Real World Evidence Data Scientist

4 mesi fa

Parma, Italia ClinChoice A tempo pieno

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.

**Scope of the role**:

- 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.

**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).

**The Application Process**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds:

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