Job Description
Our client is an exciting, rapidly growing clinical stage Biotech company focused on delivering a major breakthrough in treatment within a Neuroscience area that has huge unmet needs, having seen no new treatment in decades. Given the increase in their development pipeline and notable progression of several of their clinical studies, we now have approval for a permanent position of Lead Biostatistician.
This global level role will have high visibility within the company and the Neuroscience therapy area, with opportunity to make significant impact on early and late-stage studies, and their progression towards regulatory submission and approvals.
As Lead Biostatistician you will be accountable for providing statistical input to project development plans, trial designs, clinical trial protocols and reports, briefing packages to authorities and to engage in dialogue with regulatory authorities.
This role will provide oversight of outsourced development programs (vendors and other such contractor resources), including oversight of clinical study design, statistical programming, analysis, and reporting of these early and late-stage clinical trials, etc.
The preferred candidate will have a depth of Biostatistics experience in Clinical Development in industry (Pharma / Biotech / CRO); with ideally relevant biostatistics experience in the management of outsourced development programs, with attitude and ability to be effective in a highly ambitious Biotech environment.
Requirements:
PhD in Biostatistics or related field and 3 years relevant Biostatistician experience in industry or
Master's degree in Biostatistics or related field and at least 5 years of Biostatistician experience within clinical development.
Experience in drug development within Neuroscience is preferred.
Comprehensive data analytic expertise based on a good understanding of statistical principles and a strong track record of applied experience leading to successful program support, ideally within CNS research.
Extensive knowledge about design of clinical trial, statistical methodologies, statistical programming, and interpretation and presentation of complex statistical results.
Demonstrates understanding of the disease area and health authority requirements i.e., GCP and ICH guidelines.
Proficient programming skills in statistical software's, such as SAS or R.
Working knowledge of relevant Data Standards (such as CDISC / ADaM).
Excellent oral and written communication skills including ability to communicate statistical problems and ideas clearly to both statistical colleagues and stakeholders from other functional areas.
Experience in the management of outsourced development programs.
Experience in working and influencing cross-functionally.
Excellent attention and accuracy with details.
Exhibits high motivation and high energy level, self-starter.
For further details, please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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