Gerente Estatístico - Divisão de Farmacêuticos Estabelecidos (EPD) - São Paulo/SP at Abbott

São Paulo, State of São Paulo, Brazil

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Graduated in Statistics, or Biostatistics, or a related field
Demonstrated competence in experimental design and statistical inference (Preferred)
Thorough understanding of International Conference on Harmonization (ICH) Guideline and relevant regulatory requirements (Preferred)
Knowledge of observational study designs and experience with Real World Data (Preferred)

Responsibilities

Contributes, attends, and presents at external meetings for Statistics (e.g., Investigators Meetings, Regulatory Agencies, Advisory Boards) as applicable
Provides adequate and qualified statistical and methodological (including Real World Evidence) support to EPD, e.g., 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
Briefs the CRO to ensure appropriate conduct of statistical analysis of EPD Clinical Development studies, including review of the statistical analysis plan, participation in Blind Data Reviews, review of study report tables, listings and figures
Approves the lock of the database and requests unblinding of the study for subsequent analysis
Together with the Clinical/Medical team, clarifies and communicates the results and conclusions to ensure correct interpretation by different users
Supports dossier submissions and study publications and answers statistical questions related to the file/study
Writes the strategic and detailed integration plans for integrated analyses of internal compound databases and ensures proper execution
Fully exploits the potential of the data to enhance knowledge of the compound through data integration and data utilization activities (e.g., meta-analyses, data explorations, integrated data analyses)
Manages external study statisticians working on the analysis of EPD clinical trial data and briefs CROs on methodological and statistical deliverables
Reviews statistical literature, attends conferences and courses to ensure high statistical expertise and maintain proficiency
Works with other statisticians to acquire knowledge on new/improved statistical methodology and keeps up to date in relevant statistical expertise and clinical content expertise

Skills

Statistics

Statistical Methodology

Real World Evidence

Clinical Development Plans

Study Protocols

Interventional Studies

Observational Studies

Endpoint Definitions

Regulatory Interactions

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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