Principal Clinical Data Manager Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary The Principal Clinical Data Manager assists the Manager, Data Management in the oversight and execution of Data Management operations. Provides oversight for all data management operational activities in support of both clinical and non-clinical research studies from study build through study close. Mentors and trains Clinical Data Management staff. Primary Responsibilities Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by management. Serve as a subject matter expert Participate in Business Development presentations and bid development Assigns tasks and responsibilities within Data Management to team members that optimizes team capacity, delivery of timely accurate results and supports the needs of the business. Provide mentoring and coaching to data management staff in daily operational activities Communicate with cross functional groups and stakeholders throughout the project lifecycle Manage sponsor relationships and triage issues as appropriate Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections Maintain Quality control of the clinical data, project deliverables and closeouts Adhere to all aspects SDC s quality system Comply with SDC s data integrity and business ethics requirements Perform other duties as assigned Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Exceptional working knowledge of clinical trials and the data management role Excellent organizational and project management skills Expert knowledge and understanding of ICH Guid

Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis. Primary Responsibilities Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on medium to large scale projects Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams Review the Statistical Analysis Plan in preparation for programming the planned analyses Lead design/development of SAS macros and other utilities to expedite SAS programming activities Conduct internal training sessions and author papers for conferences Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request Participate in statistical program validation and quality control activities Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines Develop define.xml, study data reviewer s guide and analysis datasets reviewer s guide Identify study priorities and communicate effectively with project team and management Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours Manage statistical programming timelines, budgets, and client expectations Actively participate in study team meetings Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management Program data cleaning checks, as necessary, to assist Data Management s data cleaning activities Participate in installation/validation of statistical software packages throughout the software development lifecycle Develop and maintain the infrastructure for project files of SAS datasets and SAS code Mentor junior level statistical programmers by developing training plans and providing oversight of their work Ensure all programming activities and processes performed are conducted according to SDC s standard procedures and/or sponsor requirements Adhere to all aspects of the SDC s quality system Comply with SDC s data integrity business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Strong analytical skills, with the ability to process scientific and medical data Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros Basic und

Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating basic SDTM datasets, safety listings, and safety tables, for clinical trials. Primary Responsibilities Perform assigned statistical programming required for clinical trial analysis and reporting. Work under the direction of senior statistical programmers in completing clinical trial programming tasks. Assist in programming and validation of less complex CDISC SDTM and ADaM datasets. Generate safety listings and tables per protocol, Statistical Analysis Plan. Participate in statistical program validation and quality control activities, as assigned. Apply appropriate statistical methods for data analysis. Develop define.xml and create table of contents of programs for regulatory submissions. Assist in the review of study documents, programs and reports. Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects. Timely completion of assigned tasks. Ensure all programming activities and processes performed are conducted according to SDC s standard procedures and/or sponsor requirements. Adhere to all aspects of the SDC s quality system. Comply with SDC s data integrity business ethics requirements. Perform other related duties incidental to the work described herein. Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Sound analytical skills, with the ability to process scientific and medical data. Basic SAS programming skills required, with working knowledge in SAS/BASE and SAS Macros. Exposure in manipu

Principal Biostatistician Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning. Primary Responsibilities Serve as an internal consultant for biostatistics analysis tools and methods Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support Actively support business development in capabilities presentations to prospective and current clients Effectively manage assigned clinical study budgets for biostatistics analysis support Develop, coach and mentor junior biostatistics department personnel Act as the lead statistician on clinical research projects and help with SAS programming Provide statistical expertise for study design of clinical trial protocols Write statistical methods section of the study protocol, as needed Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP) Program summary tables, data listings and graphical representations of clinical trials data Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data Prepare/review key sections of clinical study reports and various regulatory documents Perform statistical QC of all department outputs including analyses and clinical study reports Provide statistical support to answer questions from external clients (such as FDA, Investigators) Contribute to the development, maintenance, and training of standard operating procedures (SOPs) Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed Manage biostatistics timelines, budgets, and client expectations Adhere to all aspects of the Statistics Data Corporation s quality system Comply with Statistics Data Corporation s data integrity business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Effective leadership, budget forecast and implementation skills Excellent analytical skills, with the ability to process scientific and medical data Able to work independently and in teams

Senior Software Developer Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Primary Responsibilities Designs, develops, and maintains existing automation applications using test driven development Maintain Azure based cloud-based resources Engages with various internal cross-functional departments to develop and implement software applications while understanding the underlying data Increases team productivity by developing, identifying, and implementing better tools and processes Exemplifies good documentation, coding, and testing best practices Develops standard operating procedures for the creation and maintenance of applications. Prototypes new ideas/technologies to create proof of concept and demos Provides mentorship for other software developers Assist in executing responsibilities of Software Developers including the following: o Develops and maintains existing automation applications using test driven development o Assists in the design of new applications o Maintain existing cloud resources o Delivers high quality software design documentation o Prototypes new ideas/technologies to create proof of concept and demos o Contributes to the development of standard operating procedures o Performs other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements Act as a resource for other team members for debugging, code reviews and other software development lifecycle activities The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.