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! Show more Show less

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 Offic eMedidata Coder experienc eCertified MedDRA Coder (CMC) preferre dAbility to utilize WHODrug Insigh tAbility to work as a part of a tea mThe 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 .Requirement sRequired Skill sWorking knowledge of clinical trials and coding specialist role in the drug development proces sExcellent organizational skill sEffective communication skills, both written and verba lTechnical skills including{​{:}} MedDRA, WHODrug Global, Microsoft Offi ceMedidata Coder experien ceCertified MedDRA Coder (CMC) preferr edAbility to utilize WHODrug Insig htAbility to work as a part of a te amAbility to work under pressure and meet timelin esEducation Or Equivalent Experien ceBachelor's degree in applied or life science and at least 2 years of experience in clinical data medical codi ngBenefi tsWhy S DCSDC 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 industr y. 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 benefi ts We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitme nt We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture cl ub 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 indust ry With a proven track record, SDC has been successfully executing client clinical programs since 20 05Take a look at how you can join our tea m! Show more Show less

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 Direct the development and maintenance of the required systems, infrastructure, and personnel to enable reliable, cost effective, automation and machine learning solutions available within SDC and to external partners and clients. Ensure systems and applications have appropriate validation documentation in place according to standard operating procedures. Maintain portfolio of requested and completed applications, including metrics around resource needs (internal and external to DI&A), and intended goal of the application to enable discussion around prioritization. Develop agile development practices on large initiatives to ensure alignment with the specific company goals. Participate in the identification of cross department company goals and initiatives. Oversee the continued effort to clean, process, store and analyze clinical data with its application towards research and development of Artificial Intelligence (AI) and Machine Learning (ML) algorithms supporting better understanding of the safety and efficacy of new therapies. Contribute to the organization's strong drive to be at forefront of using AI in clinical trials to simplify data processing and discover imperceptible correlations. Lead and manage software development activities to drive automation across SDC departments reducing error and increasing efficiency across those departments. Serve as the primary point within the company driving standardization. Primary Responsibilities Oversee day to data activities involving data science, data engineering, automation, and business intelligence Develop standard metrics demonstrating model performance, robustness, and validity Engage with various internal departments such as data management, technology solutions, biostatistics, statistical programming, project management, IT, and business development to strategically identify areas to apply AI and/or ML toward increasing the efficiency of processes and detecting information trends Ensure that algorithms can be practically deployed with minimal resource usage and maximum ease of use in existing architecture Oversee the delivery of high-quality software design documentation Develop ML models which autonomously identify inconsistent information in patient data and discover the correlations between patient data and medically relevant conditions such as a specific adverse event or high efficaciousness Prototype new ideas/technologies to create proof of concept and demos Develop standard operating procedures for the use of artificial intelligence within clinical trials Develop and communicate roadmap of activities and updates quarterly to executive management Ensure timelines and delivery are met and raise issues early for any risks 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 Experience with an AI framework such as{​{:}} Tensorflow, MXNet, Theano, Keras, Pytorch, Caff e Experience in Pytho n Experience in the software development process{​{:}} Evidence of delivering production level co de Familiarity with AI algorithms for problems, including natural language processing, classification, clustering, dimensionality reduction, anomaly detecti on Experience in applying AI to biomedical data analysis preferr ed Ability to develop and deliver presentatio ns Ability to communicate effectively in writing and verbal ly Ability to identify issues, present problems, and implement solutio ns Capability of communicating technical concepts clearly, concisely, and understandably to non-technical colleagu es Good leadership, organizational and time management skills, with the ability to multi-ta sk Strong interpersonal communication and presentation skil lsEducation Or Equivalent Experien ce A Master's degree in information and data science, operations research, mathematics, statistics, computer science or other related field, with focus in artificial intelligence preferred, and at least 7+ years of relevant professional experience or a Bachelor's degree with 10+ years of relevant professional experien ceBenefi tsWhy S DCSDC 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 industr y. 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 benefi ts We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitme nt We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture cl ub 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 indust ry With a proven track record, SDC has been successfully executing client clinical programs since 20 05Take a look at how you can join our tea m!