SDC (Statistics & Data Corporation)

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!

Senior Clinical Data Management Programmer 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 Leads in the evaluation, implementation and validation of package systems to support Clinical Database review requests of all Clinical Database applications. Creates, maintains and oversees process for providing end user support for all Data review and ad hoc listings. Works very closely with Clinical Data Managers to develop study specifications listings and gain acceptance through user testing. Develops data quality listings to comply with related specifications and regulatory requirements. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance, and company SOPs. Communicates programming and related document review statuses to management and the project teams. Primary Responsibilities Lead the development, validation, and maintenance of clinical reporting of clinical trials using a variety of validated software applications Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management documentation Develop a variety of SAS/Data review/Visualization reports by integrating various sources of Data for efficient Clinical Data review and decision making Implement and test data quality checks in accordance with the study database specification listings Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data) Serve as SME and facilitate integration of EDC systems to other clinical platforms such as CTMS, Reporting, and IRT as needed Assist in managing and providing listings to all medical coding dictionaries, including but not limited to MedDRA and WHODrug Oversee the management of Clinical report development, other GxP system user accounts and other help desk activities within Clinical reporting areas Develop EDC report listings, work with EDC vendors to resolve, and escalate issues appropriately to Senior Management Work very closely with other functions to support ad hoc report development using tools such as Python, R Programming, Power BI, etc Quickly learn new and/or advancements in software to become the SME for any technical question Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance) Keep management team abreast of issues, progress, and risks related to trial operations Support bid defenses from a technical SME perspective Providing proactive ideas, support developing Insightful reports for supporting Data review process, Participate in other clinical programming and data management activities, as required Participate in internal and external team meetings, as required Mentor junior level clinical programmers 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 with 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 Excellent understanding of relational database structures Fast, accurate programming skills using assorted application software SAS, R Programming, Python, PL/SQL, SQL, and XML programming skills Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships Demonstrated ability to provide both "user-friendly" and technical documentation Good time management and organization skills, including the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work Ability to provide expertise to guide department in continued efficiency and growth Knowledge of FDA regulations and guidance (e.g., 21 CFR Part 11, ICH/GCP) Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment Good knowledge of industry standard EDC tools (Medidata Rave, iMedNet, Viedoc, Veeva, etc.) Knowledge of Reporting application development (e.g., JReview, Business Objects, Python, PowerBI) is required Education Or Equivalent Experience Bachelor's degree in computer science or other quantitative or scientific discipline with 6+ years' experience in database programming and demonstrated working knowledge of scientific principles At least 6 years' experience assuming lead report programming responsibilities on projects, with a minimum of 4 years in a clinical environment Experience with FDA regulations and guidance is required 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!

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 Performs data management activities in support of clinical research studies that includes review of clinical data, external vendor supplied clinical data, laboratory data, serious adverse event data, unexpected adverse device events, query management (identification, generation, resolution review and close-out). Primary Responsibilities Track and maintain audit-ready clinical study documentation in support of data and listing reviews within the electronic and/or hard copy Trial Master Files for multiple projects Perform data entry and query management including data listing review, query creation and resolution Perform study related activities within budgeted time Work with QC and QA teams to make the internal TMF ready for study deliverables in regard to data review, reconciliation and listing documentation Perform study conduct activities including, but not limited to Query Management, Listing Review Perform 3rd party reconciliation and SAE reconciliation as assigned Adhere to all aspects of SDC's quality system Comply with SDC's data integrity & 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 Requirements Required Skills Basic proficiency with Microsoft Word and Excel software Ability to work well in a team environment Excellent organizational skills and attention to detail Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities Effective communications skills both written and verbal Possess strong problem-solving skills, be solution-oriented Additional desired skills might include any of the following{​{:}} medical terminology, familiarity with relational databases/electronic data capture systems; clinical research coordinator experience; working knowledge of clinical trials and Data Management's role in the clinical trials proces sEducation Or Equivalent Experienc e Bachelor's degree, preferably in applied or life science, and at least 3 years work experienc eBenefit sWhy SD CSDC 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 benefit s We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitmen t We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture clu b 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 industr y With a proven track record, SDC has been successfully executing client clinical programs since 200 5Take a look at how you can join our team !

