Senior Statistical Programmer 2

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

📋 Description

• Oversee statistical programming efforts for intricate clinical studies.

• Guarantee high-quality outcomes, efficient resource allocation, and alignment with project scopes and budgets.

• Create, test, verify, and assess SAS programs.

• Produce CDISC SDTM and ADaM datasets, along with tables, figures, listings, and other deliverables related to clinical studies.

• Offer expert advice on clinical database specifications, data transfer protocols, dataset requirements, and statistical reporting outputs.

• Act as a subject matter expert in CDISC standards, electronic data submissions, and global regulatory mandates.

• Supervise the preparation and examination of documentation ready for submission, including annotated CRFs, define.xml packages, reviewer guides, and analysis metadata.

• Promote continuous enhancement through programming standards, SAS macros, SOPs, templates, and quality management documentation.

• Mentor, coach, and provide training to Statistical Programmers, Biostatisticians, Clinical Data Managers, and other relevant stakeholders.

• Assist in proposal evaluations, budget reviews, bid defense efforts, audits, inspections, and interactions with sponsors.

• Ensure adherence to quality and regulatory standards.

⛳️ Requirements

• Bachelor's degree or an equivalent level of education.

• A minimum of 6 years of pertinent statistical programming experience in a clinical research setting.

• Proficient in advanced SAS programming, including SAS/Macro, Proc Report, ODS, BASE SAS, SAS/Graph, Proc SQL, and SAS/STAT.

• Experience in leading programming initiatives for complex clinical studies and providing technical direction to project teams.

• Comprehensive understanding of CDISC standards, particularly SDTM and ADaM.

• Background in preparing regulatory submission packages and addressing health authority requirements.

• Experience in developing and reviewing clinical study datasets, TFLs, specifications, reviewer guides, and related submission materials.

• Strong analytical, problem-solving, and detail-oriented capabilities.

• Ability to manage several priorities while delivering top-quality results.

• Capability to mentor, train, and assist colleagues and cross-functional partners.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Learning, mentoring, and training possibilities.

• Chance to contribute to innovation and ongoing improvement.

• Collaboration with a global team.