Everest Clinical Research

Software Engineer

• Develop and review SDTM and ADaM dataset specifications
• Program and validate SDTM and ADaM datasets
• Develop SAS programs to generate and validate statistical output reports
• Provide statistical programming support to Clinical Study Reports
• Develop and maintain SAS programs to perform database integrity checks
• Document data and programming information according to SOPs and WIs

Statistical Programmer II

• Lead projects with higher level of complexity/challenges/difficulties
• Resolve complex statistical programming issues or problems
• Perform a leadership role in statistical programming projects by coordinating study team(s)
• Oversee timelines, assign and follow up on programming tasks
• Interact with clients and ensure quality of programming deliverables
• Assist in properly planning and allocating resources based on timelines
• Develop and maintain clinical trial data and statistical programming standards
• Perform hands-on primary statistical programming and validation programming on assigned projects
• Create SDTM mapping specifications and ADaM data specifications
• Perform quality control (QC) review of programming deliverables
• Provide training, mentorship, and technical guidance to less experienced Statistical Programmers

Principal Statistical Programmer

Data Scientist

• Plan, manage, control, and perform data processing and management activities for assigned projects
• Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques
• Manage timelines and coordinate activities for assigned projects
• Specify database validation checks for assigned studies
• Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules
• Define and monitor clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines
• Perform clinical trial site monitors’ training on dataflow and QC processes
• Design and review patient Case Report Forms (CRFs) and database schema
• Test data capture/entry screens
• Accurately and efficiently validate electronically captured data
• Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks
• Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area specific modules
• Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study
• Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data
• Validate and distribute study progress status reports to internal and external study team members
• Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures, and medications
• Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation
• Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies.

Clinical Data Manager

Clinical Research

• Participate and/or lead efforts in resolving day to day work related issues and problems
• Assist the Lead Biostatistician and/or Lead Programmer on assigned projects
• Coordinate with other Biostatisticians and Programmers as well as project/program overall management personnel
• Provide statistical expertise for design, analysis and reporting of clinical trials and research projects
• Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes
• Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments
• Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs
• Provide input to unblinded data management plan when required
• Participate in research and development of statistical methodologies and processes
• Develop and/or review SDTM and ADaM dataset specifications
• Perform statistical programming
• Participate in statistical dry runs and final run
• Develop SDTM Study Data Reviewer’s Guide
• Develop ADaM Analysis Data Reviewer’s Guide
• Perform statistical modeling and analyses, implement new statistical analysis methods and strategies
• Plan and conduct or contribute to the trial results reporting/dissemination meetings
• Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results
• Perform statistical analyses for publications

Biostatistician I

• Lead efforts in resolving day to day work related issues and problems
• Provide statistical expertise for design, analysis and reporting of clinical trials and research projects
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP
• Provide statistical input to Case Report Forms (CRF) design and database/variable structure

Senior Biostatistician

• Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients.
• Provide day to day technical and operational leadership to project teams supporting these programs/projects.
• Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
• Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects.
• Provide statistical input in protocol design and development.

Principal Biostatistician

• Lead projects with higher level of complexity/challenges/difficulties, and lead efforts to resolve complex statistical programming issues or problems.
• Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business.
• May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.
• Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.
• Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements.

• Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
• Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Key Accountabilities:
• Lead Data Management Activities, Perform Training and Client Relationship Management
• Develop and maintain Data Management Project Plan (Plan).
• Document deviations from the Plan, log and report issues, and follow up on their resolutions.
• Is the primary contact person for day to day data management activities, and is responsible for all data management deliverables for assigned projects.
• Provide training to new data management personnel on data management processes and procedures.
• Perform QC review of work performed by less experienced data management personnel.
• Design and review case report forms (CRFs/eCRFs) and develop data validation specifications.
• Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases.

Senior Clinical Data Manager I

• Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables.
• Lead assigned projects by applying project management skills and statistical programming techniques.
• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE.
• Perform quality control (QC) review of documents prepared by others.
• Program and validate SDTM and ADaM datasets following approved dataset specifications.
• Perform CDISC standard compliant checks on SDTM and ADaM datasets.
• Generate, review, and resolve Pinnacle 21 validation issues.
• Perform additional QC checks using company Working Instruction (WI) QC checklists.
• Perform overall quality/consistency review of statistical TLGs.
• Create SDTM and ADaM define.xml files.
• Perform QC review of these files prepared by others.
• Participate and/or lead programming teams in support of product regulatory submission activities.
• Learn and maintain expertise in utilities and macros for Statistical Programmers.
• Develop new macros and utilities.
• Program and perform QC/validation of complex data integrity checks.
• Complete job-required and project-specific training.
• Comply with applicable policies, SOPs, and WIs.
• Document data and programming information in accordance with corporate SOPs and guidelines.

Senior Statistical Programmer

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• Lead efforts in resolving day to day work related issues and problems
• Provide statistical expertise for design, analysis and reporting of clinical trials and research projects
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP
• Provide statistical input to Case Report Forms (CRF) design and database/variable structure
• Plan and carry out professional development activities

Director

• Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects.
• Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
• Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers.
• Perform semi-annual and annual performance review and develop developmental plans for direct subordinates.
• Lead statistical and programming teams, interact with clients to deliver quality deliverables.

Associate Director, Biostatistics

Clinical Operations

• Take a leadership role in facilitating the efforts of functional area directors and managers in project planning
• Manage projects from initiation through closure for full scope regional and global projects
• Perform project progress tracking for responsible projects using project planning and tracking methods, tools, and software
• Provide monthly project progress status reports for individual ongoing projects
• Prepare project status reports and maintain accurate and current details
• Present project status to internal and external stakeholders inclusive of comprehensive risk identification and sound mitigations
• Conduct responsible project progress status meetings with individual project teams periodically
• Work with the functional area directors and managers to jointly ensure smooth project start-up, continuation, and successful completion
• Act as the project management lead interfacing with clients to drive project delivery, communication, problem solving, and issue management
• Coordinate activities between Everest and trial Sponsors, and with various supporting groups or vendors when necessary
• Lead cross-functional project teams.

Statistical Programmer II

Principal Statistical Programmer

Clinical Data Manager

Biostatistician I

Senior Biostatistician

Principal Biostatistician

Principal Statistical Programmer

Senior Clinical Data Manager I

Senior Statistical Programmer

Senior Biostatistician

Senior Biostatistician

Associate Director, Biostatistics

Senior Clinical Project Manager