Job Category: Clinical & Statistics

Associate Director/Director, Biostatistician

Job Location: NJ

Small biotech company, New Jersey


Reports to Executive Director, Biostatistics and Data Management

Excellent base salary plus 25% bonus and stock


The Associate Director of Biostatistics works primarily as a lead statistician on project teams to provided and coordinate biostatistics, data management, and statistical programming (BDM) support to specific clinical studies and clinical development programs. Responsibilities include contributing to development plans, setting BDM timeline, managing BDM activities and deliverables, as well as carrying out hands-on work as a project statistician.


Qualifications:

Master’s degree in statistics or related fields required, Ph.D. preferred. Minimum 7-10 years experience in biopharmaceutical clinical development, including hands-on experience in oncology trials and extensive experience in CRO management. Up to date knowledge of oncology research standards, data analysis methods, as well as data presentation and visualization techniques. Strong SAS programming skills. In depth knowledge of overall clinical development process and regulatory requirements. Knowledge in US and European regulations, guidelines, directives and policies relevant to statistics, data processing, database standards and data protection. Effective oral and written communication skills. Teamwork and interpersonal skills. Well-rounded experience in managing CROs as well as various hands-on biostatistics tasks such as contributing the clinical development plans and individual study designs, authoring protocol statistics sections, authoring
eviewing statistical analysis plan (SAP) and clinical trial report statistical methods sections, performing various statistical analysis, validating results, providing appropriate statistical interpretation of results, ensuring compliance of various statistics deliverables. NDA/BLA submission experience preferred.


Duties and responsibilities/Job content:

Manage BDM tasks and oversee CRO BDM activities of assigned clinical development programs and clinical studies with minimal supervision. Contribute to clinical development strategies and plans from statistical and BDM operational perspectives. Interact with team members in other functional areas and represent BDM in team discussions. Ensure the quality and timeline of BDM deliverables. Lead statistical aspects of liaison with regulatory agencies. Work with data management to prepare for study start-up. Work with statistical programming to set up, generate, and QC analysis/submission databases, tables, figures and listings. Carry out hands-on work associated with clinical studies and regulatory submissions, such as authoring protocol statistics sections, authoring
eviewing SAP and clinical trial report statistical methods sections, performing various statistical analysis, providing appropriate statistical interpretation of results, compiling integrated summaries, and QC key data derivations and analyses, ensuring compliance of various statistics deliverables etc, as a project statistician.


Please contact Darren Gutowski at dgutowski@clarkdavis.com


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