Phone, Email, Postal Address:
# of Openings: 1
The Senior Biostatistician will manage aspects of biostatistics supporting drug development activities and clinical decision making. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results.
- – Provide expertise and guidance to the Clinical Development team regarding statistical methods for data analysis of clinical trials.
- – Provide statistical representation and leadership on project and protocol teams and to regulatory agencies.
- – Participate in the protocol development process, including responsibility for sample size/ power calculations and the statistical section of the protocol.
- – Responsible for preparation of the Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the clinical study report (CSR) and/or publications.
- – Lead verification of statistical programs, data sets used and statistical results in regulatory documents and other clinical data reports.
- – Participate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publication.
- – Participate in regulatory preparation activities including document authorship (e.g. BLA, sBLA), and answering requests from the FDA.
- – Provide statistical interpretation and explanation of results to team members.
- – Work collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day to day biostatistics deliverables.
- – Contribute to the design, and analysis of clinical studies using appropriate and innovative statistical methods.
- – Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
Pay Rate / Salary: DOE
Skills / Education Requirements:
Ph.D. or M.S. in Statistics or Applied Mathematics or similar required.
- – 4-6 years of experience in clinical development research.
- – Must have expert knowledge and experience in biostatistical theory, analysis and computer science.
- – Experience with regulatory submissions, project and proposal management experience are relevant qualifications for this position. SAS experience is a requirement.
- – Demonstrated ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects.
- – Prior successful BLA and/or NDA filing experience is required.
- – Experience interacting with regulatory agencies, both US and ex-US, desirable.
- – Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
- – Excellent interpersonal and communication skills, both verbal and written.
- – Consummate team player with excellent collaboration skills.
- – Ability to communicate statistical information to non-scientists, and willingness to educate the internal team.
- – Strong customer orientated awareness and focus; strives to support others to succeed.
- – Attention to detail with a focus on quality deliverables.
- – Advanced computer skills including spreadsheets, word processing database management and specialized statistical software packages with an emphasis on strong skills using Statistical Analysis System (SAS) software.
- – Strong leadership skills with the ability to influence decisions and achieve results.
- – Ability to adjust to multiple demands, shifting priorities, and unexpected events while maintaining a positive work attitude.
Date Posted: 10-16-2019