RHO

Senior Statistical Programmer

Job Location US
ID
2021-1930
Type
Regular Full-Time

Overview

The Senior Statistical Programmer designs and writes program specifications for CDISC conversions, revises programs for corrections, independently creates agency accepted eSubmission deliverables, reviews statistical analysis plan and study documents and provides feedback to Biostatistics. The person in this role will also consult with sponsors, internal and external project leads, and other programmers as well as be responsible for leading the programming team on multiple studies.

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, CRF and other data sources as well as the SAP into specifications for conversions to CDSIC
  • Convert designs and specifications into computer code and 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
  • Offers expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: reviews protocols, draft CRFs, prepares and reviews validation plans, reviews vendor DTAs, etc
  • 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 while maintaining scope and budget oversight
  • 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 from end to end (raw data to eSub)
  • 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

Rho is a full-service contract research organization optimally sized to deliver results from clinical research with agility and adaptability. Maximizing profitability, stability, and planned growth has helped provide us with the experience, capacities, and capabilities of a larger organization—all without losing touch with our entrepreneurial passion.

Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest.

Here's How We Do It

We are dedicated to a collaborative environment with fully integrated project teams and agile corporate leadership that ensures quick responses and follow-up. It is the combination of these elements that allows us to build and sustain an engaged and happy workforce. We are proud of our outstanding retention record; our talented employees tout work-life balance and close relationships with their colleagues and clients as primary reasons for joining our organization and growing their careers with us.

These are just some of the reasons Rho has consistently been named to the Triangle Business Journal's Best Places to Work.

By joining Rho, you will have the opportunity to work with some of the most talented minds in the industry to solve complex problems for our clients.

EOE. Veterans/Disabled

 

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