275 Sdtm Jobs - Page 7

Job Description : As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose : The Statistical Programmer will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities : SAS Programming : You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy). CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications : MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.

Roles And Responsibilities: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate.

ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy •Develop and/or validate Tables, Listings, and Figures using SAP and mock shells •Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards •Ability to work independently and as part of a team environment •Provide the status of assigned tasks to the Study Lead Programmer •Actively participating in the study meetings and support as backup lead •Identify, communicate, and manage study-based risks and issues within the timeframe •Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance •Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines •Provide guidance, mentoring, and training for junior team members as appropriate

PRINCIPAL STATISTICAL PROGRAMMER (12 15 YEARS) LOCATION: ANYWHERE IN INDIA WORK MODE : HYBRID ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion

Roles And Responsibilities: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion.

Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis results To ensure that the assigned team members are in compliance with SOPs and training requirements.

Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. As an ISO-certified organization and partner of Medidata Rave, we are committed to excellence and trust in clinical research. We are seeking a highly motivated and skilled Clinical Statistical Programmer to join our dynamic Biometrics team. In this role, you will be instrumental in the development, validation, and maintenance of programs used for the analysis and reporting of clinical trial data. You will work closely with biostatisticians, data managers, and clinical scientists to ensure the accurate and timely delivery of high-quality statistical outputs. Responsibilities: Develop, validate, and maintain SAS programs for the creation of SDTM and ADaM datasets, tables, listings, and figures (TLFs) according to statistical analysis plans (SAPs) and programming specifications. Ability to contribute to the development and implementation of Statistical Analyses Plan Perform quality control (QC) of programs and outputs generated by other statistical programmers to ensure accuracy, consistency, and adherence to company standards and regulatory guidelines. Collaborate with biostatisticians to clarify programming requirements, resolve data issues, and ensure the accurate implementation of statistical methodologies. Contribute to the development and review of programming specifications, mock TLFs, and other study-related documentation. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and internal Standard Operating Procedures (SOPs). Participate in team meetings and contribute to discussions regarding study design, data analysis, and reporting strategies. Proactively identify and implement process improvements to enhance efficiency and quality of programming deliverables. Maintain comprehensive documentation of programming activities and version control. May contribute to the development and maintenance of programming standards and macros. Qualifications: Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific field. Minimum of3] years of experience in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro Language). Strong understanding of CDISC standards, including SDTM and ADaM. Experience with regulatory submissions (e.g., NDA, BLA) is highly desirable. Solid understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements. Excellent attention to detail and strong problem-solving skills. Ability to work independently and as part of a collaborative team. Strong written and verbal communication skills. Experience with other programming languages (e.g., R, Python) is a plus. Knowledge of industry best practices for statistical programming. What We Offer: Opportunity to work on innovative clinical trials across diverse therapeutic areas. A collaborative and supportive work environment. Opportunities for professional growth and development. Competitive salary and benefits package. Show more Show less

The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs. The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero's standard operating procedures (SOPs) and processes. More specifically, the Senior Statistical Programmer must: Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. Act as a Lead Statistical Programmer on multiple single studies. Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells. Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Indero and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Indero and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Indero and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs. Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables. Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes. Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. May also: Mentor more junior Statistical Programmers. Requirements: Education Bachelor’ degree in Statistics, Computing Sciences or a related field; Master’s degree an asset Experience At least 7 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer. Knowledge And Skills Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. Excellent working knowledge of SAS; SAS certification an asset. Knowledge of XML programming an asset. Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. Very organized and detail-oriented, with effective project planning and time management skills. Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English; Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India. Show more Show less

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Coordinate communication and issues with Data Management regarding database specifications and data transfers Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field SAS Ceritifcation SAS knowledge required and 1 to 2 years' experience is preferred Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Provide support to project teams on programming matters; Manage programming staff, coordinate task assignments and review activities/progress to ensure high quality delivery; Provide leadership and training for the Programming group; Ensure all projects within the team meet objectives and timelines; and Lead the development of Programming standards, applications and processes to maximize efficiencies. Qualifications Bachelor/Master degree in statistics, mathematics, health informatics, computer science, or related field; Proficiency in SAS programming skills; 5 years of clinical programming experience; Strong communication skills and coordination skills; and Good leadership skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Senior SAS Programmers to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Propose and develop specifications for new projects and serve as a project team leader Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Responsible for the setup, validation and maintenance of mapped databases, integration of external data with associated edit checks, writing programs independently with good quality for use in creating analysis datasets, tables, listings, and figures. Responsible for mapped database setup, validation and maintenance, and external data integration & edit checks, validation, and maintenance Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field 5+ years' eperience with SAS Excellent knowledge of CDISC standards SAS Certification Thorough understanding of the pharmaceutical industry and Federal Regulations regarding electronic records Excellent analytical, written and oral communication skills Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

