Biostatistician Expert, Biotech
|Job Title:||Biostatistician Expert, Biotech|
|Job Published:||7 months ago|
Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a newly created role of Biostatistician as part of the Clinical Sciences team, working closely with Regulatory Affairs, Medical Affairs, Clinical Operations, CMC, and other functions.
As the Biostatistical expert 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, including oversight of clinical study design, statistical programming, analysis, and reporting of these early and late-stage clinical trials, etc.
The ideal candidate will have a blend of Biostatistician experience in both Pharma and Biotech, with relevant biostatics experience in the management of outsourced development programs, with attitude and ability to be effective in a lean, small company environment.
All statistical aspects of designing, statistical programming, analysing, and reporting of early and late-stage clinical trials - being accountable for all associated biostatistics deliverables during the life-cycle of our clinical development programs.
Supporting the development of clinical study synopses/protocols, sample size calculation, CRF review etc. applying statistical expertise to ensure scientific validity and proper design and execution of clinical trials.
Leading exploratory data analyses to understand the activity of our compounds and support development decisions - collaborate to generate health economics evidence and publications.
Coordinating and supervising outsourced biostatistician, data management and data programming activities - advising on database design, validation checks and critical data.
Leading the generation of the statistical analysis plan (SAP) ensuring consistency and alignment with regulatory guidelines - writing statistical sections of integrated reports.
Coordinate the development table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
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 CNS 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 programmes.
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 / email@example.com
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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