Statistical Programmer

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🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🖥 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

• 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 reviews, Interim Analyses, and Clinical Study Reports • Support Data Management with data-cleaning activities, including programming, reporting, reviewing, and closing statistical data issues • Review statistical programming scope of work and budget at clinical-trial initiation and identify out-of-scope tasks • Develop and maintain SDTM and ADaM define.XML/.PDF files and reviewer guides • Validate SDTMs, ADaMs, and define.XML files using Pinnacle 21 and address findings • Use global SAS macros to improve statistical programming efficiency • Participate in initiatives to develop or improve standard macros, templates, programming standards, and processes • Keep current with industry, CDISC, ICH, and regulatory standards and guidance • Collaborate with Biostatistical study teams and cross-functional departments to deliver high-quality work within timelines and budget • Review and provide input on eCRFs, edit checks, Statistical Analysis Plans, and TLF shells • May act as Lead Statistical Programmer on single studies • Complete assigned training and follow company SOPs and processes

🎯 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 guidelines; 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 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; French an asset • Must be legally able to work in India

🏖️ Benefits

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