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!

Statistics & Data Corporation (SDC) is a specialized contract research organization (CRO) based in Arizona, offering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC provides technology-enabled services to equip clients with the necessary clinical services expertise and technology for successful clinical trials. As a Statistical Programmer at SDC, your primary responsibility will be to provide statistical programming support for clinical trials. This includes generating and validating analysis datasets, tables, listings, and figures for clinical trials, creating SDTM mapping and datasets, and maintaining the infrastructure for project files of SAS datasets and SAS code. You will collaborate with Data Management on data set creations/transfers, integrity checks, and quality audits, and act as a liaison between clinical subcommittees and project teams as needed. Key responsibilities include: - Performing statistical programming for clinical trial analysis and reporting on large-scale, complex projects - Applying appropriate statistical methods for data analysis and providing expertise to project teams - Leading the design and development of SAS macros and utilities to expedite programming activities - Generating tables, listings, and figures per protocol and client requests - Reviewing reports for compliance with CDISC and FDA guidelines - Developing documentation and study data reviewers guides - Managing programming timelines, budgets, and client expectations - Mentoring junior statistical programmers and ensuring compliance with standard procedures and sponsor requirements Required skills for this role include strong analytical skills, proficiency in SAS programming (SAS/Base, SAS/Stat, SAS Macros, and SAS/Graph), problem-solving abilities, and the capability to work independently. You should also have excellent knowledge of statistical programming, the ability to communicate technical concepts clearly, and familiarity with clinical trial design and regulatory guidelines. To qualify for this position, you should have a Bachelor's degree in computer science, statistics, or a related field, along with at least eight years of relevant professional experience. Certification in SAS Base, Advanced, and Clinical Trials is preferred. At SDC, we are committed to developing our employees, offering growth opportunities, career advancement, a flexible work schedule, and engaging work culture. Our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment are central to our recognition program. Join our team to be part of a dynamic and innovative organization that supports both client and employee needs in the clinical research industry.,

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. 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 and SAS Macros Basic understanding of 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 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 Strong interpersonal communication and presentation 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 six 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!

Statistics & Data Corporation (SDC) is a specialized contract research organization (CRO) based in Arizona, dedicated to providing top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC offers a technology-enabled service to clients, combining clinical services expertise with the necessary technology for successful clinical trials. As a Data Management Specialist at SDC, you will be responsible for various data management activities in support of clinical research studies. This includes reviewing clinical data, external vendor supplied clinical data, laboratory data, serious adverse event data, unexpected adverse device events, and managing queries effectively. Your primary responsibilities will include tracking and maintaining audit-ready clinical study documentation, performing data entry and query management, ensuring study-related activities are completed within budgeted time, collaborating with QC and QA teams to prepare the Trial Master Files for study deliverables, conducting study-related activities such as Query Management and Listing Review, as well as performing 3rd party reconciliation and SAE reconciliation as required. It is essential to adhere to SDC's quality system, comply with data integrity and business ethics requirements, and follow all essential systems and processes to maintain compliance with business and regulatory standards. To excel in this role, you must possess basic proficiency in Microsoft Word and Excel, work effectively in a team environment, have excellent organizational skills with attention to detail, be able to work on multiple projects simultaneously, prioritize tasks efficiently, communicate effectively both in writing and verbally, demonstrate strong problem-solving skills, and be solution-oriented. Additional desired skills may include knowledge of medical terminology, familiarity with relational databases/electronic data capture systems, experience as a clinical research coordinator, and an understanding of Data Management's role in clinical trials. The ideal candidate should hold a Bachelor's degree, preferably in applied or life science, and have a minimum of 3 years of relevant work experience. Joining the team at SDC offers numerous benefits, including opportunities for professional development, career advancement, flexible work schedules, engaging work culture, and employee benefits. The company is dedicated to recognizing achievements, promoting growth, and fostering a sense of belonging through fun and engaging activities. SDC is committed to innovation and growth, supporting both client and employee needs in this dynamic industry. If you are looking to be part of a team that values energy, integrity, engagement, innovation, ownership, and commitment, consider joining SDC and contribute to our continued success in executing client clinical programs.,