The Data Engineer will work closely with clients and the eCS Biometrics team to optimize the elluminate® platform for end-to-end solutions to aggregate, transform, access and report on clinical data throughout the life cycle of a clinical trial. This includes study design in elluminate®, collaboration on specifications, and configuration of the various modules to including Data Central, Clinical Data Analytics and Trial Operational Analytics, Risk-Based Quality Management (RBQM), Statistical Computing Environment (SCE) and Operational Insights. The Data Engineer will be involved in standard ETL activities as well as programming custom listings, visualizations and analytics tools using Mapper and Qlik. The position involves a high level of quality control as well as adherence to standard operation procedures and work instructions and a constant drive towards automation and process improvement. Key Tasks & Responsibilities Design, develop, test, and deploy highly efficient code for supporting SDTM, Custom reports and Visualizations using tools like MS SQL, elluminate® Mapper and Qlik Configure ETL processes to support of the aggregation and standardization of clinical data from various sources including EDC systems, SAS and central laboratory vendors Work with Analytics developers, other team members and clients to review the business requirements and translate them into database objects and visualizations Manage multiple timelines and deliverables (for single or multiple clients) and managing client communications as assigned Provide diagnostic support and fix defects as needed Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures Other duties as assigned CANDIDATE’S PROFILE Education & Experience 3+ years of professional experience preferred Bachelor's degree or equivalent experience preferred Experience with database/warehouse architecture, design and development preferred Knowledge of various data platforms and warehouses including SQL Server, DB2, Teradata, AWS, Azure, Snowflake, etc. Understanding of Cloud / Hybrid data architecture concepts is a plus Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus Professional Skills Critical thinking, problem solving and strong initiative Communication and task management skills while working with technical and non-technical teams (both internal to eCS and clients) Must be team oriented with strong collaboration, prioritization, and adaptability skills Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions Excited to learn new tools and product modules and adapt to changing technology and requirements Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred Technical Skills Proficient in SQL, T-SQL, PL/SQL programing Experience in Microsoft Office Applications, specifically MS Project and MS Excel Familiarity with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related Show more Show less

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions Provide statistical programming and validation for life sciences-related projects including clinical trial datasets and tables, listings, and figures. Access and convert data to SAS datasets and other file types from database management system and PC file formats (e.g., Microsoft Excel, text files). Work with external vendors to develop and/or monitor the content and structure of SAS datasets and other files. Work closely with statisticians and other statistical programmers to generate and validate outputs to ensure accuracy and ensure the quality and soundness of statistical programming algorithms. Provide input to specifications of tabulation and analysis datasets, validation plans, and other related documents Other duties as assigned. Necessary Skills And Abilities In-depth knowledge of statistical programming. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners. Ability to program in SAS and/or R preferred. Educational Requirements Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with 1+ years of relevant work experience. Experience Requirements Experience with CDISC data structures, such as SDTM and ADaM. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Show more Show less

Let’s build the future of medicine—together. Join Enveda as a Sr. Manager, Clinical SAS Programming in India and help us transform natural compounds into life-changing medicines. We’re a team driven by curiosity and innovation—are you ready to make a difference? Hybrid | India | Full-Time What Makes Us Enveda Life is smart, and we can learn from it. We’re reinventing drug discovery by harnessing nature’s intelligence. Our platform identifies new medicines four times faster than the industry standard—because patients can’t wait. What sets Enveda apart isn’t just what we do—it’s how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe “People Create All Value”, and our success is driven by the extraordinary team turning our mission into reality every day. We’re Proud Of The Momentum We’ve Built Jan 2024: Named a LinkedIn “Top Startup to Watch” Mar 2024: Forbes America’s Best Startup Employers Oct 2024: First drug to Phase 1 Clinical Trials Dec 2024: Raised a $130M Series C These milestones reflect the impact of our team and we’re just getting started, but they’re only possible because of the diverse talent, perspectives, and relentless drive of our team, and people like you. Your Role in Our Mission At Enveda, every role drives impact. As a Sr. Manager,Clinical SAS Programming, you’ll be at the forefront of delivering hope to patients everywhere. Your expertise in clinical programming will be critical in accelerating our mission to deliver submission-ready datasets and regulatory documentation—because every breakthrough starts with bold questions and brave actions. What You’ll Do Lead programming activities across studies and clinical development phases Oversee CRO deliverables for quality, timeliness, and regulatory compliance Provide technical oversight for SDTM, ADaM, Define.xml, DRGs, and TLFs We’re Looking For 8-12 years clinical programming exp. with leadership exposure Expert SAS skills (Base, Macro, SQL); strong SDTM, ADaM, Define.xml, TLF experience Bachelor's/Master's in Statistics, CS, Life Sciences, or related field Proven CRO management experience across selection, oversight, and delivery Strong Hands-on R skills for exploratory analysis and visualization Preferred: Familiarity with Pinnacle 21, CDISC validation, ISS/ISE, and automation tools If you’re passionate about innovation and impact, we encourage you to apply—even if you don’t meet every requirement. Our Values: Curiosity | Agency | Journey | Charity | Unity Benefits: Culture | Medical | Block Leaves | Work-Life Harmony At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. 👉Apply now and join a team committed to shaping the future of drug discovery. Show more Show less

