Early phase Statistician (M/F)

AIXIAL GROUP; Île-de-France; Sur place; EUR 51 000 - 60 000; Plein temps

Résumé du poste

Aixial Group is seeking an Early Phase Statistician (M/F) to shape statistical strategies for early clinical trials in a dynamic, international setting. The role emphasizes collaboration with clinical teams, design and analysis, and the development of innovative methods in regulated environments.

Candidates should hold a Master’s degree in statistics and have at least five years of experience in clinical statistics, preferably in early phases, within CROs or the pharmaceutical industry.

Qualifications

• Master’s degree in statistics or related field.
• Minimum 5 years of clinical statistics experience, preferably in early phases.
• Experience in CRO or pharmaceutical industry is required.

Responsabilités

• Define statistical objectives for early-phase trials (proof of concept, dose-finding, safety).
• Perform sample size calculations or simulations using East/SAS/R scripts.
• Write statistical sections of protocols, SAPs, and study reports; conduct analyses.

Connaissances

Clinical statistics

Early phase trials

SAS

R

Bayesian methods

Formation

Master's degree in statistics

Outils

SAS

R

East

Description du poste

Are you passionate about Life Sciences and Clinical Research?

Do you want to thrive in a dynamic, collaborative, and international environment where your expertise directly impacts the lives of millions?

Join Aixial Group and help shape the future of clinical research!

Aixial Group is looking for its next Early Phase Statistician (M/F).

Here’s an overview of the key responsibilities (non-exhaustive list) that Aixial Group offers:

Collaboration with Clinical/Medical Teams

• Define statistical objectives for early-phase trials (proof of concept, dose-finding, safety).

Statistical Design and Analysis

• Perform sample size calculations or simulations (e.g., using East/SAS/R scripts) and draft associated documentation.
• Define evaluation criteria (endpoints) and statistical methods.
• Write statistical sections of protocols, Statistical Analysis Plans (SAPs), and study reports.
• Conduct exploratory/confirmatory analyses (hypothesis testing, PK/PD modeling, subgroup analyses).

Tools and Presentation

• Use software such as SAS and R.
• Present results to project teams and stakeholders.
• Contribute to scientific publications (abstracts, articles).

Methodological Innovation

• Develop and implement cutting-edge statistical methods (e.g., adaptive designs, Bayesian analyses).
• Propose creative solutions to optimize trial design.

Required Profile

Education and Experience

• Education: Master’s degree (or equivalent) in statistics, biostatistics, epidemiology, computer science, or a related scientific field.
• Experience: Minimum 5 years in clinical statistics (preferably in early phases) within a CRO or the pharmaceutical industry.

Technical Skills

• Software: Advanced proficiency in SAS and R.
• Industry Context:
• Proven experience in interventional clinical trials (early phases: proof of concept, dose-finding, safety).
• Regulations: Knowledge of ICH-GCP, ICH-E9, and regulatory expectations.

Innovation and Methodology

• Experience with innovative methods: adaptive designs, Bayesian analyses, etc.
• Innovative mindset: Curiosity for novel approaches in a regulated environment.

Language and Soft Skills

• Languages:
• French: Fluent.
• English: Proficient (B2 minimum for interactions with international authorities).
• Soft Skills: Teamwork, rigor, ability to simplify complex concepts.

Conditions and benefits

Position based in Europe

Compensation based on a range of €51k–€60k

Who Are we?

We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.

We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe providing them with innovative and scalable solutions.

We are operating in 9 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.

We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide.

Why Join Us?

Make a positive impact and be at the forefront of project: You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

Career Development: People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

Our commitment to Diversity, Equality, and Inclusion: We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. Gender equality is at the core of the development strategy of Aixial Group.

Aixial Group continues to grow, and to recruit in the clinical trial professions. Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/

For more information: https://www.linkedin.com/company/aixialgroup/about/