Job Description
Our client, a cutting edge scientifically driven Biotech company with strong development pipeline and multiple blockbuster products, now seeks a who now has a newly created role of Director of Biostatistics based in their Dublin office. This hire will work with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of company clinical data in efficiently achieving regulatory, scientific and business objectives.
The successful candidate will utilize their knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives; collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company.
This hire will work collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
The ideal candidate will be operating in similar role and have proven knowledge of regulatory requirements, with demonstrated experience in ensure the company meets regulatory, scientific, and business objectives.
Key duties of this role:
Oversee and contribute to the completion of all technical and operational statistical activities for clinical development programs for multiple compounds or equivalent through management of internal and external resources.
Negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles.
Provides overall leadership for a departmental strategic initiative.
Has understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company.
Can make effective decisions where information is limited or solutions may produce unpleasant consequences in the short term.
Able to set up and influence collaborations with external academic or government organizations to extend visibility or business need of the company.
Can set up data monitoring committees for clinical studies.
Able to identify the most critical aspects of a problem/issue.
Can use competitive intelligence to influence clinical development strategies.
Requirements for Director of Biostatistics:
BS degree in Biostatistics or equivalent.
12 years of industry experience in the statistical analysis of biomedical data using SAS® software in pharmaceutical/biotech/CRO industry experience, ideally 3 years of which in a leadership role.
Thorough understanding of the clinical trials design and reporting process and Regulatory reporting requirements (e.g. supporting NDA, BLA and EMEA filings).
Proven ability to directly supervise personnel and lead their department.
Effective verbal and written communication and strong interpersonal skills are required.
Must work well within a dynamic, interdisciplinary,
Dynamic self-starter; agile learner; strategic and creative thinker.
Demonstrated strong problem solving and risk-mitigation skills.
For further details please phone 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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