Director, Clinical Biostatistics (FullTime)

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Summary

This position requires a broad, in-depth knowledge of statistical methodology and experimental design, worldwide regulatory requirements, clinical trial expertise from Phase I to V. As head of biostatistics, the main responsibilities are to:

• Ensure proper development of protocols with respect to analyses of data so that study objectives can be met.
• Ensure the use of established statistical and programming procedures and good practices to collect, organize, analyze, summarize, interpret and report the results of clinical studies. This includes any integration of study reports into summaries for submission to regulatory agencies for drug approval.
• Oversee and review the design/planning of appropriate statistical methodology in conformance with good statistical practices with FDA and ICH guidelines within the therapeutic areas of responsibility for worldwide filings.
• Performs needs assessment of supplemental statistical software and directs the acquisition, validation, implementation, and usage of supplemental statistical software.' Ensures software is compliant with applicable regulations such as 21CFR Part 11.
• Actively participate in departmental leadership and management of consistent processes.
• Identifies and resolves resource and timeline issues, and set priorities within the functional group.
• Develops and maintains departmental Standard Operating Procedures (SOPs) for biostatistical function and oversee employee training, and associated requirements.
• Procures and oversees outside vendors and consultants as required.
• Actively works to promote team building and morale within the function/department.
• Depending on experience level, this could be an Associate Director, Director, of Sr. Director position.

Qualifications

• A PhD in Biostatistics/Statistics with at least 10 years of experience in Pharmaceutical R&D.;
• Extensive experience supporting regulatory submissions is required.
• Supervisory experience preferred; experience with project development preferred.
• Knowledge of mainstream statistical packages like SAS is required.
• Knowledge of SQL, relational databases and of issues relating to security and integrity of data desirable.
  
  Technical Skills:
  
  
• Direct experience in study development and clinical development planning, especially the ability to make contributions to statistical sections
• Direct experience in study development and clinical development planning, especially the ability to make contributions to statistical sections
• Direct experience in analysis planning and productions starting from CRF development, ending with the combining of study data for Integrated Summary of Safety and Integrated Summary of Efficacy for a submission.
• Knowledge of statistical techniques appropriate to all Phases (I-IV) of clinical trials, including but not limited to these techniques for both categorical or continuous data: large sample, non parametric (ranks) group sequential, multiple comparisons and censored data. To a lesser extent, these techniques: exact inference, Bayesian longitudinal
• Excellent written and oral communication skills.
• Solid understanding of clinical drug development process
• Good computer skills (MS Office products, word processing, spreadsheets, internet, e-mail).
• Experience developing budgets including staffing requirements, equipment needs and space needs
  
  Conceptual Skills:
  
  
• High attention to detail and accuracy and ability to manage multiple project teams.
• Excellent prioritization and organizational skills and demonstrated ability to delegate appropriately
• Ability to work on extremely complex problems where analysis requires evaluating various factors
• Ability to exercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results
  
  Interpersonal Skills:
  
  
• Advanced people management skills and positive flexible outlook.
• Excellent interpersonal communication skills and works effectively on cross-functional teams.
• Ability to mentor and coach others in a positive manner
• Presents professional manner and appearance.