As a Statistical Programmer at Statistics & Data Corporation (SDC), a reputable contract research organization based in Arizona, you will be responsible for providing statistical programming support for clinical trials. Your primary role will involve producing statistical analyses, generating and validating analysis datasets, tables, listings, and figures for clinical trials. You will be required to create SDTM mapping and datasets, develop and maintain project files of SAS datasets and SAS code, and support Data Management in various data-related tasks. Additionally, you will act as a liaison between clinical subcommittees and project teams as needed. Your responsibilities will include overseeing statistical programming activities for medium to large-scale projects, applying appropriate statistical methods for data analysis, and providing statistical programming expertise to project teams. You will review the Statistical Analysis Plan, lead the development of SAS macros and utilities, and conduct internal training sessions. Furthermore, you will be responsible for generating tables, listings, and figures as per protocol requirements, participating in statistical program validation activities, and developing SDTM and ADaM datasets. You will also ensure compliance with CDISC and FDA guidelines, develop define.xml and study data reviewer's guides, and communicate effectively with project teams and management. In addition to the technical aspects of the role, you will play a key role in mentoring junior statistical programmers, managing programming timelines and budgets, and ensuring adherence to SDC's standard procedures and quality system. Strong analytical and problem-solving skills, proficiency in SAS programming, and knowledge of regulatory guidelines are essential for this position. To qualify for this role, you should possess a Bachelor's degree in computer science, statistics, or a related scientific field, along with at least six years of relevant professional experience. Certification in SAS Base, Advance, and Clinical Trials is preferred. At SDC, we are committed to the growth and development of our employees, providing a flexible work schedule, engaging work culture, and career advancement opportunities. Our company culture is centered around core values such as Energy, Integrity, Engagement, and Innovation. Join our team and be part of a dynamic and innovative organization that is dedicated to supporting both our clients and employees in this ever-evolving industry.,

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!

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 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 all statistical programming required for clinical trial analysis and reporting 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 Design/develop SAS macros and other utilities to expedite SAS programming activities 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 SDTM aCRF and specifications; complete programming and validation of CDISC SDTM and ADaM datasets Review ADaM specification documents and ensure the specifications meet the analysis criteria specified in the SAP 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 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 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 and SAS Macros Basic understanding of 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 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) Solid understanding of CDISC SDTM and ADaM data models Strong interpersonal communication and presentation skills Education Or Equivalent Experience Bachelor's degree in computer science, statistics or other related, scientific field and four 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!

You will be responsible for providing statistical programming support to clinical trials at Statistics & Data Corporation (SDC), a specialized contract research organization headquartered in Arizona. Since 2005, SDC has been delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies. As part of a technology-enabled service offering, you will contribute to both clinical services expertise and technological support required for successful clinical trials. Your primary responsibilities will include performing all statistical programming necessary for clinical trial analysis and reporting. You will apply appropriate statistical methods for data analysis, review Statistical Analysis Plans, and design/develop SAS macros and utilities to streamline programming activities. Additionally, you will generate tables, listings, and figures per protocol and client requests, participate in program validation and quality control activities, and develop SDTM and ADaM datasets. You will collaborate with various departments such as Clinical Operations, Project Management, and Data Management to ensure high client satisfaction through successful project execution. Your role will also involve mentoring junior statistical programmers, maintaining project files, adhering to quality systems, and complying with data integrity and business ethics requirements. To be successful in this role, you must possess strong analytical skills, proficiency in SAS programming (including SAS/Base, SAS/Stat, and SAS Macros), and a basic understanding of SAS/Graph. You should have a solid grasp of statistical programming, the ability to identify and resolve data issues, and excellent communication skills to convey technical concepts clearly to non-statistical colleagues. Familiarity with clinical trial design, regulatory guidelines, and CDISC SDTM and ADaM data models is essential. Ideally, you should hold a Bachelor's degree in computer science, statistics, or a related scientific field, along with four years of relevant professional experience. SDC offers a supportive work environment that values employee development, growth opportunities, career advancement, flexible work schedules, an engaging culture, and various benefits. Join SDC's dynamic team and contribute to the successful execution of client clinical programs while being part of a company that fosters innovation, growth, and a sense of belonging among its employees.,

