275 Sdtm Jobs

6-8 years of experience in Clinical Data Management/Clinical Data base programming or relevant field. Location: Mumbai Pune, Bangalore, Hyderabad, Kolkata Good technical experience on EDC systems (Rave/Veeva) Ability to provide technical expertise. Proactively communicate ownership of studies. Critical thinking to identify root causes and best practices. Knowledge of create high quality EDC specification. Knowledge of both SDTM and C-DASH (Clinical Data Acquisition Standards Harmonization) Knowledgeable of study protocols and create specifications that align to key deliverables. Knowledge of creation of Edit check specification and knowledge of programming edit check Knowledge of EDC design EDC edit check foundational standards library (Master specifications). Experience in setting eCRF in Rave/Veeva EDC Experience in programming FEC and simple edit checks To Apply share your cv to afreen@liveconnections.in Whatspp:8297161110

Hiring For: Multiple Leading MNCs Job Summary: We are hiring skilled and experienced SAS Clinical Programmers to join our global teams working with leading pharmaceutical companies and CROs. As a SAS programmer, you will be responsible for supporting clinical trial data analysis, CDISC implementation, and regulatory submissions across various therapeutic areas. Key Responsibilities: Develop, validate, and maintain SDTM and ADaM datasets , tables, listings, and figures (TLFs). Support clinical trial data analysis as per CDISC standards . Work closely with biostatisticians and data managers to ensure data quality and integrity. Write and validate SAS codes as per project and regulatory requirements. Prepare documentation for programming specifications and validation. Participate in project meetings, timelines discussions, and status updates. Qualifications: 5 to 10 years of hands-on experience in SAS programming in a clinical trial environment. Strong knowledge of CDISC standards (SDTM, ADaM &TFL) . Experience working on Safety & Efficacy Experience working with Phase I–IV clinical trials . Proficient in Base SAS, SAS/SQL, SAS/Macro . Familiarity with regulatory requirements (e.g., FDA, PMDA). Excellent problem-solving and communication skills. Preferred: Experience in working with global clients or MNCs. Exposure to tools like Pinnacle21, or other data review tools. Prior experience with submission-ready deliverables for FDA or EMA. What We Offer: Opportunities to work on global clinical trials with Tier-1 pharmaceutical clients. Competitive compensation and benefits. Flexible work models (remote/hybrid/on-site). Professional growth, training, and development support.