TCS is hiring for Statistical Programmer!!! Job Location Mumbai/Pune/Bengaluru Experience Range 4 to 14 Years Educational Qualification(s) Required Any Life Science Graduate Interested can share their CV on babeeta.shahi@tcs.com Roles & Responsibilities:- Creation and validation of analysis data sets, tables, listings and figures . Creation and validation of ISS and ISE reports. . Development and testing of reusable Standard Programs . Development of SAS macros to work as utilities to automate routine activities . Remapping of old studies into ADaM structure . Build and maintain ADaM compliant Repository . Creation and validation of ADaM specification document . Assistance in creation of regulatory submission documents

Sr. Statistical Programmer - FSP (India) Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members. Key Responsibilities Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project Codes complex SAS programs for applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from the supervisor Create specifications for derived/analysis datasets Program analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS Generate SDTM domains, ADaM datasets Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers Performs review on define.xml and creates reviewers guide for SDTM and ADaM datasets Review, and maintain study documents per the standard process Perform other duties as assigned Technical And Communication Skills Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH Demonstrates intermediate knowledge of electronic submissions and CDlSC Proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately and on schedule Effective communicator (written and verbal), especially within their area(s) of expertise Preferred Education And Experience MS in biostatistics or a related field, with 5-8 years of experience in the pharmaceutical industry, or BS in biostatistics or a related field, with 7-10 years of experience in the pharmaceutical industry Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law. Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies. Show more Show less

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. Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. 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 areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams. Lead knowledge sharing forums and proactively support the development of the wider department. 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. Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity. Represent Statistical Programming on cross-functional technical initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills Excellent analytical skills. Advanced knowledge of SAS programming techniques. Extensive knowledge and understanding of the programming and reporting process. Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated. 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 and mentor a global team. Work effectively in a quality-focused environment. Excellent time management in order to meet daily metrics or team objectives. Show commitment to and perform consistently high quality work. Strong business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Ability to negotiate and influence in order to achieve results. Good business awareness/business development skills (including financial awareness). Client-focused approach to work. Good negotiation skills. Knowledge And Experience Competent in written and oral English. Excellent communication skills. Proven record of successfully leading teams in a statistical programming environment. Education Educated to degree level in a relevant discipline and/or equivalent work experience. Show more Show less

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Create SAS programs to generate derived analysis data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and revi e w Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programmi ng assumptions and requirements ; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required . At least 5 years programming experience in industry recommended . For US positions: US military experience will be considered towards industry experience . Demonstrated proficiency in using SAS , R or other programming languages to produce deriv ed analysis datasets and TFLs. Have in -depth understanding of clinical data structure ( e.g. CD I SC standards) and relational database. Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e.g., multiple d ata forms, workflow, eDC , SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM , Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environm ent with clinical team members. Preferred Requirements : Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings ( e.g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology , statistics and familiarity with global regulatory requirements Experience in other software packages ( e.g. R) Experience with the Linux operating system If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As 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 analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. 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. Build 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. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field 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 Desirable Skills/Experience: 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's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Principal Statistical Programmer Posted date Jun. 06, 2025 Contract type Full time Job ID R-228434 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As 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 analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. 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. Build 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. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field 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 Desirable Skills/Experience: 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's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