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 Performs data management activities in support of clinical research studies that includes review of clinical data, external vendor supplied clinical data, laboratory data, serious adverse event data, unexpected adverse device events, query management (identification, generation, resolution review and close-out). Primary Responsibilities Track and maintain audit-ready clinical study documentation in support of data and listing reviews within the electronic and/or hard copy Trial Master Files for multiple projects Perform data entry and query management including data listing review, query creation and resolution Perform study related activities within budgeted time Work with QC and QA teams to make the internal TMF ready for study deliverables in regard to data review, reconciliation and listing documentation Perform study conduct activities including, but not limited to Query Management, Listing Review Perform 3rd party reconciliation and SAE reconciliation as assigned Adhere to all aspects of SDC&aposs quality system Comply with SDC&aposs data integrity & 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 Requirements Required Skills Basic proficiency with Microsoft Word and Excel software Ability to work well in a team environment Excellent organizational skills and attention to detail Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities Effective communications skills both written and verbal Possess strong problem-solving skills, be solution-oriented Additional desired skills might include any of the following?: medical terminology, familiarity with relational databases/electronic data capture systems; clinical research coordinator experience; working knowledge of clinical trials and Data Management&aposs role in the clinical trials proces sEducation Or Equivalent Experienc e Bachelor&aposs degree, preferably in applied or life science, and at least 3 years work experienc eBenefit sWhy SD CSDC 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 benefit s We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitmen t We strive to provide a place of belonging to our employees with fun and engaging activities from SDC&aposs culture clu b 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 industr y With a proven track record, SDC has been successfully executing client clinical programs since 200 5Take 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 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&aposs quality system Comply with Statistics & Data Corporation&aposs 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&aposs 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&aposs 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 Business Operations Associate primary responsibilities include supporting Business Operations by creating, maintaining, and updating documentation and information across all business systems in support of the request for information (RFI), Work Order (WO), and Work Order Amendment (WOA) lifecycle. Business Operations Associates will also assist with analyzing, preparing, and maintaining reports and dashboards for metrics and tracking. These tasks need to be accomplished on time with quality and in a professional manner that indicates great attention to detail. Primary Responsibilities Create and maintain reports and dashboards in the client relationship management system. Support with the development and programming of approved changes/enhancements within the client relationship management system. Support and maintain project management system and the client relationship management system process documentation. Create and maintain opportunities in the client relationship management system throughout the opportunity lifecycle. Create and maintain required folders on the Business Operations drive and ensure that all required documents are saved and maintained (e.g., opportunity documents, proposals, WO, WOA, etc.) Draft the following for Business Operations senior review{​{:}} Responses to Partner/Sponsor Requests for Information (RFI) from the content management system. Upload and maintain final approved responses to RFIs to the content management system. Proposal, Work Orders (WO), and Work Order Amendment (WOA) documents. Sales Orders (SO) for processing in the client relationship management system and financial syste mSupport WO setup and WOA processing activities in the project management and finance systems. Run and analyze defined reports from the project management system and the client relationship management system to support project scope management. Prepare the High Probability Billing Milestone forecast and share with Business Development and Accounting. Align with Accounting on New Authorization amount sEscalate any risks or issues to department management. Perform other duties as assigned. Support continuous improvement initiatives as defined by department management. Comply with Statistics & Data Corporation's data integrity & business ethics requirements. Adherence to all essential systems and processes that are required at SDC to maintain compliance with 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 classifie dRequirement sRequired Skill sStrong knowledge and demonstrated ability to develop, build, and program in Salesforce Exceptional quality and on time delivery Excellent verbal and written communication skills Exceptional organization and planning skills Excellent prioritization and time management abilities Good analytical and problem-solving skills to include excellent ability to identify and resolve problems early Solid independent, critical thinking ability and demonstrated ability to work autonomously with minimum supervision on defined tasks Keen ability to accurately discern priorities in a resource constrained work environment Exceptional customer service skills Excellent computer skills to include strong knowledge and MS Office suite of softwar eFamiliarity with ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulation sEducation Or Equivalent Experienc eA bachelor's degree, preferably in engineering, applied or life sciences or business is required. Two years of experience in business development, account management, contracts management, project or purchasing in the clinical trial industry is preferred. Salesforce Certified Administrator is required. Salesforce Certified Platform App Builder is preferre dBenefit sWhy SD CSDC 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 benefit s We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitmen t We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture clu b 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 industr y With a proven track record, SDC has been successfully executing client clinical programs since 200 5Take a look at how you can join our team !

