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Senior Director, Biostatistics & Statistical Programming

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POST DATE 8/24/2016
END DATE 10/18/2016

Chiltern Wilmington, NC

Company
Chiltern
Job Classification
Full Time
Company Ref #
TL-4958
AJE Ref #
575970098
Location
Wilmington, NC
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Masters Degree

JOB DESCRIPTION

APPLY
SENIOR DIRECTOR, BIOSTATISTICS & STATISTICAL PROGRAMMING

JOB REFERENCE

TL-4958

JOB BACKGROUND

We are seeking a Sr. Director, Biostatistics & Statistical Programming to join our team! Direct the activities of Biostatistics and Statistical Programming staff including statistical consulting, statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other regulatory submissions. Provide daily supervision of Biostatistics operations and personnel. 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. Develop business development strategy for marketing of department and generating new business opportunities.

This position can be office-based or home-based.

DUTIES & RESPONSIBILITIES



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

REQUIREMENTS



1. Master s degree, equivalent, or higher in Biostatistics or related field
2. Minimum 10 + years of line management experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
3. Extensive experience in statistical design and analysis methodology or basic and complex studies
4. Extensive experience in leading statistical activities in clinical research
5. Experience with regulatory submissions and support
6. Significant previous experience in a pharmaceutical research or CRO setting required
7. Extensive knowledge of the drug development process and FDA and ICH Guidelines
8. Ability to program in one or more statistical software packages (SAS preferred) used to conduct statistical analyses
9. Excellent verbal and written communication
10. Proven ability to effectively communicate statistical concepts
11. Proven ability to manage groups across multiple locations, offices, and/or countries, as appropriate

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

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 Timica Lindsey
+1 919 468 2282