Senior Statistical Programmer

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

📋 Description

• Oversee one or more clinical trials

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

• Develop, maintain, and validate specifications along with statistical programming for SDTM datasets, ADaM datasets, or derived datasets, including Tables, Listings, and Figures (TLFs)

• Assemble submission packages for DMC data review meetings, Interim Analyses, Clinical Study Reports, and other related purposes

• Review and offer insights into Statistical Analysis Plans, TLF Shells, and Data Management documents

• Assist with data cleaning processes through programming, reporting, reviewing, and resolving statistical data issues

• Create and validate SDTM and ADaM define.XML/PDF files and reviewer guides

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

• Employ global SAS macros to enhance programming efficiency

• Serve as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses

• Collaborate with Biostatistical study teams and across departments to ensure high-quality deliverables within timelines and budget constraints

• Mentor junior Statistical Programmers as necessary

• Engage in and contribute to internal initiatives focusing on standard macros, templates, programming standards, and processes

• Stay updated with industry, CDISC, ICH, and regulatory standards and requirements

⛳️ Requirements

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

• Minimum of 5 years of clinical research experience within the biotechnology, pharmaceutical, or Contract Research Organization (CRO) sectors

• At least 4 years of experience in Statistical Programming

• A minimum of 1 year serving as a Lead Statistical Programmer

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

• Proficient working knowledge of SAS; SAS certification is an advantage

• Familiarity with XML programming is a plus

• In-depth understanding of CDISC standards and guidelines; CDISC certification is an asset

• Comprehensive knowledge of the drug development process, ICH guidelines, and relevant Health Canada and FDA regulations, as well as electronic data submission requirements and Pharmaceutical Industry Good Programming Practices (GPP)

• Strong project planning and time management capabilities

• Ability to thrive in a fast-paced environment and prioritize multiple competing demands

• Capacity to work independently and collaboratively as part of a team

• Excellent verbal and written communication skills in English

• Must be legally authorized to work in Romania

🏝️ Benefits

• Permanent full-time employment

• Flexible working hours

• Remote work opportunity

• Continuous learning and development

• Attractive opportunities for career advancement

• Fair treatment and equal opportunity

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