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 Business Operations Associate primary responsibilities include supporting Business Operations by creating, maintaining, and updating documentation and information across all business systems in support of the request for information (RFI), Work Order (WO), and Work Order Amendment (WOA) lifecycle. Business Operations Associates will also assist with analyzing, preparing, and maintaining reports and dashboards for metrics and tracking. These tasks need to be accomplished on time with quality and in a professional manner that indicates great attention to detail. Primary Responsibilities Create and maintain reports and dashboards in the client relationship management system. Support with the development and programming of approved changes/enhancements within the client relationship management system. Support and maintain project management system and the client relationship management system process documentation. Create and maintain opportunities in the client relationship management system throughout the opportunity lifecycle. Create and maintain required folders on the Business Operations drive and ensure that all required documents are saved and maintained (e.g., opportunity documents, proposals, WO, WOA, etc.) Draft the following for Business Operations senior review?: Responses to Partner/Sponsor Requests for Information (RFI) from the content management system. Upload and maintain final approved responses to RFIs to the content management system. Proposal, Work Orders (WO), and Work Order Amendment (WOA) documents. Sales Orders (SO) for processing in the client relationship management system and financial syste mSupport WO setup and WOA processing activities in the project management and finance systems. Run and analyze defined reports from the project management system and the client relationship management system to support project scope management. Prepare the High Probability Billing Milestone forecast and share with Business Development and Accounting. Align with Accounting on New Authorization amount sEscalate any risks or issues to department management. Perform other duties as assigned. Support continuous improvement initiatives as defined by department management. Comply with Statistics & Data Corporation&aposs data integrity & business ethics requirements. Adherence to all essential systems and processes that are required at SDC to maintain compliance with 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 classifie dRequirement sRequired Skill sStrong knowledge and demonstrated ability to develop, build, and program in Salesforce Exceptional quality and on time delivery Excellent verbal and written communication skills Exceptional organization and planning skills Excellent prioritization and time management abilities Good analytical and problem-solving skills to include excellent ability to identify and resolve problems early Solid independent, critical thinking ability and demonstrated ability to work autonomously with minimum supervision on defined tasks Keen ability to accurately discern priorities in a resource constrained work environment Exceptional customer service skills Excellent computer skills to include strong knowledge and MS Office suite of softwar eFamiliarity with ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulation sEducation Or Equivalent Experienc eA bachelor&aposs degree, preferably in engineering, applied or life sciences or business is required. Two years of experience in business development, account management, contracts management, project or purchasing in the clinical trial industry is preferred. Salesforce Certified Administrator is required. Salesforce Certified Platform App Builder is preferre dBenefit sWhy SD CSDC 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 benefit s We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitmen t We strive to provide a place of belonging to our employees with fun and engaging activities from SDC&aposs culture clu b 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 industr y With a proven track record, SDC has been successfully executing client clinical programs since 200 5Take 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 Manager, Business Development Operations responsibilities include working with Business Development, Operational Logistics / Project Management, Accounting, Quality Assurance, Operations, and clients/partners to oversee processes and personnel responsible for the preparation of proposals with associated pricing, Confidential Disclosure Agreements, Master Service Agreements, Work Orders and Work Order Amendments that are responsive to client/partner needs. Coordinate the status of this work internally and with the external client/sponsor as appropriate, in a timely, professional manner with high attention to detail. Interface with partners/clients (indirectly via Sales Lead when applicable) on all account matters and be familiar enough with their contractual requirements to help identify and understand customer relations issues along with related project risks and identify corrective action and risk mitigation plans as required. Coordinate with Senior Vice President (SVP), Business Development to ensure that Executive Management are immediately notified of any and all client/sponsor issues that are thought to be significant (e.g., service complaints, invoicing problems, etc.) along with recommendations for resolution. Primary Responsibilities Provide management oversight and training to all direct reports within the Business Development team Support SVP, Business Development in coordinating with Accounting, Operational Logistics / Project Management, and Business Development to prepare, maintain, and regularly communicate a forecast for all new business to include scope of work and project/contract timing Support Sales Lead to coordinate with prospective and current clients/partners to understand the scope of work requirements for all new candidate projects and/or changes to current projects and prepare initial pricing and proposals that are responsive to the request Review draft pricing and proposals as needed with SVP, Business Development Coordinate with Business Development team to ensure that all contracts, proposals, and other opportunities are updated and maintained via all available Business Development resources (Salesforce.com, KeyedIn, etc.) Oversee the preparation of Confidential Disclosure Agreements (CDAs), Master Service Agreements (MSAs), and associated Work Orders and Work Order Amendments Develop/maintain Business Development Operations processes Proactively identify and coordinate with Business Development on resolution of problems/issues that may jeopardize winning new business Ensure project scope of work, deliverable requirements, and project budgets are well coordinated with internal staff, helping to identify and communicate contract scope creep as early as possible Coordinate with Accounting and operational departments to ensure all billing milestones are identified, tracked, and regularly reviewed Communicate with support staff in a positive, proactive manner to ensure team objectives are met Coordinate with SVP, Business Development to discern when to involve executive management to help reconcile problems/issues with internal staff members and/or clients/sponsors Ensure the quality of all Business Development Operations deliverables prior to submission to clients/partners Coordinate with SVP, Business Development, or other Executive Leadership to determine when outside legal review of documents is required Support continuous improvement initiatives spearheaded by executive management and/or department heads Comply with Statistics & Data Corporation's data integrity & business ethics requirements Perform other duties as assigned Adherence to all essential systems and processes that are required at SDC to maintain compliance with 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 Exceptional customer support skills Excellent understanding of contracts and demonstrated ability to manage contracts Ability to instill and maintain confidence in customer base Excellent leadership and management abilities Strong ability to motivate company personnel to meet project requirements within budget Solid independent, critical thinking ability and demonstrated ability to discern multiple viewpoints Familiarity with ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Good analytical and problem-solving skills to include excellent ability to identify and resolve problems early Keen ability to accurately discern individual and team priorities in a fast-paced work environment Solid understanding of SDC service and technology offerings and related processes Excellent verbal and written communication skills Excellent computer skills to include strong knowledge and MS Office suite and Saleforce.com Ability to travel up to 25% of the time as needed for meetings, industry conferences, etc Education Or Equivalent Experience A bachelor's degree, preferably in engineering, applied or life sciences or business is required Four (4) years of experience in business development, account management, contracts management, or purchasing in the clinical trial industry is required 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!

