This individual will provide statistical expertise to support the clinical development of a hemophilia program. Candidate will provide critical input on the design and analysis of our clinical trial data so that accurate assessments are made for decision-making.
This individual will have to use his/her technical expertise to make the appropriate decision concerning which method to use for analyzing data. He/she will also have to provide a critical review to ensure the correctness of results for accurate decision-making. He/she will have to work in a multidisciplinary team and will have to effectively communicate to team members who may not have the same training.
We operate in a highly regulated environment; therefore, we must ensure that our work is of the highest quality and will withstand the scrutiny of regulatory agencies around the world. This individual must possess the ability to work on several different studies while managing the details is highly important.
Some of the duties of this individual are:
Provide statistical support to other statisticians through the management of tasks at the trial level
With supervision by a more senior statistician or head of Biostatistics, produces synopsis, statistical section of the protocol, and SAP for specific studies
Participates in programming activities (analysis files, TLFs, randomization, …)
With supervision by a more senior statistician or head of Biostatistics, completes the statistical section of the CSR
Reviews and approves study-related documents (CRFs, DEPs, …)
With supervision by a more senior statistician or head of Biostatistics, computes sample sizes, discuss trial design, and creates randomization
In collaboration with the programmers, ensures that statistical programs are developed, tested and validated prior to the target analysis date.
Skills: 3-6 years of relevant experience
Knowledge of SAS programming
Ability to support Phase I - III studies (mainly phase II/III)
Abillity to work on multiple studies at one time
Education: Master's or PhD in a relevant area
Skills and Experience: