Associate Director Biostatistics

Proclinical is currently recruiting for a Senior Manager/Associate Director of Biostatistics for a pharmaceutical company located in Princeton, NJ. Successful candidate will be responsible for all statistical activities of assigned clinical projects, lead the statistical team and act as point-of-contact on statistical activities of clinical development team.

Job Responsibilities:

• Act as the lead of the statistical team for assigned project or study to manage and coordinate all statistical activities.
• Collaborate with global project team and provides statistical input and guidance to the clinical development plan.
• Collaborate with clinical study team on protocol development including study design, endpoint selection, and power and sample size assessment.
• Authorize the statistical analysis plan and manages the implementation of planned analysis
• Collaborate effectively with internal/external functional teams to ensure high quality deliverables and maintains efficient communication with all parties within the global team.
• Establish and manage the partnership with Biostatistics vendors including the vendor evaluation, selection, and monitoring of statistical activities performed by vendors.
• Lead the development of company Biostatistics standard processes including protocol development, statistical analysis plan development, multiple standard templates etc., and participates in the development of statistical programming/Data Management standard processes, to improve quality, efficiency and effectiveness of Biostatistics deliverables.
• Participate in quality assurance activities and coordinates resolution of audit findings.
• Ensure adherence to company SOPs, GCP, ICH guidelines and all applicable local and international regulations.

Skills and Requirements:

• PhD in Statistics, Biostatistics or Mathematics with 5+ years or MS with 8+ years' experience in a pharmaceutical, biotechnology, CRO or related environment.
• Knowledge of advanced statistical methodologies and innovative clinical trial designs and experience in research on innovative statistical methodology for clinical trial design and analysis to support a new drug development.
• Broad knowledge in multiple therapeutic areas, such as oncology and CNS.
• Broad knowledge of multiple functional areas within the clinical development team including but not limited to clinical operations, data management, statistical programming, medical writing and regulatory affairs.
• Prior experience in early phase development especially in bioequivalence Phase I study design and execution, experience in biosimilar drug development, and experience in NDA/BLA submissions and responding to regulatory agencies (e.g. FDA/MAA/PMDA) requests are preferable.
• Ability to work independently to identify and solve complex problems with minimal supervision.
• Strong analytical, organizational, and project management skills.
• Strong written/oral communications and interpersonal skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Junis Citozi at (+1) 929-388-1650 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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