Everest Clinical Research

• Lead Data Management Activities • Perform Training and Client Relationship Management • Develop and maintain Data Management Project Plan • Document deviations from the Plan, log and report issues • Primary contact for data management activities • Responsible for planning and implementing data management timelines • Assist with study-level resource planning • Provide training to new data management personnel • Perform QC review of work performed by less experienced data management personnel • Create and maintain clinical trial Data Management Study Binders

• 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 • Specify database validation checks for assigned studies • Define and monitor clinical trial data flow and quality control (QC) processes • Train and supervise Data Entry personnel and junior data management personnel

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems. • Perform post go-live changes (database modifications) based on updated requirement specifications. • Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings. • Set up and configure the development environment for new studies. • Review study design requirement specifications for assigned projects, ensuring adherence to EDC platform standards and Everest Standards. • Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.

• Own the end-to-end intake and delivery of project/opportunity proposals • Analyze clinical research protocols and opportunity and client requirements • Drive and develop on-time, high quality, functionally and technically sound proposals • Act as a central bid leader to plan, notify, coordinate and follow up with internal and external parties • Support the coordination and execution of bid defense meetings, project contracting, transition of key information to project delivery teams • Support capability building for the proposals/contracts and business development function at Everest

• Develop new features and functionality within the database design functional areas • Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process • Review the protocol and associated study reference materials • Maintain database design timelines • Follow up on regulatory requirements, industry trends, benchmarking, and best working practices • Design and review case report forms (CRFs/eCRFs) • Author and review the Data Validation Specifications • Develop and review User Acceptance Test (UAT) plans • Coordinate and oversee the UAT process • Design and review patient Case Report Forms and database schema • Test data capture/entry screens through UAT • Participate in EDC vendor’s technical learning and exchange meetings • Provide user training to CRAs on EDC systems • Contribute to the development and maintenance of the company’s database design procedural documents • Plan, manage, control and perform data processing activities for assigned projects • Review the Data Management Plan (DMP) • Review data, issue and resolve queries • Assist in resolving medical coding discrepancies • Cooperate with the Quality Assurance Department with quality control audits • Define and monitor clinical trial data flow and quality control processes • Accurately and efficiently validate electronically captured data • Write clear queries on missing data and data points failing pre-defined range checks • Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports.

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems • Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems and provide impact assessment for modifications • Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings • Set up and configure the development environment for new studies • Assist the creation of the Database Integration Specification (DIS) with other systems, provide Integration Technical Detail (ITD) as needed, program the integration, and assist the integration test • Support the Data Manager in investigating and addressing issues related to the database design • Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest Standards • Maintain database design timelines and promote good project management practices • Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities • Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.

• Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities • Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process • Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline • Maintain database design timelines and promote good project management practices • Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities • Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trials • Author and review the Data Validation Specifications for assigned projects • Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers • Coordinate and oversee the UAT process for clinical databases • Design and review patient Case Report Forms and database schema • Test data capture/entry screens through UAT • Participate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetings • Participate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes • Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems • Provide input to all data management procedural documents • Plan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements • Review the Data Management Plan (DMP) for assigned projects • Review data, issue and resolve queries • Assist the Lead Data Manager, sponsor or Investigative Site with resolving queries • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products • Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases • Validate and disseminate real-time study monitoring reports to sponsor and internal team members • Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines • 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 • Participate in and contributes to Clinical Data Management initiatives • Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports

• Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations • 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, and address peer/QC review comments and findings • Provide statistical input to Case Report Forms (CRF) design and database/variable structure

• Taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation • Ensures that ongoing projects have existing project plans as required by the established Standard Operating Procedures (SOPs) • Ensures that project progress status is tracked and reported, and issues are promptly identified and resolved • Works with functional area directors and managers to be jointly accountable for smooth project start-up, continuation, and successful completion • Interacts with clients for projection of resource requirements and project management purposes • Responsible for defining project scope and estimating budgets, planning, directing, leading project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities • Accountable for reporting of project progress status to Everest internal management and its clients • May assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), and subsequently defining scope of work and budgets, and performing contract administration activities

Role Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Statistical Programmer II for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy. Key Accountabilities: - Statistical Programming: - Under supervision, may develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents (e.g., define.xml, reviewer’s guide) based on Statistical Analysis Plan (SAP), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements. - Program and validate SDTM and ADaM datasets following approved dataset specifications; perform CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings. - Develop SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock-up shells. - Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g. Development Safety Update Report, 120 Day Safety Update, etc.), ad-hoc requests, and exploratory data analyses. - Clinical Data Acquisition and Cleaning Support: - Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review. - Support data acquisition of non-CRF data by developing SAS programs to reconcile the CRF and non-CRF data and performing data integrity checks of the non-CRF data. - Develop SAS programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.). - Develop SAS programs to generate Patient Profiles to support trial subject case review activities. - Document data and programming information in accordance with Everest company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits. - Achieve a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators. - Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements when applicable. - Comply to Everest company-specific and clinical trial Sponsor-specific training requirements. - Develop and provide expertise in other programming and system administration areas when required. Qualifications - A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences. - SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred. - Exposure/experience in clinical trial statistical programming and/or data analysis is desirable. Benefits - Robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - 401(k) retirement plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. Company Description 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. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.