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY-Consulting - Data and Analytics – Senior - Clinical Integration Developer EY's Consulting Services is a unique, industry-focused business unit that provides a broad range of integrated services that leverage deep industry experience with strong functional and technical capabilities and product knowledge. EY’s financial services practice provides integrated Consulting services to financial institutions and other capital markets participants, including commercial banks, retail banks, investment banks, broker-dealers & asset management firms, and insurance firms from leading Fortune 500 Companies. Within EY’s Consulting Practice, Data and Analytics team solves big, complex issues and capitalize on opportunities to deliver better working outcomes that help expand and safeguard the businesses, now and in the future. This way we help create a compelling business case for embedding the right analytical practice at the heart of client’s decision-making. The opportunity We’re looking for Clinical Trials Integration Developers with 5+ years of experience in software development within the life sciences domain to support the integration of Medidata’s clinical trial systems across the Client R&D environment. This role offers the chance to build robust, compliant integration solutions, contribute to the design of clinical data workflows, and ensure interoperability across critical clinical applications. You will collaborate closely with business and IT teams, playing a key role in enhancing data flow, supporting trial operations, and driving innovation in clinical research. Your Key Responsibilities Design and implement integration solutions to connect Medidata clinical trial systems with other applications within the clinical data landscape. Develop and configure system interfaces using programming languages (e.g., Java, Python, C#) or integration middleware tools (e.g., Informatica, AWS, Apache NiFi). Collaborate with clinical business stakeholders and IT teams to gather requirements, define technical specifications, and ensure interoperability. Create and maintain integration workflows and data mappings that align with clinical trial data standards (e.g., CDISC, SDTM, ADaM). Ensure all development and implementation activities comply with GxP regulations and are aligned with validation best practices. Participate in agile development processes, including sprint planning, code reviews, testing, and deployment. Troubleshoot and resolve integration-related issues, ensuring stable and accurate data flow across systems. Document integration designs, workflows, and technical procedures to support long-term maintainability. Contribute to team knowledge sharing and continuous improvement initiatives within the integration space. Skills And Attributes For Success Apply a hands-on, solution-driven approach to implement integration workflows using code or middleware tools within clinical data environments. Strong communication and problem-solving skills with the ability to collaborate effectively with both technical and clinical teams. Ability to understand and apply clinical data standards and validation requirements when developing system integrations. To qualify for the role, you must have Experience: Minimum 5 years in software development within the life sciences domain, preferably in clinical trial management systems. Education: Must be a graduate preferrable BE/B.Tech/BCA/Bsc IT Technical Skills: Proficiency in programming languages such as Java, Python, or C#, and experience with integration middleware like Informatica, AWS, or Apache NiFi; strong background in API-based system integration. Domain Knowledge: Solid understanding of clinical trial data standards (e.g., CDISC, SDTM, ADaM) and data management processes; experience with agile methodologies and GxP-compliant development environments. Soft Skills: Strong problem-solving abilities, clear communication, and the ability to work collaboratively with clinical and technical stakeholders. Additional Attributes: Capable of implementing integration workflows and mappings, with attention to detail and a focus on delivering compliant and scalable solutions. Ideally, you’ll also have Hands-on experience with ETL tools and clinical data pipeline orchestration frameworks relevant to clinical research. Hands-on experience with clinical R&D platforms such as Oracle Clinical, Medidata RAVE, or other EDC systems. Proven experience leading small integration teams and engaging with cross-functional stakeholders in regulated (GxP) environments. What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

Job Title: Principal Programmer Statistical Programming Introduction To Role Are you ready to take on a pivotal role in statistical programmingAs a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers This is your chance to integrate statistical concepts with SAS Programming efficiently and effectively! Accountabilities Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards, Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications, Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP, Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications, Supervise/manage external vendors and contract programmers, Oversee progress of programming activities, Review, maintain, and approve protocol-specific documents as necessary, Provide guidance and mentoring to peer and junior-level Programmers, Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies, Contribute ideas and thoughts towards the optimization of standard operating procedures, Lead team meetings when appropriate, Any other activities as required, Essential Skills/Experience Bachelors Degree (Minimum) or Masters Degree (Preferred) in Biostatistics, Statistics or another related discipline Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry, Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs, Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT, Knowledge of SAS/Graph, and SAS/SQL Knowledge of: SDTM and ADaM Relational Databases, Good Clinical Practices, Good Programming Practices, 21CFR Part 11 Standards, Integrated Summary Safety/Efficacy Analyses, Safety data and Coding Dictionaries (MedDRA and WHODD), ICH eCTD format, At AstraZeneca, we play an essential role in helping patients who need it the most Our high exposure roles allow us to shape end deliverables while embracing global opportunities across all Therapy Areas With a restless drive for improvement, we foster an inspiring learning environment where every setback is a chance to innovate Our courageous team speaks up, shares opinions, and makes bold decisions that could change patients' lives We combine specialist knowledge with curiosity, always searching for better ways to achieve the best results Here, dedication and motivation are key as we navigate unknowns with resilience, Ready to make an impactApply now to join our dynamic team! Date Posted 11-Jul-2025 Closing Date 30-Jul-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law Alexion provides reasonable accommodations to meet the needs of candidates and employees To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion Alexion participates in E-Verify, Show

The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. The preferred candidate for this position should hold certification in clinical data management (like CCDM) and possess knowledge of CRF design, MS Project, and analytical capabilities. Familiarity with CDISC standards and data interchange formats such as SDTM and ADaM is beneficial. Basic knowledge of regulatory guidelines like FDA/CFR, ICH/GCP, understanding of data privacy and protection regulations (e.g., GDPR), and effective communication and interpersonal skills are essential to collaborate effectively with other teams. This role offers the opportunity to contribute to the advancement of clinical data management practices and maintain high standards of data quality in compliance with regulations and protocols.,

