Consultor Sap Pp

buscojobs España; Lyon; À distance; EUR 60 000 - 90 000; Plein temps

Résumé du poste

A leading CRO is seeking a Principal Biostatistician to lead biostatistics and programming activities for clinical studies. The role demands a strong background in statistics and the ability to manage complex programs while ensuring quality and compliance. Candidates can expect a flexible work environment and a commitment to professional development.

Prestations

Flexible working platforms

Excellent employment package and benefits

Qualifications

• Strong experience in biostatistics or related field, particularly in clinical trials.
• Proven track record of leading biostatistics activities for complex programs.
• In-depth knowledge of clinical trials methodology and regulatory requirements.

Responsabilités

• Leading Biostatistics and Programming activities for programs.
• Providing strategic oversight and ensuring compliance with regulatory standards.
• Conducting statistical analysis and reporting results.

Connaissances

Communication

Leadership

Collaboration

Formation

M.S. or Ph.D. degree in statistics or biostatistics

Outils

SAS

Description du poste

Senior or Principal Biostatistician – Leading CRO – Homebased – Spain

We have recently partnered with an award winning CRO, who are looking for an experienced Principal Statistician (or Senior looking to move into Principal), to join their successful study delivery team, any area of specialism considered.

How You Will Be a Success :

As a Principal Biostatistician, you will be accountable for :

• Leading Biostatistics and Programming activities for a program of studies with moderate complexity and / or high value and impact for the organization.
• Planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies.
• Ensuring the timely, budget-compliant delivery of individual studies and integrated analyses to the required quality standards.
• Maintaining consistency across studies within the program.
• Providing strategic oversight and direction, with a focus on optimal resource allocation and effective team performance.
• Leveraging your regulatory interaction experience to ensure compliance with regulatory standards and contribute to submissions and responses to regulatory inquiries.
• Providing biostatistical input into the design of clinical programs, including protocol input such as study design, sample size calculations, and patient randomization schemes.
• Contributing to statistical aspects of case report form (CRF) design.
• Reviewing project database structures, edit checks, and data management coding conventions.
• Preparing statistical analysis plans (SAP), defining derived data, and designing statistical tables, figures, and data listings for clinical summary reports.
• Conducting statistical analysis, interpreting data, and reporting results.
• Writing and reviewing statistical methods sections of integrated study reports.
• Supporting responses to regulatory questions on program design, labelling claims, and regulatory submissions.
• Participating in presentations at client and investigator meetings.
• Preparing biostatistics input for research proposals, defending proposals, and presenting at marketing meetings with prospective clients.

Key Qualifications and Skills :

• M.S. or Ph.D. degree in statistics, biostatistics, or a related field.
• Strong experience in biostatistics or a related field, particularly in clinical trials and statistical analysis.
• Proven track record of leading Biostatistics and Programming activities for complex, high-value programs.
• Excellent leadership, coaching, and mentorship skills.
• In-depth knowledge of clinical trials methodology, regulatory requirements, and statistical software packages (e.g., SAS).
• Strong communication and collaboration skills, with the ability to present complex data and analysis to diverse stakeholders.

What you get in return

Ongoing development is vital, and as a Principal Biostatistician you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. In comparison with their competitor’s and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry.

They also provide successful candidates with an excellent employment package and benefits adapted to the current job market. The company like to look at themselves more like an extended family with consideration of staff as individuals allowing a work-life balance.

Company culture :

This is a company where their people set them apart. Diverse teams enable them to become a better partner to their customers and help to fulfil our mission to advance and improve patients’ lives.

The company have an ‘Own It’ culture, driven by four key values that bring them together as individuals and set them apart as an organisation : Accountability & Delivery, Collaboration, Partnership and Integrity. It is key to be a CRO that delivers excellence to their clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.

What to do next : If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.

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