Senior Statistical Programmer

Job not on LinkedIn

🔥 1 minute ago

🇿🇦 South Africa – 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 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), and submission packages. • Support deliverables for Data Monitoring Committee meetings, Interim Analyses, and Clinical Study Reports. • Review and provide input into Statistical Analysis Plans, TLF Shells, and Data Management documents such as eCRFs and edit checks. • 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 and participate in initiatives to improve programming efficiency and quality. • Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses. • Collaborate with Biostatistical study teams and other departments to deliver high-quality work within timelines and budget. • Mentor more junior Statistical Programmers as needed. • 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 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 able to work in South Africa.

🏖️ Benefits

• Permanent full-time position • Flexible schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Equitable treatment and equal opportunity • Recruitment and selection accommodations for applicants with disabilities, upon request