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for SDTM ProgrammingStatistical ProgrammingPython (Programming Language)Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersClinical EDC Design Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE

Role : Statistical Programmer – SDTM (End-to-End) Location: Remote Experience: 4+ Years Job Description: We are hiring a Statistical Programmer with 4+ years of experience in end-to-end SDTM programming , including specification creation and SDRG preparation . Key Responsibilities: Develop and validate SDTM datasets in compliance with CDISC standards Interpret mapping specifications and raw data Prepare the Study Data Reviewer's Guide (SDRG) Collaborate with global clinical teams and statisticians Maintain documentation and ensure submission compliance Requirements: 4+ years of hands-on SDTM programming experience Proficient in SAS and CDISC implementation Strong knowledge of clinical trial data and regulatory standards Excellent attention to detail and communication skills

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com. Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have The Clinical Data Programming Lead is responsible for guiding a team of programmers, overseeing database development, and ensuring compliance with industry standards. Key Responsibilities Lead a team of clinical data programmers, providing technical guidance and mentorship. Oversee database development, validation, and programming activities. Ensure timely delivery of data programming tasks and troubleshoot issues. Collaborate with cross-functional teams (Data Management, Biostatistics, IT) to streamline data workflows. Monitor compliance with CDISC, SDTM, and regulatory guidelines. Provide technical training to team members and ensure process improvements. Desired Profile: 5-7 years of experience in clinical data programming. Strong leadership skills with experience in team management. Expertise in EDC systems, SQL, SAS, R, Python, and CDISC (SDTM/ADaM). Excellent stakeholder management and problem-solving abilities. Good to have EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations : Bangalore, KA, IN

Key Responsibilities Develop and maintain R programs for generating CDISC SDTM and ADaM datasets and tables, listings, and figures in accordance with clinical trial data requirements Ensure compliance with industry standards and regulatory requirements Collaborate with cross-functional teams to understand and implement project-specific data needs Provide technical expertise and support for data analysis and reporting tasks Perform quality control and validation of outputs to ensure accuracy and consistency Qualifications Bachelor's degree in a quantitative field (e.g., Statistics, Mathematics, Computer Science, Data Science) Minimum of 3 years of experience in R programming including familiarity with R packages used in the analysis and reporting of data for clinical trials Familiarity with data visualization techniques and tools in R Experience with clinical trial data and familiarity with CDISC ADaM and SDTM standards Strong analytical and problem-solving skills Excellent communication and ability to work in a team environment Desirable Skills Knowledge of other open-source packages and tools Experience with SAS software Familiarity with CRAN, POSIT, and other open-source repositories and products Learn more about our EEO & Accommodations request here.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager - Clinical Data Hub Team What You Will Do Let’s do this. Let’s change the world. In this vital role you will lead an Agile product squad and responsible for defining the vision & strategy and implementation for a range of Clinical Data products supporting Amgen Clinical Trial Design & Analytics. You will collaborate closely with statisticians, data scientists, data engineers, and AI/ ML engineers teams to understand business needs, identify system enhancements, and drive system implementation projects. Your extensive experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. Roles & Responsibilities : Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and collaborators Collaborate with collaborators to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Assure that AIN team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Oversee the resolution of service-related incidents and problems, ensuring minimal impact on business operations Maintains in-depth knowledge of clinical development business domains with an emphasis in data assets and data pipelines, as well as an understanding of the multi-functional dependencies. Analyze customer feedback and support data to identify pain points and opportunities for product improvement What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years of experience in Computer Science, IT or related field of experience A solid foundation in modern software design and engineering practices and business analysis. Proven experience in undemanding and gather business requirements and delivered insight, and achieved concrete business outcome. Technical Proficiency: Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services ( EC2, S3, Lambda, ECS, IAM), Docker and CI/CD/Gitlab, Apache/Databricks, Expert understanding and experience of clinical development process within Life Sciences (global clinical trial data sources, SDTM & AdaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance) Experience in Agile product development as a participating member of a scrum team and related ceremonies and processes Ability to collaborate with data scientists and data engineers to deliver functional business requirements as well defining product roadmap. High learning agility, demonstrated ability of quickly grasp ever changing technology and clinical development domain knowledge and applied to the project work. Strong communications skills in writing, speaking, presenting and time management skills. Preferred Qualifications: Training or education degree in Computer Science, Biology, or Chemistry. Experience with Clinical Data and CDISC (SDTM and ADaM) standard Soft Skills: Excellent analytical and troubleshooting skills Deep intellectual curiosity, particularly about data patterns, and learning about business processes and “life of the user” Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing collaborator expectations Ability to work effectively with global, virtual teams, specifically including leveraging of tools and artifacts to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills; Ability to learn quickly and retain and synthesize complex information from diverse sources What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

