Senior Statistical Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and engage in the creation and validation of high-quality CDISC datasets, utilizing implementation guides and collaborating with sponsors, project leads, systems analysts, other programmers, and end users.

• Leverage your knowledge of data standards and regulatory requirements to facilitate discussions with clients regarding optimal approaches to database design.

• Independently develop SDTM specifications from the study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides; utilize Pinnacle 21 for data conformance checks and to generate define.xml for SDTM and ADaM submissions.

• Serve as the subject matter expert on CDISC.

• Transform designs and specifications into computer code, troubleshoot code to identify errors, and revise programs accordingly.

• Document changes to computer code, programs, and specifications thoroughly and maintain accurate records.

• Review user and technical documentation created by others to ensure alignment with program operations.

• Provide expertise in statistical programming and CDASH data collection for study initiation, execution, and closure: review protocols, draft CRFs, prepare and assess validation plans, and evaluate vendor DTAs, among other tasks.

• Modify and support software programs developed by others.

• Mentor and train peers and junior programmers in your areas of expertise.

• Ensure effective, precise, and timely communication of key issues and progress to the team and senior management.

• Undertake functional lead responsibilities on assigned projects while overseeing scope and budget adherence.

• May offer guidance and input on budgets and business proposals.

⛳️ Requirements

• BA/BS in computer science, statistics, or a related field, with a minimum of 6 years of experience in statistical programming using SAS within the CRO/Pharmaceutical sector.

• Extensive knowledge and experience with the SDTM model, including the transformation of raw data files while complying with CDISC standards from start to finish (raw data to eSub); advanced comprehension of the SDTM model with experience in specification, programming, and conformance of SDTM CDISC; strong CDISC skills, particularly with SDTM End to End submissions.

• Familiarity with the ADaM model and experience in its specification, programming, and conformance to ADaM CDISC is advantageous.

• Proficient in SAS/Base, with a focus on data step programming; capable of modifying existing SAS code as well as writing SAS code based on specifications.

• Knowledge of clinical trials, including relevant clinical research regulatory standards such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Experience with data/submission conformance tools (e.g., P21), creation of define.xml, SDSP, and study data reviewer’s guides.

• Strong communication skills: Exhibit written, verbal, and presentation abilities to effectively showcase the achievements of your work and Rho’s.

• Commitment to Quality: Every position at Rho necessitates attention to detail, a profound understanding of our high-quality scientific standards, and a genuine concern for every outcome.

• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we cherish a strong team spirit defined by loyalty, accountability, and mutual trust. We collaborate smartly, work diligently, and share laughter. We take responsibility for our actions, forgive honest mistakes, and respect one another.

• Critical Thinker: Rho values thoughtful analysis. Utilize your innate creativity, refined through our intellect, training, and experience. We assess situations and opportunities objectively and incisively, crafting innovative, practical solutions.

• Agile and Adaptable: Rho values quick adaptability. We proactively anticipate, respond to, and leverage changes in our environment. We embrace risk while managing it through planning and learning from both failures and successes. The opportunity to adapt and evolve invigorates us.

🏝️ Benefits

• Rho offers a comprehensive benefits package for all eligible employees, including medical, vision, dental, HSA, FSA, EAP, life & disability insurance, and 401(k).

• All employees are entitled to paid time off, holidays, parental leave, and bereavement leave.

• Flexibility: We promote a work-life balance that empowers employees to bring their best selves to work while pursuing their passions outside of work.