RWE Senior Expert - Special Patient Populations Job Atlanta area,Georgia USA,Research/Development

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.

Make your mark for patients 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 skills including training in the areas of epidemiology, pharmacoepidemiology, outcomes research, health economics, biostatistics, data science or related disciplines
Ability…