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. Requirements 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 Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills Excellent knowledge of statistical programming Expertise in manipulating and analyzing SAS data Able to identify data issues, present problems, and implement solutions. Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients Excellent organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Strong interpersonal communication and presentation skills Able to effectively collaborate across cross-functional teams Focus on quality at all times and in all situations Education or Equivalent Experience A Master’s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience. Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

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 large scale projects of high complexity 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 Organize and 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 reviewers guide and analysis datasets reviewers 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. Requirements 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, SAS Macros and SAS/Graph Strong problem-solving skills Able to work independently Excellent knowledge of statistical programming Proficient in manipulating and analyzing SAS data Ability to identify data issues, present problems, and implement solutions quickly Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues Good organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models Very strong interpersonal communication, presentation, and leadership skills SAS Base, Advance and Clinical Trials Certification is preferred Education or Equivalent Experience Bachelor’s degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience. Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

Medical Coding Specialist 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 Coordinates the coding of terms for clinical trials, including review of automatically coded terms, manually coding terms, and working with the Clinical team to assure accuracy and consistency. Works under the direction of the Manager, Medical Coding for day to day technical tasks, project assignments and on-time quality delivery. Primary Responsibilities Manually encode medical terms which are not automatically encoded by the data management system Ensure consistency of the coding of terms within and across projects Communicate timely and effectively with coding team and Manager, Medical Coding of any issues, risks, concerns or technical needs regarding coding activities Contribute to and review Data Management Plans, emphasizing the Coding Conventions therein Provide input into User Acceptance Testing (UAT), specifically for coded term fields, if required Provide information to the project team about coding rationale, if requested Communicate with Clinical Data Management and Clinical Programming staff when issues arise requiring queries or system changes 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 Working knowledge of clinical trials and coding specialist role in the drug development process Excellent organizational skills Effective communication skills, both written and verbal Technical skills including: MedDRA, WHODrug Global, Microsoft Office Medidata Coder experience Certified MedDRA Coder (CMC) preferred Ability to utilize WHODrug Insight Ability to work as a part of a team 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 Working knowledge of clinical trials and coding specialist role in the drug development process Excellent organizational skills Effective communication skills, both written and verbal Technical skills including: MedDRA, WHODrug Global, Microsoft Office Medidata Coder experience Certified MedDRA Coder (CMC) preferred Ability to utilize WHODrug Insight Ability to work as a part of a team Ability to work under pressure and meet timelines Education or Equivalent Experience Bachelor s degree in applied or life science and at least 2 years of experience in clinical data medical coding. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

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 large scale projects of high complexity 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 Organize and 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 reviewers guide and analysis datasets reviewers 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, SAS Macros and SAS/Graph Strong problem-solving skills Able to work independently Excellent knowledge of statistical programming Proficient in manipulating and analyzing SAS data Ability to identify data issues, present problems, and implement solutions quickly Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues Good organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models Very strong interpersonal communication, presentation, and leadership skills SAS Base, Advance and Clinical Trials Certification is preferred Education or Equivalent Experience Bachelor s degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

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 Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills Excellent knowledge of statistical programming Expertise in manipulating and analyzing SAS data Able to identify data issues, present problems, and implement solutions. Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients Excellent organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Strong interpersonal communication and presentation skills Able to effectively collaborate across cross-functional teams Focus on quality at all times and in all situations Education or Equivalent Experience A Master s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid