For the expansion of our client's clinical team, we are looking for a Senior Biostatistician.
The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Their unique antibody engineering technologies combined with the complementary expertise of their people enables them to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
The Senior Biostatistician executes diverse statistical tasks supporting the company's clinical development programs. The tasks mainly focus on managing the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR.
The senior Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:
- Serves as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
- Contributes to clinical study synopses and protocols.
- Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
- Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
- Provides relevant input in the development and review of CRFs.
- Performs lead review and sets up internal QC of TFLs.
- Performs critical review of derived datasets specifications and derived datasets (ADaM).
- Contributes to clinical study reports.
- Reviews simple to complex randomization specifications and dummy randomization schemes.
- Participates in bid defense meetings.
- Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
- Contributes to press releases and scientific papers.
- Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
- Fluent with other statistical software such as R, EAST, Winbugs is a plus.
- Thorough knowledge of and experience with CDISC standards is desired.
- Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
- Displays excellent communication skills with demonstrated leadership ability.
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
- Master’s degree in statistics or biostatistics required.
- Minimum of 6-8 years of biostatistical experience desired.
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or oncology clinical study background is a plus
- An attractive salary in line with your experience and skills.
- Fringe benefits including medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.