Gerente de Evidências de Vida Real (RWE) e Epidemiologia - Divisão de Farmacêuticos Estabelecidos (EPD) - São Paulo/ SP

Descripción del puesto:

JOB DESCRIPTION:

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
* Career development with an international company where you can grow the career you dream of.
* Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount on Abbott stock purchases, among others.
* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
* We offer flexible work policies that allow a healthy balance between personal and professional life
* We invest in the development of our employees through training and growth opportunities
* We foster an environment where every voice is heard and valued

The Opportunity
This position works out of our São Paulo Site and as a Real-World Evidence (RWE) & Epidemiology Manager you'll coordinates, provides and delivers methodological and epidemiological expertise to Real-World Evidence generation in Abbott's Established Pharmaceuticals Division (EPD). In this matter supports Clinical Development and/or Medical Affairs in clinical studies and related activities on the EPD brands. Assures compliance with international and (as applicable) local regulatory guidelines, as well as EPD policies and standards.

What You'll Do
- Manages several projects (mainly RWE, occasionally interventional) and works across all therapeutic areas
- Directs the operational aspects of the methodological work of RWE research projects as outsourced to CROs.
- Main methodological contributor to the design, analysis, and reporting of all observational clinical studies such as epidemiological studies (surveys as well as (nested) case-control studies), cross-sectional studies, registry studies, secondary database studies
* Responsible for appropriate statistical methodology and endpoint definitions as part of the design of clinical studies and for the associated sample size determination. Writes and/or reviews the statistical part of the protocol to ensure that appropriate statistical methodology is applied to minimize confounding and biases as pre-requisite to turn real world data into real world evidence.
* Responsible for briefing the CRO to an appropriate conduct of statistical analysis of EPD Clinical Development studies. This entails review of the statistical analysis plan, participation in data reviews, review of study report tables, listings and figures.
* Incumbent approves the (statistical) analysis plan and the lock of the database
* Together with the medical responsible person, clarifies and communicates the results and conclusions in order to ensure the correct interpretation of the results by different users
* Supports dossier submissions and answers statistical and methodological questions related to the file.
* -Attends and presents at external meetings for Real World Evidence and Epidemiology (as Investigators Meetings, KOL (Key Opinion Leader) meetings, Regulatory Agencies)
* Responsible to drive the agenda for generating RWE out of RWD (real world data). Thereby fully exploits the potential of the data to enhance the knowledge of the compound through data driven projects
* Person-to-go-to in reviewing epidemiological, methodological issues on our compounds coming from literature (observational studies, registries, etc.)
* Keeps up to date in relevant methodological, epidemiological expertise and hereto reviews relevant literature. Attends conferences and courses. Disseminates literature, (draft) regulatory guidelines or related information to Biometrics and/or Clinical/Medical Affairs.
* Represents Biometrics in review of HEOR studies, pharmacoeconomic models, and Global Value Dossiers
* Contributes to Behavioral Design studies, including Adherence studies, w/wo use of digital means/tele

Required Qualifications
* PhD or MSc in (Bio)Statistics, Mathematics, Epidemiology or Health economics
* If degree in Statistics: additional training in epidemiology and RWE
* If degree in Epidemiology: additional training in statistics
* Professional at senior/principal level

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Clinical Affairs / Statistics

DIVISION:
EPD Established Pharma

LOCATION:
Brazil > Sao Paulo : Building 1

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Not Applicable