Biostatistician - Early Phase
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.
The purpose of this mission is to ensure full biostatistical support to clinical trials in the early phase of the clinical development.
The mission is to provide a biostatistical contribution to the implementation and follow-up of clinical trials in collaboration with the project statistician and the clinical trial team so that the design and statistical analyses meet the primary, and secondary and further objectives of the study while respecting the timelines, quality, regulatory requirements and sponsor’s guidelines.
Your responsibilities will include:
- 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) with the most appropriate methodology and data presentation. Generate a list of statistical output/appendices for the study.
- 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).
- Master degree or PhD in (Bio-)Statistics, (Bio-)Mathematics or comparable qualification;
- At least 5 years of work experience in a pharma, biotech, a cro company or similar;
- Profound knowlege of clinical trials, experience in early clinical development is a strong advantage.
- Some experience in working in global cross functional environment with very good communication skills in English. French/Dutch are plus but not necessary.
- Good SAS Skills, knowing the programming language R is an advantage but not necessary.