J OB DESCRIPTION Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics.Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard EDUCATION AND EXPERIENCE REQUIRED Master's degree in Statistics or equivalent combination of Education and Experience (e.g. a Bachelors degree and at least 3 years of industry experience as a biostatistician) required A minimum of 3 years of experience as a statistician is required for the Senior Statistician position; a minimum of 1 year or EDETEK Training and supervisory approval is required for the non-Senior Statistician level Proficient in SAS and similar clinical data analysis software

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager - Clinical Data Hub Team What you will do Let’s do this. Let’s change the world. In this vital role you will lead an Agile product squad and responsible for defining the vision & strategy and implementation for a range of Clinical Data products supporting Amgen Clinical Trial Design & Analytics. You will collaborate closely with statisticians, data scientists, data engineers, and AI/ ML engineers teams to understand business needs, identify system enhancements, and drive system implementation projects. Your extensive experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. Roles & Responsibilities : Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and collaborators Collaborate with collaborators to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Assure that AIN team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Oversee the resolution of service-related incidents and problems, ensuring minimal impact on business operations Maintains in-depth knowledge of clinical development business domains with an emphasis in data assets and data pipelines, as well as an understanding of the multi-functional dependencies. Analyze customer feedback and support data to identify pain points and opportunities for product improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years of experience in Computer Science, IT or related field of experience A solid foundation in modern software design and engineering practices and business analysis. Proven experience in undemanding and gather business requirements and delivered insight, and achieved concrete business outcome. Technical Proficiency: Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services ( EC2, S3, Lambda, ECS, IAM), Docker and CI/CD/Gitlab, Apache/Databricks, Expert understanding and experience of clinical development process within Life Sciences (global clinical trial data sources, SDTM & AdaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance) Experience in Agile product development as a participating member of a scrum team and related ceremonies and processes Ability to collaborate with data scientists and data engineers to deliver functional business requirements as well defining product roadmap. High learning agility, demonstrated ability of quickly grasp ever changing technology and clinical development domain knowledge and applied to the project work. Strong communications skills in writing, speaking, presenting and time management skills. Preferred Qualifications: Training or education degree in Computer Science, Biology, or Chemistry. Experience with Clinical Data and CDISC (SDTM and ADaM) standard Soft Skills: Excellent analytical and troubleshooting skills Deep intellectual curiosity, particularly about data patterns, and learning about business processes and “life of the user” Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing collaborator expectations Ability to work effectively with global, virtual teams, specifically including leveraging of tools and artifacts to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills; Ability to learn quickly and retain and synthesize complex information from diverse sources What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Key Accountabilities: Project Management: Ability to fill Statistical Programming Lead role on projects Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Monitor project resourcing, project budgets, and identify changes in scope. Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells. Review database set-up specifications. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered in the conduct of their daily work. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supporting documents and submission documentation. Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas. Provide relevant training and mentorship to staff and project teams. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent PAREXEL at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness). Knowledge and Experience: Competent in written and oral English. Excellent communication skills. Education: Educated to degree level in a relevant discipline and/or equivalent work experience. #LI-REMOTE

