Gerente Estatístico Divisão De Farmacêuticos Estabelecidos (Epd) São Paulosp

Abbott; São Paulo; Presencial; BRL 300.000 - 400.000; Tempo integral

Resumo da oferta

A global healthcare leader in São Paulo is searching for a Statistics Manager to manage projects and provide statistical support for clinical development. The ideal candidate will have a degree in Statistics or Biostatistics and at least 5 years of experience in the pharmaceutical industry. This role involves collaboration with stakeholders and managing external statisticians, ensuring high statistical expertise and compliance with regulations. Competitive benefits and opportunities for growth are provided.

Serviços

Medical and Dental Assistance

Life Insurance

Private Pension Plan

Medication Subsidy

Discount on Abbott stock purchases

Qualificações

• Minimum 5 years experience as Statistician in pharmaceutical industry or CRO.
• Able to explain statistics to non-statisticians.
• Demonstrated competence in experimental design and statistical inference.

Responsabilidades

• Manage several projects in more than one therapeutic area.
• Provide statistical support to clinical development plans.
• Review statistical analysis plans and study report tables.

Conhecimentos

Internship

Accounts Receivable

Generator

Computer Operating

Corporate Risk Management

Formação académica

Graduated in Statistics or Biostatistics or a related field

Descrição da oferta de emprego

JOB DESCRIPTION : About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples 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 your family, be your true self and live a full life. You will have access to :

• Medical and Dental Assistance
• Life Insurance
• Private Pension Plan
• Medication Subsidy
• Discount on Abbott stock purchases
• and 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 work in more than one therapeutic area.

What You’ll Do

Contributes to 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 – 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.

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 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 CROs on methodological and statistical deliverables.

Reviews statistical literature and attends conferences and courses 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.

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.

Key Skills

• Internship
• Accounts Receivable
• Generator
• Computer Operating
• Corporate Risk Management

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

Employment Type: Full-Time

Experience: years

Vacancy: 1