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Remote, 6-month contract with potential to renew

As direct report of the Head of RWE, you will apply your expertise in RWD analysis – pharmacoepidemiology – non interventional retrospective and prospective studies to co-develop and lead assigned project RWE analysis plans and co-design fit for purpose RWE -both regulatory and non-regulatory- aimed at advancing disease knowledge, patient care and value proposition of corporate brands, in line with strategic goals and medical/scientific standards in full support of/and collaboration with RWE program leads, clinical program leaders and core teams.

Main Activities

For the assigned project/product, consistently with the Global project strategy and in alignment and collaboration with the relevant cross-functional teams:

Develop and QC TFLs for protocols/reports/manuscripts from RWE research conducted to assess the value of therapies using RWD (eg. Registries, claims and EHR)
Conduct analyses and co-design observational studies, epidemiological studies, retrospective and prospective clinical registries, large electronic medical administrative registries
Perform feasibility assessments and identify of fit-for-purpose data for RWE research
Contribute to publication and dissemination of pharmacoepidemiology studies.
QC programming for descriptive and complex studies using RWD
Write the statistical analysis plans (SAP) for descriptive and complex studies using RWD
Work with RWE Program Lead to generate code lists for new measures in RWD
Drive the interpretation of analysis in collaboration with the cross-functional team and communicating analysis interpretation internally and externally.

Education

MSc in Biostatistics, Epidemiology, or related discipline such as Outcomes Research. Alternatives may include those with an extensive background of relevant experience i.e. Health Science disciplines (Medicine, Veterinary, Biology, Biotechnology, Pharmacy), even preferred in combination with PhD in Statistics/Epidemiology/Pharmacoepidemiology/Public Health/Outcomes Research.

Experience

Minimum 4-years experience in epidemiology, pharmacoepidemiology, non-interventional studies (prospective studies, patient registries, retrospective database studies), RWE generation at biopharmaceutical industry or CROs.

Technical Capabilities

Formal training in programming and demonstrated proficiency in statistical analysis programs commonly used in life sciences (e.g. SAS, R)
Ability to discern strengths and limitations of large real-world datasets — such as electronic health records, claims, clinical data registries, patient-generated health data, and other health data sources — in the context of data analysis in epidemiology studies
Successfully deliver global RWE/pharmacoepidemiology analysis from conceptualization to publication within the pharmaceutical industry (or with a recognized expert consultancy or academic center of excellence), using primary as well as secondary data, such as large healthcare databases, administrative registries, health economics and outcome research (HEOR)
Background knowledge of industry trends and best practices, specifically related to epidemiology/RWE/Outcome Research
Good knowledge and understanding of applicable regulations in pharmacoepidemiology, pharmacovigilance, clinical development, GCPs
Good understanding of biostatistics
Expertise in the EU5 and/or US healthcare environment a plus
Expertise in Respiratory Area represent a plus

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