Description Senior Statistical Programmer(SDTM + ADAM + TLF) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standardoperation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Require 8+ years of experience in Clinical SAS Programming, Base SAS, Advance SAS. Must have strong experience in SDTM, ADAM & TLF for Safety & efficacy data both. Require eSub experience. Must have study lead experience Excellent written and verbal communication skills. Ability to read, write, speak and understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing The role is part of the Submissions Center of Exellence Will need to keep informed of the latest regulatory requirements The programming of SDTM datasets, ADaM datasets, and TFLs will still be the responsibility of the trial clinical/statistical programmer Qualifications Previous experience submitting data to regulatory authorities is preferred Will take on the post-database lock activities related to making SDTM and ADaM data packages submission-ready (per latest requirements) Resizing datasets, removing empty variables etc. Generating Define.pdf o Final P21E run Verifying all explanations are correct in the cSDRG/ADRG o Bookmarking and setting correct properties for PDF documents o Etc What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment will be crucial, along with efficient debugging and utilization of standard macros. If you have experience with integrated summaries (ISS/ISE), it is considered a plus. The ideal candidate should possess 6 to 8 years of relevant experience in statistical programming, with a minimum of 3 years of hands-on experience in R programming. A strong working knowledge of CDISC standards such as SDTM, ADaM, and TLF is essential, along with exposure to efficacy analysis. Senior-level profiles should have experience in handling studies at the study level. Preferred skills for this role include familiarity with the CRT package (Trial Data Domain), previous involvement in ISS and ISE, experience in an FSP environment, and proficiency in standard macro debugging and utilization. In return, we offer a bootstrapped and financially stable environment with an above-industry renumeration package. Additional compensation is tied to Renewal and Pilot Project Execution, along with lucrative business development incentives. Our organization provides opportunities for firm building and holistic professional development, emphasizing empathy, excellence, and results. We believe in mentoring and nurturing our team members, with a continuous focus on learning and growth.,

Position Overview : We are seeking a skilled Statistical Programmer to join our clinical research team. The successful candidate will be responsible for programming, validating, and delivering statistical outputs for clinical trials while ensuring compliance with regulatory standards and industry best practices. Key Responsibilities : Programming & Data Management : - Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting. - Map clinical trial data to CDISC standards (SDTM and ADaM) ensuring compliance with regulatory requirements. - Create and maintain analysis datasets following CDISC implementation guidelines. - Perform data validation and quality control checks to ensure data integrity. Documentation & Compliance : - Generate and maintain CDISC documentation including define.xml files, reviewer's guides, and annotated case report forms (aCRF). - Conduct Pinnacle21 validation checks and resolve any compliance issues. - Ensure all deliverables meet regulatory submission standards (FDA, EMA, etc.). - Maintain comprehensive programming documentation and version control. Statistical Analysis & Reporting : - Produce Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans (SAP). - Collaborate with biostatisticians to implement complex statistical analyses. - Support clinical study reports and regulatory submissions. - Perform ad-hoc analyses as requested by clinical teams. Cross-functional Collaboration : - Work closely with clinical data management, biostatistics, and regulatory affairs teams. - Participate in project meetings and provide technical expertise. - Support timeline planning and deliverable tracking. - Mentor junior programmers and provide technical guidance. Required Qualifications : Technical Skills : - Minimum 3+ years of experience as a statistical programmer in clinical research or pharmaceutical industry. - Advanced SAS programming skills with expertise in Base SAS, SAS/STAT, SAS/GRAPH, and SAS Macro language. - Strong understanding of clinical trials including study designs, endpoints, and regulatory requirements. - Proven experience with CDISC standards (SDTM and ADaM) and data mapping techniques. - Experience with CDISC documentation including define.xml, reviewer's guides, and aCRF preparation. - Hands-on experience with Pinnacle21 validation software and resolving compliance issues. - Demonstrated ability to produce TLFs based on Statistical Analysis Plans with attention to detail. Soft Skills : - Fluent in English with excellent written and verbal communication skills. - Strong problem-solving mentality with ability to troubleshoot complex technical issues. - Detail-oriented approach with commitment to accuracy and quality. - Excellent communication and interpersonal skills for effective team collaboration. - Fast learner with ability to adapt to new technologies and methodologies. - Strong organizational skills and ability to manage multiple priorities. Preferred Qualifications (Nice to Have) : - Real-World Data (RWD) experience including analysis of electronic health records, claims data, or registries. - Pharmacokinetic (PK) calculations experience and understanding of PK/PD modeling. - R programming skills for statistical analysis and data visualization. - Experience with other statistical software packages (Python, SPSS, etc.). - Knowledge of therapeutic areas and regulatory guidelines. - Experience with cloud-based platforms and version control systems. Education Requirements : - Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field. - Advanced degree preferred but not required with relevant experience. This position offers an excellent opportunity for a skilled statistical programmer to contribute to meaningful clinical research while developing expertise in regulatory compliance and industry best practices.

