Statistical Programmer

Job not on LinkedIn

🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🖥 Software Engineer

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Develop, maintain, and validate annotated Case Report Forms (aCRFs) • Develop, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets or derived datasets, and Tables, Listings, and Figures (TLFs) • Produce deliverables for Data Monitoring Committee data review meetings, Interim Analyses, and Clinical Study Reports • Support Data Management with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues • Use global SAS macros to improve statistical programming efficiency • Participate in internal initiatives to improve efficiency and quality, including standard macros, templates, programming standards, and processes • Develop, maintain, and validate SDTM and ADaM define.XML/PDF files and reviewer guides • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address findings • Collaborate with Biostatistical study teams, Statistical Programmer counterparts, Lead Biostatisticians, Data Management, and other departments • Review statistical programming scope of work and budget at clinical trial initiation and identify out-of-scope tasks • Ensure deliverables meet timelines, budgets, ICH guidelines, pharmaceutical industry standards, regulatory requirements, and company SOPs • Review and provide input on eCRFs, edit checks, SAPs, and TLF shells • May act as Lead Statistical Programmer on single studies • Keep current with industry, CDISC, ICH, and regulatory standards and guidance

🎯 Requirements

• Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset • At least 1 year of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 1 year of Statistical Programming • Significant exposure to clinical trial data, SAP, TLF Shells, and specifications • Excellent working knowledge of SAS; SAS certification an asset • Knowledge of XML programming an asset • Good knowledge of CDISC standards and guideline; CDISC certification an asset • Good knowledge of drug development process, ICH guidelines, relevant Health Canada and FDA regulations, guidelines, electronic data submission requirements, and Pharmaceutical Industry Good Programming Practices • Very organized and detail-oriented, with effective project planning and time management skills • Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands • Must be able to work independently and as part of a team • Strong verbal and written communication skills in English; French an asset • Must be legally able to work in Romania

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request