Manager, Statistical Programming

Proclinical is currently seeking a Manager of Statistical Programming for a global specialty pharmaceutical company located in Bedminster, NJ. Successful candidate will be responsible for assigning tasks and assessing the quality of Statistical Programming.

Job Responsibilities

• Training and managing employees and consultants within area of responsibilities.
• Participating in budget and resource planning for clinical trial and ad hoc requests related to the Statistical Programing deliverables.
• Partnering with Clinical Application and Database groups in developing and maintaining infrastructure of the programming environment.
• Establishing and negotiating timelines with internal and external team members for completion of activities for a project.
• Developing, applying, managing and promoting consistent programming standards.
• Maintaining appropriate documentation surrounding retaining or archiving clinical data and/or programs.
• Following regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions.
• Leading the group to design robust, flexible, and modular macros and implementing across various projects.
• Interacting with other functional areas to resolve issues pertaining to duties assigned or requested technical consultation.
• Conducting oversight management of vendors and assessing the quality of clinical trial information provided in support of clinical trial submissions to regulatory authorities.

Skills and Requirements

• BS or BA in Computer Information System, Computer Science, Mathematics, Statistics, or a related field.
• 10 years of SAS programming experience in scientific/research field, 3+ years of experience in supporting regulatory submissions, 3+ years of managing direct employees.
• In-depth knowledge of CDISC SDTM, ADaM, Define.xml, CFR 21 Part 11 compliance, ICH and FDA standards preferred.
• Strong knowledge of BASE/SAS, SAS Macros, ODS and SAS/Graph in a Windows SAS environment.
• Knowledge of the Software Development Life Cycle (SDLC) and methodologies.
• Knowledge of MS-Office.
• Technical writing skills adequate to prepare effective documentation for programs and contribute to SOP development.
• Effective interpersonal skills in collaborating with teams composed of individuals with widely diverse backgrounds, skill levels, and organizational levels.

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 [CONSULTANT NAME] at […] 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.

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