India - Hyderabad JOB ID: R-214635 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 05, 2025 CATEGORY: Research Let’s do this. Let’s change the world. In this vital role you will collaborate with teams across multiple time zones to fulfill requests, clarify requirements, escalate issues, and deliver high-quality results. The Sr Associate Biostatistical Programming will report to a locally based Biostatistical Programming Manager. The Sr Associate Biostatistical Programming will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least four years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential. Responsibilities: Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications Provide technical solutions to programming problems within CfOR(Centre for Observational research). Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Manage all programming activities, according to agreed resource and timeline plans Ensure all programming activities on the project adhere to departmental standards Write and/or review and approve all programming plans Write and/or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test, validate and execute department-, product- and protocol-level macros and utilities Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings Participate in the recruitment of programming staff Actively participate in external professional organizations, conferences and/or meetings Provide input to and participate in intra-departmental and CfOR meetings Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) Manage staff performance and oversee staff assignments and utilization What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Bachelor’s degree and 3 to 5 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Diploma and 7 to 9 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience Preferred Qualifications: Experience in SQL, and statistical programming using SAS or R Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans Project fulfillment, statistical programming, issue escalation, results delivery Statistical programming: SQL required; SAS or R required; Python preferred Motivated to learn how to work with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies Hands-on programming role Expert statistical programming knowledge using SAS or R Required: SAS or R Required: SQL Preferred: Python Excellent verbal and written communication skills in English Ability to have efficient exchanges with colleagues across geographical locations Agile project management Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare OMOP common data model Drug development life cycle Statistics and basic epidemiology: Incidence and prevalence [Required for Regulatory RWE role]: CDISC (SDTM, ADaM) Scientific / technical excellence Oral and written communication, documentation skills Leadership Innovation Teamwork Problem solving Attention to detail Learning mindset 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. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

Senior Data Engineer Category: Data & AI Location: Bangalore, Karnataka, IN Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflows? Do you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovation? If so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It includes: Design, implement, and maintain scalable data pipelines and integration solutions aligned with the overall data architecture and strategy. Implement data transformation workflows using modern ETL/ELT approaches while establishing best practices for data engineering, including testing methodologies and documentation. Optimize data workflows by harmonizing and securely transferring data across systems, while collaborating with stakeholders to deliver high-performance solutions for analytics and Artificial Intelligence. Monitoring and maintaining data systems to ensure their reliability. Support data governance by ensuring data quality and consistency, while contributing to architectural decisions shaping the data platform's future. Mentoring junior engineers and fostering a culture of engineering excellence. Qualifications Bachelor’s or master’s degree in computer science, Software Development, Engineering. Possess over 10 years of overall professional experience, including more than 4 years of specialized expertise in data engineering. Experience in developing production-grade data pipelines using Python, Data-bricks and Azure cloud, with a strong foundation in software engineering principles. Experience in the clinical data domain, with knowledge of standards such as CDISC SDTM and ADaM (Good to have). Experience working in a regulated industry (Good to have). About the department You will be part of the Global Data & AI team. Our department is globally distributed and has for mission to harness the power of Data and Artificial Intelligence, integrating it seamlessly into the fabric of Novo Nordisk's operations. We serve as the vital link, weaving together the realms of Data and Artificial Intelligence throughout the whole organi-zation, empowering Novo Nordisk to realize its strategic ambitions through our pivotal initiatives. The atmosphere is fast-paced and dynamic, with a strong focus on collaboration and innovation. We work closely with various business domains to create actionable insights and drive commercial excellence. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). Apply Now! Deadline 20th June 2025. Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Responsibilities Act as an internal Subject Matter Expert and Work independently to support various programming activities related to analysis and reporting of clinical study data. Perform as Statistical Programming Coordinator on projects and interact with Sponsors, Data Operation Lead and other functions as a key contact with regard to statistical programming issue. Use efficient programming techniques to produce and QC of derived datasets and TLF. Create/modify standard macros and applications to improve the efficiency. Develop wider knowledge of SAS and other relevant programming languages and processes. Understanding regulatory requirements concerning industry technical standards, maintain all supporting documentation in accordance with WSOPs/guidelines. Provide relevant training and mentorship to staff and project teams A graduate or Master degree in a relevant educational filed life science, computer, pharmacy, others. Proficiency in SAS and knowledge of programming and reporting process. Excellent experience with TLF, SAS coding, Macros, SQL, PROC reports, SDTM, ADAM(preferred) Requirements Knowledge of WSOPs/ICH-GCP and System Life Cycle methodologies. Excellent communication (written & oral) skills and strong leadership ability. Strong organizational skills, flexible to change and team work. Ability to manage complex projects and business operational skills Study lead experience. For Associate Manager and Manager Role you must have people management (LM)experience. First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent Competent in written English. Good communication skills. Show more Show less

