Real World Evidence Data Scientist

at  ClinChoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for a Real World Evidence Data Scientist to join one of our partner companies, a large biopharmaceutical company.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

EDUCATION AND EXPERIENCE:

• Minimum 4-year experience in epidemiology, pharmacoepidemiology, non-interventional studies (prospective studies, patient registries, retrospective database studies), RWE generation at biopharmaceutical industry or CROs.
• Purpose-driven and Patient-oriented.
• Can do and proactive attitude.
• Courage to challenge the status quo and innovate.
• Clear communication skills with internal and external stakeholders.
• Ability to work independently and as a team-player.
• Strong silos-breaking and cross-functional approach.
• Problem solving and project management.
• Fluent in English and local language(s).

SCOPE OF THE ROLE:

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 Client strategic goals and medical/scientific standards in full support of/and collaboration with RWE program leads, clinical program leaders and core teams.

MAIN JOB TASKS AND RESPONSIBILITIES:

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 Client 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.

SPECIFIC STUDY TASKS:

• 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 centre 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.