Senior Statistical Programmer

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

📋 Description

• Oversee one or several clinical trials in the capacity of a Senior Statistical Programmer.

• Create, maintain, and validate annotated Case Report Forms (aCRFs).

• Design and uphold specifications while conducting statistical programming for SDTM datasets, ADaM datasets, or derived datasets, as well as Tables, Listings, and Figures (TLFs).

• Assemble submission packages for Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), Clinical Study Reports (CSRs), and other relevant purposes.

• Evaluate and contribute to Statistical Analysis Plans (SAPs), TLF Shells, and Data Management documentation, including eCRFs and edit checks.

• Assist in data cleaning efforts by programming, reporting, reviewing, and resolving statistical data issues.

• Develop and validate SDTM and ADaM define.XML/PDF files along with reviewer guides.

• Validate SDTMs, ADaMs, and define.XMLs utilizing Pinnacle 21.

• Employ global SAS macros to enhance the efficiency of statistical programming.

• Serve as an Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and interim analyses.

• Collaborate with Biostatistical study teams and cross-functional departments to ensure high-quality deliverables are completed on time and within budget.

• Provide mentorship to junior Statistical Programmers as necessary.

• Engage in internal initiatives related to standard macros, templates, programming standards, and processes.

• Stay updated on industry trends, CDISC, ICH, and regulatory standards and requirements.

⛳️ Requirements

• Bachelor’s degree in Statistics, Computing Sciences, or a related discipline; a master’s degree is a plus.

• Minimum of 5 years of experience in clinical research within the biotechnology, pharmaceutical, or Contract Research Organization (CRO) sectors, encompassing 4 years in Statistical Programming and 1 year as a Lead Statistical Programmer.

• Strong familiarity with clinical trial data, SAP, TLF Shells, and specifications.

• Proficient in SAS; SAS certification is advantageous.

• Knowledge of XML programming is a plus.

• Comprehensive understanding of CDISC standards and guidelines; CDISC certification is a plus.

• In-depth knowledge of the drug development process, ICH guidelines (including but not limited to ICH E6, E9, and E9(R1)), as well as pertinent Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry Good Programming Practice (GPP).

• Highly organized and detail-oriented, possessing strong project planning and time management abilities.

• Capability to thrive in a fast-paced environment with a demonstrated ability to manage and prioritize multiple competing demands.

• Must be able to work both independently and collaboratively within a team.

• Excellent verbal and written communication skills in English; proficiency in French is a plus.

• Must have legal authorization to work in Argentina.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working hours.

• Work from home arrangement.

• Continuous learning and professional development opportunities.

• Attractive opportunities for career advancement.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.