About The Job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities The Biostatistician will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts); The Biostatistician will ensure SOPs are followed and timelines and quality metrics are met. People Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process Conduct appropriate post-hoc statistical analyses of clinical trial data. Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. Produce well documented data packages that include tables, listings, and figures. Closely follow QC plans and timelines set by senior members of the Sanofi Global Hub biostatistics and programming team. Review appropriate biomedical and clinical research literature related to assigned project(s). Customer Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. About You Experience : Master's degree with 3-6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 2-3 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology. Languages : Excellent English language knowledge – written and spoken Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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! #LI-Hybrid

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis. Primary Responsibilities Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams Review the Statistical Analysis Plan in preparation for programming the planned analyses Lead design/development of SAS macros and other utilities to expedite SAS programming activities Organize and conduct internal training sessions and author papers for conferences Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request Participate in statistical program validation and quality control activities Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines Develop define.xml, study data reviewers guide and analysis datasets reviewers guide Identify study priorities and communicate effectively with project team and management Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours Manage statistical programming timelines, budgets, and client expectations Actively participate in study team meetings Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management Program data cleaning checks, as necessary, to assist Data Management’s data cleaning activities Participate in installation/validation of statistical software packages throughout the software development lifecycle Develop and maintain the infrastructure for project files of SAS datasets and SAS code Mentor junior level statistical programmers by developing training plans and providing oversight of their work Ensure all programming activities and processes performed are conducted according to SDC’s standard procedures and/or sponsor requirements Adhere to all aspects of the SDC’s quality system Comply with SDC’s data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills Strong analytical skills, with the ability to process scientific and medical data. Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS Macros and SAS/Graph Strong problem-solving skills Able to work independently Excellent knowledge of statistical programming Proficient in manipulating and analyzing SAS data Ability to identify data issues, present problems, and implement solutions quickly Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues Good organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models Very strong interpersonal communication, presentation, and leadership skills SAS Base, Advance and Clinical Trials Certification is preferred Education or Equivalent Experience Bachelor’s degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience. Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry. We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

Senior Statistical Programmer I 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! #LI-Hybrid

About the job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) ;The Senior Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Senior Statistical Programmer will ensure SOPs are followed and timelines and quality are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About you Experience : Master's degree minimum 4 years/B.Sc. minimum 6 years of relevant experience required Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge – written and spoken Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: The Biostatistician will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC’d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts); The Biostatistician will ensure SOPs are followed and timelines and quality metrics are met. People: Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product – with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data. 2) Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS. 3) Produce well documented data packages that include tables, listings, and figures. 4) Closely follow QC plans and timelines set by senior members of the Sanofi Global Hub biostatistics and programming team. 5) Review appropriate biomedical and clinical research literature related to assigned project(s). Customer: Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables. About you Experience : Master's degree with 3-6 years (M.Sc.) of experience required /Ph.D. in biostatistics or statistics or epidemiology and 2-3 years. Soft skills : Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines. Technical skills : Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Education : Master of Science degree or equivalent in Statistics/ Ph.D. in biostatistics or statistics or epidemiology. Languages : Excellent English language knowledge – written and spoken Better is out there. Better medications, better outcomes, better science. But Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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!

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!