We are looking for Experienced Biostatisticians to provide personnel and project oversight to the Biostatistics department for a biopharmaceutical company dedicated to discovering first-in-class therapeutics that address unmet medical needs and improve the health of patients.
You will work with the clinical team in designing clinical studies, writing the statistical analysis plans, conducting the statistical analyses, and providing statistical support for the clinical study reports and scientific presentations.
Duties and Responsibilities include (but are not limited to):
• Line management and supervision of staff, including: performance management, training, mentoring and professional development, in accordance with company policies.
• Ensure accuracy, quality and timeliness of Biostatistics deliverables.
• Participate in the review, update and implementation of processes impacting Biostatistics.
• Perform Senior review of protocols, analysis plans, analysis outputs and other major deliverables.
• Document specific requirements (e.g. systems, training records, SOPs), and remain highly visible in the scientific community through presentation and publication
• Provide statistics programming support for NDA/BLA e-submission activities
• Review or create analysis plan and conduct analysis for ISS/ISE
• Responsible for statistical sections of protocols, clinical study reports, and statistical analysis plns for all active development studies
• Review CRF, database and dataset structure; supervise external statisticians at CROs in statistical analysis plans and final analysis results for clinical studies
• Participate in vendor audits
• Perform validation to ensure all statistical deliverables from CROs meet quality standards
• Review protocols, statistical analysis plans and clinical study reports
• Work closely with Medical Monitor(s) to review SAP for logic, consistency and medical appropriateness
• Ensures cross-study consistency in design and analysis for Clinical Development Plans
• Provide statistical input and guidance on project topics and issues in clinical and regulatory electronic submissions on CDISC data standards
• A PhD in Statistics, Biostatistics or related discipline with a minimum of 3 years of experience in a regulated clinical research environment (pharmaceutical/biotechnology/CRO) is required.
• Or a Master's in Statistics with a minimum of 7 years of clinical research experience in the pharmaceutical or CRO industry.
• Must have a minimum of 3 years experience in designing studies and analyzing data for clinical trials and or early phase clinical trial.
• Excellent understanding of clinical research, the drug development process and requirements on regulatory submissions and compliance.
• Excellent verbal and written communication skills, including presentation skills, are required.
• Excellent analytical skills and knowledge of statistical methodology including experience with modeling and simulations are required.
• Must be familiar with ICH guidelines, regulatory requirements (FDA, eCTD) and industry standards.
• Ability to review and understand data from multiple sources.
• Ability to work effectively in an environment with changing and competing priorities.