RWE Senior Expert - Special Patient Populations

Senior RWE Expert

Make your mark for patients

About the role:

As a Senior RWE Expert, you will be responsible for designing and executing global real-world evidence (RWE) projects that:

• inform strategic internal decision-making thereby empowering differentiating R&D activities within UCB
• support external decision making by key stakeholder groups such as patients, regulators, policy makers, payers, and prescribers
• contribute to the wider epidemiological and medical understanding of specific diseases
• develop the underlying real world data infrastructure for a specific disease / disease area related to women of childbearing age (WoCBA) and other special patient populations (SPP), including elderly and pediatrics.

You will drive the development of the overarching RWE Functional Strategic Plan for an asset in close collaboration with the Strategy lead for WoCBA/SPP.

What you'll do:

• EXECUTION of RWE STUDIES on time and to budget:
• input to / help drive the Global RWE Strategy & Tactical WoCBA/SPP Plan based on request from the RWE Strategy Lead responsible for the respective patient population/asset
• E.g.:
  Epidemiology, Natural History/Burden, Care Pathways, Unmet Need;
  Gap analysis and new studies required for JCA;
  Background rates of safety outcomes;
  Regulatory studies including external control arms;
  Innovative hybrid study designs;
  Regulatory safety study commitments (PASS, PAES, PMS);
  Drug utilisation and early feedback post-launch;
  Comparative effectiveness including long term and patient centric outcomes;
  Data component of managed entry programmes / value-based contracts
• writing study concept; writing study protocol; developing SAP; meeting quality control and governance requirements, reporting against milestones; consultation to local study teams; mitigation for operational issues
• Leading Secondary Data Use Studies, including the most complex and high profile studies; and representing RWE on Primary Data Collection Study teams
• Collaborating with external vendors and medical experts on RWE projects,
• with BQS and RWE Analysts on the analysis plan
• Lead the interpretation of results and communicating results internally and externally
• Develop clearly defined evidence needs with
• the Evidence Synthesis group for HE/HTA and value communication plans
• Safety / Pharmacovigilance teams for regulatory needs
• Supporting the RWE Strategy Lead to develop the overarching RWE Functional Strategic Plan for an asset
• Provide strategic input to internal stakeholders based on RWE activities and robust epidemiological and medical understanding of WoCBA/SPP
• Identifying opportunities for innovative study designs, use of new data sources and advanced analytic techniques to solve complex evidence generation problems
• Consistently advocate for scientifically sound methods with internal and external stakeholders; being able to challenge and defend positions appropriately with a range of stakeholders

Interested? For this position you'll need the following education, experience and skills:

Minimum Qualifications:

• Master's Degree
• Experience successfully conceptualizing and delivering RWE projects using primary and secondary data (within the pharmaceutical industry or with a recognized expert consultancy or academic center of excellence)
• 6 years of Global or regional experience
• Excellent and effective oral/written skills in English

Preferred Qualifications:

• PhD in epidemiology or outcome research with additional depth and breadth of experience
• Ability to translate project work into scientific communications (e.g., abstracts, poster presentations, podium presentations, manuscripts)
• Combination of strong methodological quantitative knowledge, strategic, innovative thinking, and communication skills
• Experience in projects relating to fertility, preterm birth, obstetric illnesses, pregnancy, lactation and neonatal health AND/OR experience working with innovative RWE study designs and approaches
• Interested in incorporating advanced analytics, machine learning, and AI into traditional RWD approaches
• Background knowledge of industry trends and best practices, specifically related to epidemiology/outcomes research
• Subject matter expert with strong quantitative methods…