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 Lead in the evaluation, implementation, and validation of packaged systems. Create, maintain, and oversee processes for providing end user support in EDC systems. Build studies and support other users to build studies in EDC and other GxP systems. Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Actively promotes standards for the development and acquisition of, and serve as the SME for, GxP systems. Mentors/trains junior level clinical programmers. Primary Responsibilities Lead the development, validation, and maintenance of clinical databases for clinical trials using a variety of validated software applications Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans Develop and maintain global library of clinical database forms, edit checks, and other regularly used programs and routines Implement and test data quality checks in accordance with the study data validation manual Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data) Serves as SME and facilitates integration of EDC systems to other clinical platforms such as CTMS, Reporting, IRT as needed Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug Oversee the management of EDC, other GxP system user accounts and other help desk activities Track issues in EDC systems, work with EDC vendors to resolve, and escalate issues appropriately to senior management Quickly learn new and/or advancements in software to become the SME for any technical question Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance) Exhibit good time management and organization skills; the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work Keep management team abreast of issues, progress, and risks related to trial operations Support bid defenses from a technical SME perspective Participate in other clinical programming and data management activities, as required Participate in internal and external team meetings, as required Mentor junior level clinical programmers Adhere to all aspects of the Statistics & Data Corporation&aposs quality system Comply with Statistics & Data Corporation&aposs data integrity & business ethics requirements Perform other related duties incidental to the work described herein 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 At least eight years' experience assuming lead database programming responsibilities on projects, with a minimum of 5 years in a clinical environment Excellent understanding of relational database structures Fast, accurate programming skills using assorted application software PL/SQL, SQL, and XML programming skills Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships Demonstrated ability to provide both "user-friendly" and technical documentation Ability to provide expertise to guide department in continued efficiency and growth Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP) Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment C#, C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge / experience not required, but desirable Medidata Rave and iMedNet EDC knowledge / experience not required, but desirable Reporting application development (e.g., JReview, Business Objects, PowerBI) knowledge / experience not required, but desirable Education Or Equivalent Experience Bachelor&aposs degree in computer science or other quantitative or scientific discipline with 8+ years' experience in database programming and demonstrated working knowledge of scientific principles Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree 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&aposs 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

