Biostatistics, Associate Director
|Contact Name:||Larry O’Leary|
Our client, a cutting edge scientifically driven Biotech company with commercial product and strong development pipeline, now seeks a Biostatistics Associate Director for their Biostatistics function operating within Clinical Development, in their Dublin office.
The successful candidate the Biostatistics, Associate Director will provide statistical leadership and technical expertise in support of clinical development and some post-marketing activities for multiple therapeutic areas. In collaboration with the head of Biometrics and other project statisticians so that activities are aligned with company goals; standards and processes are consistent across all therapeutic areas.
This hire will work build partnership with stakeholders within Clinical Development; participate in and support the design, planning and execution of Clinical Development activities such as protocol, statistical analysis plan, reporting and interpretation of clinical study results, and regulatory interactions.
The ideal candidate will have advanced qualifications in Biostatistics / Statistics and operating in similar role within Pharma / Biopharma industry; therefore having proven knowledge of regulatory requirements ensuring the company meets regulatory, scientific, and business objectives.
Key duties of this role:
Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches), support and defend statistical analyses and their interpretations in regulatory agency interactions; author statistical contributions to clinical study reports, regulatory briefing documents and NDA submissions.
Actively participate in project teams as the Biostatistics lead. Interacts strategically with cross-functional teams and other functional areas to ensure timely project deliverables.
Maintains consistently high-performance standards and quality of work and ensures all clinical development programs meet scientific, regulatory, quality and commercialization requirements.
Provide statistical expertise in the clinical development and lifecycle management activities for all assigned products.
Plans, directs and organizes all statistical activities for the assigned products including study protocol development, statistical methodology, data analysis and interpretation, and ensures clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products.
Lead in development and adaptation of new statistical methodology in support of company drug development.
Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations.
Manage outside statistical CROs and consultants, as needed, maintaining a constant and open communication to make sure timely and quality deliverables.
BS degree in Life Science with advanced qualifications in Biostatistics or equivalent. MSc or PhD in statistics or biostatistics is preferred.
8+ years of Statistical / Biostatistical clinical development experience in the pharmaceutical/biotech industry.
Experience with regulatory interactions (FDA and/or EMA).Solid understanding of clinical trial principles and regulatory requirements.
Knowledge of industry data standards.
Proficiency with statistical analysis software such as SAS and/or R.
Effective verbal and written communication and strong interpersonal skills.
Demonstrated ability to work in a team environment
Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.
Dynamic self-starter; agile learner; strategic and creative thinker.
Proven ability to work under minimal supervision.
Demonstrated strong problem solving and risk-mitigation skills.
For further details please phone Larry on +353 1-2302400 / firstname.lastname@example.org
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
Follow us on: Facebook, Linked-in, twitter