Senior Statistical Programmer

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🔥 0 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 12%

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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

• Lead single and/or multiple clinical trials • 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) • Prepare submission packages for DMC data review meetings, Interim Analyses, Clinical Study Reports, and other purposes • Review and provide input into Statistical Analysis Plans, TLF Shells, and Data Management documents • Support data cleaning activities by programming, reporting, reviewing, and closing statistical data issues • Develop and validate SDTM and ADaM define.XML/PDF files and reviewer guides • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 • Use global SAS macros to improve programming efficiency • Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses • Collaborate within Biostatistical study teams and across departments to deliver high-quality work within timelines and budget • Mentor junior Statistical Programmers as needed • Contribute to and participate in internal initiatives involving standard macros, templates, programming standards, and processes • Keep current with industry, CDISC, ICH, and regulatory standards and requirements

🎯 Requirements

• Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset • At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry • At least 4 years of Statistical Programming experience • At least 1 year acting as a Lead Statistical Programmer • Excellent 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 • Excellent working knowledge of CDISC standards and guidelines; CDISC certification an asset • Excellent knowledge of drug development process, ICH guidelines, relevant Health Canada and FDA regulations, guidelines, electronic data submission requirements, and Pharmaceutical Industry GPP • Strong project planning and time management skills • Ability to work in a high-speed environment and prioritize multiple competing demands • Ability to work independently and as part of a team • Strong verbal and written communication skills in English • 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 • Equitable treatment and equal opportunity • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request