Abbott zoekt een

Principal Statistician

Weesp, Netherlands

JOB DESCRIPTION:

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.

We currently looking for a Principal Statistician to join our Global Biometrics and Data Center Department.

Primary Job Function:

Coordinates, provides and delivers methodological and statistical expertise and/or statistical analyses for clinical studies in EPD. In this matter supports both the Clinical Development portfolio as well as Strategic Medical Affairs in their support to Affiliates, thereby complying with international, regulatory guidelines and EPD policies and standards. Directs the operational aspects of statistical work as outsourced to CROs.

Core Job Responsibilities:

  • Will drive statistical topics as assigned by Head Biometrics to further the knowledge and impact of applied statistics to clinical development and marketed products support.

  • Will function as lead statistician for several areas, including vaccins and biosimilars, from development plan to study designs, submissions and data exploration.

  • Provides adequate and qualified statistical and methodological support to EPD, eg input into Clinical Development Plans, and study protocols. Responsible for appropriate statistical methodology and endpoint definitions as part of the design of clinical studies and for the associated sample size considerations, including calculations and references. Writes and/or reviews the statistical part of the protocol.

  • 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 Clinician, 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 questions related to the file.

  • For purpose of integrated analyses of internal compound data bases that are accumulating, incumbent writes the strategic and more detailed integration plans in co-operation with Clinical 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).

  • 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.

Position Accountability/Scope:

  • Accountable for statistical design (including sample size justification), analysis and reporting of EPD clinical studies

  • Accountable for statistical review of Affiliate study protocols

  • Accountable for providing statistical support for development and/or product strategies

Minimum Education/Experience:

  • MSc. / PhD in Statistics, or Biostatistics, or a related field.

  • Demonstrated high competence in experimental design and statistical inference. Thorough understanding of International Conference on Harmonization (ICH) Guideline and relevant regulatory requirements (e.g., EU, US, or China). Minimum 7 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.

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:

  • Working at the #1 Top Employer in the Netherlands (for three consecutive years);

  • Career development with an international company where you can grow the career you dream of;

  • 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 the best place to work for diversity, working mothers, female executives and scientists;

  • Excellent employment conditions that you can arrange yourself;

  • A budget that you can use to follow non-work-related training and courses that contribute to your personal development;

  • A sports allowance for work on your fitness;

  • Personal financial planning advice to map out your current financial situation.

How to apply?

If you are appealed by Abbott, looking for a job with meaning, and recognize yourself in the outlined profile, please make your interest known. You can apply via our website (https://www.jobs.abbott/) with your resume and letter of application. Please let me know if you have any questions or comments referring this job profile to Niels Dijkstra, recruitment.netherlands@abbott.com

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:

Netherlands > Weesp : WHS 02

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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