AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.
We are currently looking for an Biostatistician to ensure full biostatistical support to clinical trials in the early phase of the clinical development and manage relevant activities and related issues that may arise, i. e. :
- Provide statistical input to all relevant tasks for early phase clinical trials.
- Establish the sample size for the study, or even develop simulation programs to evaluate the operational characteristics of a trial.
- Collaborate with the team on how to collect and derive data.
- Review and contribute to study documents: in particular Case Report Form (CRF), Central Monitoring Plan (CMP), Study Risk Management Plan, interactive randomization tool (IRT) specifications.
- Determine the randomization plan and ensure that it is implemented correctly by the IRT.
- Provide statistical expertise in data review.
- Write a precise, clear, and complete statistical analysis plan (SAP)
- Provide programming instructions to the statistical programmers, validation of the SDTM/ADAM documentation (mainly derived variables).
- Prepare, check, and approve the statistical analysis programs.
- Communicate, discuss, and interpret statistical results, including co-authoring the clinical study report.
- Participation in submission activities.
- Participation in team meetings.
- Ensure that all activities under their responsibility are properly documented (traceability of changes, data specifications) according to sponsor’s procedures.
- Work in accordance with ICH GCP, other international guidelines (e.g. ISO), working group recommendations (e.g. CDISC or Good Programming Practices).
- MSc. or PhD. in (Bio)Statistics, (Bio)Mathematics
- At least 5 years of exp. for pharma, biotech or CRO company
- Knowledge of Clinical Trials (exp. in early clinical development is a plus)
- Experience in international environment
- Fluency in English (French or Dutch is plus)
- Experience with SAS and R