Senior Statistical Programmer

🔥 5 minutes ago

🇪🇬 Egypt – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Assist with development and modification of department SOPs and work instructions • Assist with training new statistical programmers and mentor junior-level programmers • Assist with development of study bids and changes in scope for Statistical Programming tasks • Develop department macros to maximize efficiency and quality • Serve as lead statistical programmer on assigned studies • Act as primary statistical programming contact for internal and external project team members • Work with the lead statistician to manage projects and timelines • Identify and communicate changes in project scope and timelines • Provide SDTM naming conventions for database build specifications • Develop or oversee SDTM dataset specifications and assist with ADaM specifications and TLF shells • Review and develop SDTM-annotated CRFs • Program SAS dataset deliverables, including SDTM and ADaM datasets • Review Open CDISC findings and generate Reviewers Guide and Define.xml files • Review SAP and TLF shells and provide feedback to statisticians • Program TLFs according to mock TLF shells • Perform data transfers between SAS and databases/file formats, including reconciliations • Review data for protocol adherence, coding consistency, and plausibility • Perform activities according to CTI SOPs, project conventions, and GCP/ICH guidelines • Maintain accurate work records and file statistical programming documents in the eTMF • Provide input to and participate in departmental meetings

🎯 Requirements

• At least 5 years of related statistical programming experience in a pharmaceutical or CRO environment or other relatable statistical programming experience • Bachelor’s degree in Statistics or Biostatistics, or demonstration of excellent technical ability in statistical programming procedures • CDISC SDTM and ADaM dataset mapping experience • Experience with SAS dataset deliverables • Knowledge of SDTM and ADaM dataset specifications • Knowledge of Reviewers Guide and Define.xml files • Ability to work according to Good Clinical Practice/ICH guidelines • Ability to maintain accurate project records and file documents in the eTMF • Ability to communicate with internal and external project team members

🏖️ Benefits

• Structured mentoring program • Leadership courses • Ongoing education and training • Tuition reimbursement • Dedicated training department • Generous health benefits • Vacation packages • Hybrid work from home opportunities • Paid parental leave • CTI Cares program • Work-life balance support