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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 is based in São Paulo in our Pharmaceutical Division As a Statistics Manager you’ll have the chance to manage several projects and works in more than one therapeutic area. What You’ll Do Contributes, and attends and presents at external meetings for Statistics (as Investigators Meetings, Regulatory Agencies, Advisory Boards) as applicable. Provides adequate and qualified statistical and methodological (including Real World Evidence) support to EPD, eg input into Clinical Development Plans, and EPD or Affiliate study protocols for both interventional and observational clinical 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. Be 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 Blind Data Reviews, review of study report tables, listings and figures. Incumbent approves the lock of the database and requests unblinding of the study for subsequent analysis. Together with the Clinical/Medical, clarifies and communicates the results and conclusions in order to ensure the correct interpretation of the results by different users. Supports dossier submissions and study publications and answers statistical questions related to the file/study. Purpose of integrated analyses of internal compound data bases that are accumulating, incumbent writes the strategic and more detailed integration plans and ensures proper execution. Fully exploits the potential of the data in order to enhance the knowledge of the compound through data integration and data utilization activities (meta-analyses, data explorations, integrated data analyses). Manage external study statisticians working on the analysis of EPD clinical trial data. Briefs CRO’s on methodological and statistical deliverables. Reviews statistical literature and attends conferences and courses in order to ensure a high statistical expertise and maintain proficiency: Works with other statisticians to acquire knowledge on new/improved statistical methodology. Keeps up to date in relevant statistical expertise and clinical content expertise. Required Qualifications Graduated in Statistics, or Biostatistics, or a related field Preferred Qualifications Demonstrated competence in experimental design and statistical inference. Thorough understanding of International Conference on Harmonization (ICH) Guideline and relevant regulatory requirements. Knowledge of observational study designs and experience with Real World Data/Evidence projects. Minimum 5 years experience as Statistician in pharmaceutical industry or CRO. Able to "explain" statistics to non-statisticians but also to defend statistical cases (e.g., study design features). The incumbent is a team worker, driving for quality, and pro-active, but also insistent on statistical issues. Works collaboratively with function management and multiple stakeholders to develop strategies for addressing issues/requirements that arise in clinical development and marketed products support. 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter