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Job Details

Principal Biostatistician (Remote)

Company: Chiltern
Location: Home-Based anywhere in North America (Remote)
Reference: CA_9
Closing Date: 13 Jan 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern is seeking a Principal Biostatistician to work home-based anywhere in North America (Remote). Plan, analyze and summarize the results of individual clinical studies or groups of studies (integrated summaries) and coordinate the development and review of regulatory submissions (e.g., NDAs). Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Chiltern and/or sponsor SOPs or study specific guidelines.

Requirements:

Job Background

Home-Based anywhere in North America

Plan, analyze and summarize the results of individual clinical studies or groups of studies (integrated summaries) and coordinate the development and review of regulatory submissions (e.g., NDAs). Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines. Manage and/or mentor junior level biostatistics staff.

 

  • Apply knowledge of basic and complex statistical design, analysis, and programming techniques.
  • Efficiently and effectively coordinate statistical activities for multiple projects simultaneously.
  • Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies.
  • Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations.
  • Develop and execute study designs and regulatory strategy as related to drug development.
  • Maintain a professional working relationship with sponsors, collaborating associates, and vendors.
  • Represent department and company in a multi-disciplinary setting, including project team meetings and client meetings/presentations.
  • Effective oral and written communication of statistical concepts and results.
  • Assist in the development and review of statistical analysis plans based on study specific documents and sound statistical methodology.
  • Assist in developing, maintaining, and producing statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
  • Ensure the quality and integrity of data analysis and reporting.
  • Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate.
  • Actively monitor project budgets and help staff identify resource or scope of work changes.
  • Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management.
  • Attend related continuing education programs, professional meetings, and other career development activities sponsored.
  • Perform all other related duties as assigned.

Skills:

  • Master’s degree, equivalent, or higher in Biostatistics or related field.  Ph.D. with at least 1-2 years of experience or Master’s degree with at least 3-4 years of experience in CRO and/or Pharma. CRO preferred.
  • Extensive experience in statistical design and analysis methodology or basic and complex studies.
  • Extensive experience in leading statistical activities in clinical research.
  • Experience with regulatory submissions and support preferred.
  • Ability to program in one or more statistical software packages (SAS® preferred) used to conduct statistical analyses.
  • Excellent verbal and written communication.
  • Proven ability to effectively communicate statistical concepts.

KEY ATTRIBUTES:

  • Previous experience in a pharmaceutical research or CRO setting required.
  • Some supervisory experience preferred.
  • Exhibited a positive attitude and willingness to learn and lead in a team setting.
  • A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.

 

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

On Application

Position Type

Permanent
Full Time

Contact

Email Rany Wu - rany.wu@chiltern.com
917 836 3527

Apply for this job: Principal Biostatistician (Remote)

Contact Information:

Address:  Pennsylvania, USA
1016 W 9th Ave, King of Prussia, United States
PA 19406
USA
Website:  Visit Our Web Site

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