Clinical Outcomes Solutions

Software Engineer

• Work independently on clinical development programs across different therapeutic areas
• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies
• Develop SAS and/or R programs producing datasets, complex listings, tables, descriptive and standard inferential statistics, and complex graphs
• Develop, validate, and maintain statistical programming programs tailored to clinical development needs
• Oversee CRO statistical programming deliverables for multiple clinical studies
• Support clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses
• Follow FDA regulations, good clinical practice, and electronic-submission guidelines for clinical trial data reporting
• Create, maintain, document, and validate standards for programming tools, outputs, and macros
• Participate in developing CRFs, edit check specifications, and data validation plans
• Review and/or author data transfer specifications for external vendor data
• Collaborate with CROs, software vendors, clinical development partners, and internal functions to meet project timelines and goals
• Review and/or author SOPs and work instructions related to statistical programming practices
• Provide expert technical support to team members and track progress

Principal Statistical Programmer

Clinical Research

• Support Phase I-IV clinical studies
• Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions
• Provide statistical support to clinical studies
• Participate in study protocol development, study design discussions, and sample size calculations
• Review CRFs and data review guidelines
• Develop statistical analysis plans (SAPs), including analysis dataset and TLG specifications
• Perform statistical analyses and interpret statistical results
• Prepare clinical study reports, including integrated summaries for submissions
• Present and explain methodology and the consequences of decisions
• Work fully embedded within and dedicated to a global pharmaceutical client while supported by Cytel
• Collaborate with clinical, regulatory, programming, internal, and external teams

Principal Biostatistician – FSP

• Provide statistical support to clinical studies
• Participate in study protocol development, study design discussions, and sample size calculations
• Review CRFs and data review guidelines
• Develop statistical analysis plans, including analysis dataset and TLG specifications
• Perform statistical analyses and interpret statistical results
• Prepare clinical study reports, including integrated summaries for submissions
• Present and explain methodology and consequences of decisions
• Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in developing CRFs, edit check specifications, and data validation plans
• Review or author data transfer specifications for external vendor data
• Collaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goals
• Review or author SOPs and work instructions related to statistical programming practices

Senior Biostatistician

• Perform data manipulation, analysis and reporting of clinical trial data, including safety and efficacy, using SAS programming
• Generate and validate SDTM and ADaM datasets/analysis files and tables, listings, and figures (TLFs)
• Perform production and QC/validation programming
• Generate complex ad-hoc reports using raw data
• Apply strong understanding and experience of efficacy analysis
• Create and review submission documents and eCRTs
• Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, and inquiries
• Contribute as a team player to achieve results and meet deadlines
• Adapt to changing priorities

Senior Statistical Programmer, FSP

• Lead or support data management study activities, CRO oversight, and deliverable timelines
• Build and oversee EDC systems
• Represent data management on Clinical Sub-teams and align CRO and client expectations for data-related deliverables
• Collaborate with client stakeholders to meet milestones and deliverables with high quality
• Partner with stakeholders and CROs to mitigate and resolve risks
• Provide input to functional governance with strategic suppliers and resolve escalated issues
• Prepare the function for submission readiness and represent it in inspections or audits
• Ensure archival and inspection readiness of Data Management Trial Master File documents
• Coordinate data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics
• Plan and manage external Data Management budgets and timelines, analyze variances, and improve forecasting
• Act as a process expert for operational and oversight models
• Maintain SOPs, process maps, templates, and timelines
• Prepare metrics supporting functional KPIs
• Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA
• Contribute strategic direction to continuous improvement initiatives
• Ensure compliance with learning curricula, corporate, and GXP requirements
• Work cross-functionally to ensure database data quality, on-time delivery, and quality of other data management deliverables

Principal Statistical Programmer

Principal Biostatistician – FSP

Senior Biostatistician

Senior Statistical Programmer, FSP

Senior Clinical Data Manager