive best‑practice adoption, and collaborate across functions to deliver high‑quality data solutions.
What You’ll Do
- Lead and mentor a team of clinical data standards developers.
- Act as technical SME for raw data collection and cleaning standards.
- Oversee CRO and external partner activities related to standards.
- Ensure high quality of own and team’s standards deliverables.
- Drive development and implementation of clinical data standards across the organization.
- Represent standards function in cross‑functional forums and guide strategic decisions.
What You Need
- BSc/MSc in Information Sciences, Statistics, Computer Science, or Life Sciences.
- 8–15 years in clinical data standards or biometrics functions.
- Deep expertise in CDASH, SDTM, ADaM, and raw data collection standards.
- Proven ability to manage projects and lead multidisciplinary teams.
- Excellent written and spoken English communication skills.
- Strong understanding of the clinical development lifecycle.
Good to Have
- Familiarity with SAS, R, Python, Java, or similar programming languages.
- Capability to influence stakeholders on standards‑related decisions.
- Experience in risk management within data‑driven projects.
The Opportunity
The role offers a hybrid schedule—at least three days a week onsite—to collaborate with cross‑functional teams, and you’ll join a company committed to diversity, inclusion, and scientific impact.