Senior Statistical Programmer

This is a fully remote position, open to applicants in Egypt.

📋 Description

• Support the creation and modification of department SOPs and work instructions.

• Assist in training new statistical programmers and provide mentorship to junior-level programmers.

• Contribute to the development of study bids and modifications in scope for Statistical Programming tasks.

• Create department macros to enhance efficiency and quality.

• Act as the lead statistical programmer for assigned studies.

• Serve as the primary statistical programming liaison for both internal and external project team members.

• Collaborate with the lead statistician to oversee projects and timelines.

• Identify and relay changes in project scope and timelines.

• Provide SDTM naming conventions for database build specifications.

• Develop or supervise SDTM dataset specifications and assist with ADaM specifications and TLF shells.

• Review and create SDTM-annotated CRFs.

• Program SAS dataset deliverables, including SDTM and ADaM datasets.

• Assess Open CDISC findings and generate Reviewers Guide and Define.xml files.

• Review SAP and TLF shells, providing constructive feedback to statisticians.

• Program TLFs in accordance with mock TLF shells.

• Execute data transfers between SAS and various databases/file formats, including reconciliations.

• Evaluate data for protocol adherence, coding consistency, and plausibility.

• Conduct activities in compliance with CTI SOPs, project conventions, and GCP/ICH guidelines.

• Maintain precise work records and organize statistical programming documents in the eTMF.

• Contribute to and participate in departmental meetings.

⛳️ Requirements

• A minimum of 5 years of relevant statistical programming experience in a pharmaceutical or CRO environment, or other applicable statistical programming experience.

• Bachelor’s degree in Statistics or Biostatistics, or a proven track record of strong technical skills in statistical programming procedures.

• Experience with CDISC SDTM and ADaM dataset mapping.

• Proficiency in SAS dataset deliverables.

• Familiarity with SDTM and ADaM dataset specifications.

• Understanding of Reviewers Guide and Define.xml files.

• Capacity to adhere to Good Clinical Practice/ICH guidelines.

• Ability to keep accurate project records and organize documents in the eTMF.

• Strong communication skills to interact with internal and external project team members.

🏝️ Benefits

• Structured mentoring program.

• Leadership courses.

• Ongoing education and training opportunities.

• Tuition reimbursement.

• Dedicated training department.

• Comprehensive health benefits.

• Vacation packages.

• Hybrid work-from-home options.

• Paid parental leave.

• CTI Cares program.

• Support for work-life balance.