As a Lead Statistician at Statistics & Data Corporation (SDC), you will apply your high level of technical expertise to guide and develop junior biostatistics staff members. You will serve as the lead statistician on clinical studies and provide senior-level peer review for work accomplished by other biostatisticians in the department. Your role will be crucial in maintaining the statistical and analytical integrity of clinical trials analyzed by SDC. Your responsibilities will include actively participating in various aspects of clinical studies such as writing statistical sections of protocols, preparing statistical analysis plans, interpreting analysis results, writing statistical sections of clinical study reports, and engaging in meetings with drug regulatory agencies when necessary. Additionally, you will support business development and project management by contributing to strategic planning, proposals, pricing, and timeline planning. Key responsibilities also include serving as an internal consultant for biostatistics analysis tools and methods, acting as a subject matter expert during client and vendor meetings, supporting business development in capabilities presentations, managing assigned clinical study budgets, coaching and mentoring junior staff, and serving as the lead statistician on clinical research projects. You will have the opportunity to provide statistical expertise for study design of clinical trial protocols, write statistical analysis plans, review CRFs for consistency with protocols, program summary tables and data listings, perform statistical QC of all department outputs, and provide statistical support to external clients. Moreover, you will contribute to the development, maintenance, and training of standard operating procedures and represent the biostatistics department at various meetings. To excel in this role, you must possess effective leadership skills, excellent analytical abilities, project management expertise, knowledge of statistical programming and SAS data manipulation, as well as strong communication and presentation skills. Your educational background should include a Master's degree in biostatistics, statistics, or a related scientific field, along with at least eight years of relevant professional experience. Joining our team at SDC means being part of a company that is committed to developing its employees, providing growth opportunities, career advancement, flexible work schedules, engaging work culture, and employee benefits. Our company culture values energy, integrity, engagement, innovation, ownership, and commitment. We offer a place of belonging with fun and engaging activities through SDC's culture club. With a proven track record since 2005, SDC continues to grow and innovate to support both client and employee needs. If you are looking to be a part of a dynamic team where your expertise in biostatistics can make a difference, consider joining Statistics & Data Corporation.,