Senior Statistical Programmer

Job not on LinkedIn

🔥 14 hours ago

🇮🇳 India – 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 as a Senior or Lead Statistical Programmer. • 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, 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 such as eCRFs and edit checks. • Support Data Management with data-cleaning activities, including programming, reporting, reviewing, and closing statistical data issues. • Develop and maintain SDTM and ADaM define.XML/PDF files, clinical SDTM Reviewer’s Guides, and ADaM Reviewer’s 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 with Biostatistical study teams and cross-functional departments to deliver high-quality work within timelines and budget. • Contribute to and participate in internal initiatives involving standard macros, templates, programming standards, and processes. • Mentor more junior Statistical Programmers as needed. • Keep current with industry and CDISC standards, ICH guidance, and regulatory 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, including 4 years of Statistical Programming and 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 guideline; CDISC certification an asset. • Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. • 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 authorized to work in India.

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities