Role Overview
This position will execute and communicate high‑quality observational studies. The role is cross‑functional, partnering with clinical, regulatory, biometrics, safety, and commercial teams to deliver impactful evidence that supports decision‑making across the organisation.
Key Responsibilities:
- Execution of observational research across early and late‑stage development.
- RWE support for regulators and payers including registries and burden‑of‑illness work.
- Development of RWE methodologies including historical controls and analytical approaches.
- Performance tracking through dashboards and project metrics.
- Cross‑functional communication of complex observational methods to diverse audiences.
- Stakeholder management across internal teams and external experts.
- Protocol and document writing including protocols, SAPs, and clinical study reports.
- Regulatory input for filings, responses, and agency interactions.
- Engagement with investigators, thought leaders, advisory boards, and patient groups
Basic Qualifications:
- Scientific degree (MSc, PhD, MD, PharmD).
- Background in biostatistics, epidemiology, HEOR, or outcomes research.
Preferred Qualifications:
- PhD in a relevant scientific discipline.
- Experience in hematology/oncology.
- Experience with post‑marketing authorization studies (PAS/PMAS).
- Formal training in epidemiology or health services research.
- Strong track record in observational study management and data analytics.
- Experience with systematic literature reviews.
- Advanced knowledge of observational study design.
- Ability to translate complex findings into clear, non‑technical insights.
- Strong communication and stakeholder‑management skills.
- Proficiency in R, SAS, SPSS, or Stata.