Clinical Outcomes Solutions

Business Analyst

• Supports cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification, and evaluation into Risk MAP.
• Support RBQM Leads in selection and implementation of Key Risk Indicators (KRIs), and Quality Tolerance Limit parameters (QTLs) and other applicable assessments and dashboards, conducting end of trial summarization of risk management activities for inclusion to Clinical study report.
• Drafts and oversee RBQM system set up specifications.
• Perform the execution and review of the Study’s assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks.
• Raise signal and issues in RBQM systems and raise actions as appropriate in RBQM system.
• Delivers timely high-quality analytics and supporting RBQM leads in communication to the cross-functional study team to identify resolution.
• Collaborate with assigned programmer to implement study-specific KRIs, QTLs, visualizations, and other analytics in the RBQM system.
• Perform QC study setup in RBQM system vs RBQM system specifications, if required.
• Act as RBQM programmer on set up of KRIs, QTLs, data quality assessments as well as visualizations in the RBQM system, if required.
• Perform the maintenance of the Risk-Based Quality Management (RBQM) system based on RBQM Plan requirements, data sources and structure.
• Ensure appropriate status and process documentation are produced and maintained during the study.
• Communicate and/or escalate serious risks and issues to the RBQM Lead, study team and/or management and Quality, as needed.
• Ensure inspection readiness for clinical risk management and centralized monitoring activities.

Clinical Insights Analyst I

Software Engineer

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming.
• Applying your CDISC know-how and proficiency to create and validate safety and efficacy SDTMs.
• Creating and validating pooled analysis datasets (ADaMs), tables, listings, and figures (TLFs);
• Preparing submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21.
• Generating complex ad-hoc reports.
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change.

Senior Statistical Programmer

Data Scientist

• Responsible for vendor oversight activities across global development programs.
• Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Provides input to functional governance with client strategic suppliers. Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
• Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
• Participates and represents function in formal inspections and audits as requested.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• Acts as a process expert for operational and oversight models.
• Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
• Contributes or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
• Performs other duties as assigned.

Principal Clinical Data Manager

• Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
• Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
• Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
• Oversee the reengineering of critical data management functions, including: Study Set-Up, EDC Build and Maintenance, Data Cleaning and Query Management, Local Lab and External Data Handling, Clinical Coding, SAE Reconciliation, Blinding Procedures, Site Close-Out and Database Lock, DM Metrics and Clean Patient Tracker.
• Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
• Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
• Supports audit readiness and continuous improvement initiatives.

Clinical Research

• Providing statistical support to clinical studies
• Participating in the development of study protocols, including participation in study design discussions and sample size calculations
• Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
• Performing statistical analyses and interpreting statistical results
• Preparing clinical study reports, including integrated summaries for submissions
• Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Senior Biostatistician – FSP

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
• Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Principal Statistical Programmer – FSP

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Principal Statistical Programmer – Oncology

Principal Statistical Programmer

Director

• Develop and implement strategic plans to help achieve revenue targets and maximize profitability for Cytel's software solutions.**• Build and maintain strong relationships with key stakeholders across the pharmaceutical and biotech industries, including C-suite executives, decision-makers, and influencers.**• Identify new business opportunities and develop innovative strategies to expand Cytel's customer base and penetrate new markets.**• Collaborate closely with cross-functional teams, including marketing, product development, and customer success, to ensure alignment and execution of initiatives.**• Stay abreast of industry trends, competitive landscape, and customer needs to inform product development, pricing strategies, and go-to-market plans.**• Represent Cytel at industry events, conferences, and customer meetings to promote our brand, showcase our products, and build relationships with key stakeholders.**• Ensure compliance with all relevant regulations, policies, and procedures, and uphold the highest standards of ethical conduct in all activities.**

Senior Director, Product Solutions

• Leads statistical support for post approval value evidence generation and reimbursement submissions.
• Conducts post hoc analysis to support publications and presentations.
• Reviews and authors abstract, manuscript, regulatory documents.
• Collaborates with cross-functional team to support observational studies.
• Develops statistical sections of study protocols and statistical analysis plans.
• Collaborates with Data Management and Medical Research on design of eCRFs.
• Provides statistical guidance on conduct of ongoing studies.
• Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs.
• Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
• Contributes to scientific articles, summarizing data collected in sponsor studies.
• Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.

Principal Biostatistician – Medical Affairs

• Provide technical leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor
• Provide technical leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
• Ensure compliance with company SOP'S and FDA/ICH/GCP regulations
• Perform quality control checks of advanced SAS code for datasets and output produced by other statistical programmers
• Review, maintain study documents per standard process
• Program, test, and document global utility programs and tools in accordance with standards and validation procedures
• Conduct briefings and participate in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects
• Perform lead duties when called upon
• Perform other duties as assigned