Senior Statistical Programmer

Job not on LinkedIn

🔥 15 hours ago

🇵🇭 Philippines – Remote

⏰ Full Time

🟠 Senior

🖥 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.

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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 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, and Clinical Study Reports • Review and provide input into Statistical Analysis Plans, TLF Shells, eCRFs, edit checks, and other Data Management documents • Support data cleaning 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 • Contribute to and participate in internal initiatives involving standard macros, templates, programming standards, and processes • Collaborate with Biostatistical study teams and other departments to deliver high-quality work within timelines and budget • Ensure compliance with ICH guidelines, pharmaceutical industry standards, regulatory requirements, and company SOPs • Keep current with industry, CDISC, ICH, and regulatory standards • Mentor more junior Statistical Programmers as needed

🎯 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 • 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 the Philippines

🏖️ Benefits

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