Statistical Programmer II

Responsibilities

• Participate in and may lead 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
• May 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
• May 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 along with at least 2 years of experience 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; 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 preferred
• Ability to provide support and/or leadership to multiple projects across a variety of therapeutic areas with minimal oversight
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho's. Fluency in both English and local languages.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.