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Job Details

Director of Biostatistics (Remote)

Company: Chiltern
Location: Home-Based anywhere in North America (Remote)
Reference: RW_10
Closing Date: 24 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Home-Based anywhere in North America (Remote)

Requirements:

Job Background

Incumbents in line management positions perform a variety of duties related to supervision of Biostatistics staff as well as overall leadership of the department. Ensure departmental goals and deliverables are met. 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.

 

1. Selection, training, development, and performance management for a team of Biostatisticians as well as line managers and Level 1 Directors

2. Efficiently and effectively coordinate statistical activities for multiple projects simultaneously

3. Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations

4. Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management

5. Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel

6. Define achievable goals and tasks as related to a departmental objective or initiative. Identify areas for improvement (e.g. SOPs, processes etc)

7. Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to the other Directors. Actively monitor project budgets and help staff identify resource or scope of work changes

8. Represent department and company in multi-disciplinary settings and meetings, including (but not limited to): project team meetings; client meetings/presentations; bid defense meetings; marketing and new business ventures; contributing to bids & proposals submissions.

9. Perform other responsibilities as required by the Department.

  • Master’s degree, equivalent, or higher in Biostatistics or related field  
  • Advanced degree in Life Sciences, Biostatistics, or
  • Related discipline preferred  
  • Minimum 10 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Incumbents in line management positions must have minimum 6 + years’ line experience
  • with statistical professionals
  • Prior CRO industry experience
  • 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 
  • Proven ability to effectively communicate statistical concepts. The ability to communicate effectively in English.
  • Ability to maintain confidentiality of data and information during
  • interactions with staff at all levels Expertise in relevant drug or device development or specific service disciplines
  • Expertise with the clinical and operational elements of pharmaceutical or Device
  • development 
  • Demonstrated ability to foster strategic, collaborative, relationships with external stake holders
  • Demonstrated ability to establish and maintain credible and influential relationships with external thought leaders in a therapeutic area Previous Clinical Operations experience (design and implementation of clinical trials) Thorough understanding of the principles of ICH GCP and regulatory requirements
  • Working knowledge of MS Office programs

 

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: Director of Biostatistics (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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