50552Mkp - Lead Statistician Clinical Statistics

This offer is part of the Biomedicine and Health Talent Marketplace organized by Barcelona Activa in collaboration with CATALONIA.HEALTH during the Connection Day. BAYER SL is looking for the profile Lead Statistician Clinical Statistics.

Only people who meet the profile requested by the company will be notified.

The pre-selected people will receive an email from Barcelona Activa with the confirmation of attendance and organizational details.

Once pre-selected, your availability for the Job Marketplace will be requested : Tuesday April 29th, from 15h to 18h.

• Location to be determined.

FUNCTIONS AND TASKS :

BAYER facilitates a varied and meaningful career in a community of bright and diverse minds to make a real difference. Mission Bayer SL “Health for all, Hunger for none”, we deliver breakthrough innovations in healthcare and agriculture.

A Lead Statistician builds and leads teams of statisticians and representatives from other functions and ensures the use of appropriate and efficient statistical analysis methods during development, submission, and / or life-cycle management of Bayer products according to applicable global and regional standards, procedures, and regulatory guidelines and represents projects to line management and governance boards.

Major tasks and responsibilities :

• Takes the statistical lead for a project in the represented Statistics Sub-Cluster, for example, in the role of a Project Statistician.
• Leads virtual teams of statisticians and / or representatives from other functions.
• Contributes to the development and evolution of project standards.
• Provides statistical and methodological consultation and contributes to multi-disciplinary teams within or across companies.
• Responds to inquiries from health authorities and other internal or external partners.
• Keeps abreast of regulatory and methodological issues and ensures implementation of these in the respective teams.
• Influences decision making processes during drug development and / or life-cycle management by use of appropriate statistical methodology (e.g., simulations, meta-analyses, or modeling approaches).
• Develops and implements innovative statistical methodology for the respective field of responsibility, if appropriate in cooperation with academic experts.

Value Added :

• Statistics and statistical methodology are an integral part of drug development and life-cycle management impacting the planning, design, analysis, and reporting of studies, projects, and programs in order to achieve regulatory approval, scientific acceptance as well as successful product launch and maintenance.
• The Lead Statistician contributes to drug research, the development of new drugs, the approval of new drugs by health and reimbursement authorities, and the life-cycle management of marketed drugs according to the major tasks and responsibilities of the position.
• The Lead Statistician facilitates risk management decisions within the company through the development and implementation of innovative statistical methodology.

Work relations :

• Early Clinical Leaders / Global Clinical Leaders
• Global Safety Leaders
• Statisticians and Statistical Analysts
• Study Team Members and / or Clinical Team Members
• Global Regulatory Strategist
• External Experts in Statistical methodology, providers of statistical specialist software, and CROs providing statistical expertise

OFFER YOU :

Work-life balance for your physical & mental wellbeing.

Competitive salaries & financial wellbeing (e.g., life insurance).

Promote employee's well-being, Inclusion & diversity, and sustainability in a collaborative and innovative environment.

Social engagement through our volunteering program.

• Type of contract : Permanent

Number of hours per week : 40h.

Schedule : 9h to 18h. Hybrid.

Gross annual remuneration : Within the Offices and Offices Agreement. According to interview.

Requisites : Qualifications :

PhD or MS in Biostatistics, Statistics, or Mathematics - At least four years of experience as a statistician with significant time spent in the Pharma, Biotech, or similar sector - Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and / or life-cycle management and associated documents and regulations - Experience in leading teams - Embrace and role model the VACC (Visionary / Architect / Catalyst / Coach) behaviors in leadership, as well as mentoring / coaching capabilities across diverse cultural environments, in a DSO (Dynamic Shared Ownership) environment - Experience in multiple fields relevant for his / her statistics sub-function - Excellent interpersonal, leadership, and communication skills and ability to work independently and collaboratively - Good knowledge of statistical programming languages (including SAS and / or R) - Fluency in English.

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