Senior Statistical Programmer

Employer
Rho, Inc.
Location
Research Triangle Park, NC
Posted
Oct 09, 2020
Required Education
Bachelors Degree
Position Type
Full time

Overview

The Sr. Statistical Programmer will convert data from specifications and statements of problems to computer code. The person in this role will consult with sponsors, project leads systems analysts, other programmers, and end users to gather information about program intent, functions, features, data requirements, input requirements, output requirements, internal and external checks and controls, hardware and operating system environment, and interfaces with other systems.

Responsibilities

  • Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users
  • Use expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design
  • Incorporate study protocol and SAP into specifications for conversions to CDSIC
  • Convert designs and specifications into computer code
  • Analyze code to find causes of errors and revise programs
  • Write and maintain documentation of changes to computer code, programs, and specifications
  • Review user and technical documentation written by others to confirm consistency with program operations
  • Revise program for corrections, enhancements, or system environment changes.
  • Coordinate with other programmers or statisticians about program revisions
  • Modify and maintain software programs written by others
  • Provide mentorship and training to peers and more junior programmers in areas of expertise
  • Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management
  • Perform functional lead activities on assigned projects
  • May serve as the Project Lead on assigned projects
  • May provide guidance and input to the budgets and business submissions of proposals

Qualifications

  • BA/BS in computer science, statistics, or related field
  • A minimum of 5 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry
  • Extensive experience with SDTM model including transforming raw data files while adhering to CDISC standards
  • Understanding of ADaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus
  • Strong SAS/Base knowledge with an emphasis on data step programming is a must
  • Strong data analysis skills are required
  • Must be competent and comfortable at understanding and modifying pre-existing SAS code, as well as writing SAS code from specs
  • Understanding of clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Experience with data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer’s guides
  • Ability to provide support and/or leadership to multiple projects across a variety of therapeutic areas with minimal oversight
  • Must be able to establish and maintain effective working relationships with other statistical programmers as well as project team members in other functional areas in a highly collaborative environment.
  • Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills
  • Experience interacting with sponsors is a plus

EOE. Veterans/Disabled