Senior Statistical Programmer

Role Overview

• 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 your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design
• Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions
• Act as the CDISC subject matter expert
• 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
• Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: review protocols, draft CRFs; prepare and review validation plans, review 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

Requirements

• BA/BS in computer science, statistics, or related field along with at least 6 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry
• Extensive experience and understanding in SDTM model including transforming raw data files while adhering to CDISC standards from end to end (raw data to eSub); advanced understanding of SDTM model and experience with; both specification, programming, and conformance of SDTM CDISC; strong CDISC skills with an emphasis on SDTM End to End submissions experience
• ADaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus
• SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs.
• Clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer’s guides
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• 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.

Tech Stack

• Google Cloud Platform

Benefits

• Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).
• All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
• Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.