Clinical Statistician (m/F)

mardi 13 mars 2018
Date limite
vendredi 13 avril 2018
Carine Steurs
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Clinical Statistician (m/F) Organisation description:

Within the Biostatistics & Data Management team, biostatisticians provide statistical expertise and support in the development of prophylactic or therapeutic vaccines.

Amongst the 90 statisticians part of an international team and devoted to the discovery and development of vaccines, an expanding team of about 10 statisticians/statistical programmers are providing statistical expertise to the cancer immunotherapeutics clinical development. Currently two Phase III studies are ongoing in non-small cell lung cancer and melanoma;

It's a growing team sharing and learning from each other. Creative, always looking for new and better ways to do their job. They focus on performance but recognize there is no achievement without integrity.

Job description:

As senior biostatistician in the oncology statistical team, you will :

Participate in the cancer immunotherapeutics development plan (trial designs, sample sizes, interim analysis, etc.) in collaboration with clinical development managers and safety physicians.

In particular, provide strategic, statistical, and scientific input into clinical development planning

Be responsible for the statistical designs of clinical trials, creating statistical sections for study synopses and protocols

Give your input in study set up (case report forms, database, randomization)

Explore new statistical approaches and methodologies through innovative and creative thinking

Interact with regulatory authorities

Propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans

Perform statistical analysis, run simulations and discuss with internal and external experts

Support scientific writers and clinicians to correctly interpret the statistical results and align them with the clinical report conclusions

Write the statistical sections of clinical study reports, statistical publications and prepare materials for publications and create statistical text for clinical study communication


You have:

A M.Sc. or Ph.D. degree in Biostatistics

At least 5-7 years of experience in Statistics

Good knowledge of statistical approaches applied in cancer clinical trials with a focus on survival analysis techniques

Comprehensive understanding of applied statistical principles and modeling in the design and analysis of clinical trials

Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis

You're also:

Able to easily communicate with different functions: clinicians, scientists, data

managers, scientific writers, commercials, etc. in an international, multi-cultural


Compliant with internal Standard Operating Procedures and regulatory guidelines

Proficient in SAS or other statistical software is an asset

Fluent in French and in English


We offer you a permanent contract with XPE Pharma as Consultant, a job in a Great place to work

XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713

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