Manager, Statistical Programming

Highly Competitive Salary
  1. Permanent
  2. Programming
  3. United States
Bedminster, New Jersey
Posting date: 27 Jun 2019

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:

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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.