Job Title: Analytics and Reporting (A&R) – Biometrics Dev Ops Lead Career Level: E Introduction to role Are you prepared to apply your expertise in biometrics and DevOps to make a real impact? As an A&R Biometrics DevOps Lead, you will be a key member of the A&R Product IT DevOps team, managing core A&R applications such as Entimice and SAS GRID. Collaborate with Platform Managers, Product Managers/Owners, Senior Platform Engineers, Release Managers, and Solution/Integration Architects to establish standard processes in software development, business analysis, solution design, enterprise software integration, and project management within the BizDevOps IT Platform Delivery Model. Accountabilities Collaborate with vendors and internal collaborators to define requirements and develop implementation plans. Monitor system change requests and ensure alignment to IT standards. Serve as Technical Subject Matter Expert (SME) for SAS-related applications. Provide guidance and assist in the preparation of system-related specifications and documentation. Maintain day-to-day application systems, identifying and solving issues. Ensure all production changes align with life-cycle methodology and risk guidelines. Work on application enhancements and upgrades as vital. Liaise with internal teams/vendors to address application issues. Communicate effectively with users during planned/unplanned outages. Follow good documentation practices by creating and publishing Knowledge Base Articles (KBAs). Create technical backlogs/Story/Epic in JIRA based on product priority. Essential Skills/Experience Biometrics (A&R) Domain/Technology Bachelor or master’s degree in computer science or life science related field with IT/CRO/Pharma experience with a total of 15 years of experience. Industry experience working or implementing solutions based on CDISC Clinical Reporting Standards (SDTM, AdaM, TLF Reporting). Minimum 7-8 years working experience in SAS GRID related administration. Accredited Certifications SAS Administration from Vendor. Good understanding of SAS Programming & shell scripting, reporting tools, infrastructure. Ensure system security and control procedures are implemented and maintained. Maintain configuration specification documentation for functional and integration configuration. Work with software vendors on product requirements and issues related to the platform. Knowledge of client-server networking and database management. Administration background in SAS Viya 3.5/4.0 environments. Experience with SAS Visual Analytics & Power BI highly preferred. Familiarity with shell scripting & groovy scripting. Experience in R and Python is an added advantage. End-to-end knowledge of clinical trial development processes and associated system landscape. Solid grasp of common industry standard business practices related to clinical trials. Strong knowledge of ICH/G guidelines, 21 CFR Part 11, clinical trial methodology, and software development lifecycle activities. Knowledge of support processes like Incident Management, Problem Management, Change Management. Knowledge or experience with JMP Clinical, JReview, StatXact, CR Toolkit, Pinnacle 21. IT Engineering: Expertise and engineering attitude to help design and implement Clinical Data Solutions adhering to Products on Platform Strategy. Demonstrable ability to handle diverse collaborators and ensure high satisfaction delivery. Ability to work independently in a dynamic environment. Good communication and interpersonal skills to lead customers in urgent situations. Experience in Gxp validated systems implementation and maintenance of applications. Knowledge of Identity management solutions based on AZURE, OKTA, Oauth, Ping Federate/AD technologies. Understanding database concepts for optimizing reporting, data mapping, and programming. Experience in developing Interfaces/Integration between on-premises and SaaS Platform enabled Products using API’s, Web Services (MuleSoft), and ETL (SnapLogic) tech enablers. Knowledge of using/creating build tools and CI/CD (maven, ant, gradle, Sonar). Experience with Cloud Platforms such as AWS, AZURE. Experience working with JIRA, Confluence, Bitbucket, Automated Testing tools. Experience working in agile teams using methodologies such as SCRUM and SAFe & leading a team of 5+ & working in an Agile DevOps model. Experience programming in Java or other object-oriented programming languages. Experience delivering or developing workshop material, training, gap analyses, or requirements gathering sessions with business and system collaborators. Certification in IT delivery framework, Scrum Master, DevOps Lead role. Participate in business requirement gathering and design activities with business & IT collaborators as part of scrum team. Perform delivery activities through Design/Build/Test/Deploy phases for regular releases on A&R platform. When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world. At AstraZeneca, we demonstrate technology to impact patients' lives by developing life-changing medicines. We are a purpose-led global organization that pushes the boundaries of science. Our work directly impacts patients by redefining our ability to develop life-changing medicines. We empower our business to perform at its peak by combining ground breaking science with leading digital technology platforms and data. Join us at a crucial stage of our journey to become a digital and data-led enterprise. Here you can innovate, take ownership, experiment with groundbreaking technology, and solve challenges that have never been addressed before. Ready to make a difference? Apply now! Show more Show less

Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As 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 analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. 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. Build 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. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field 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 Desirable Skills/Experience: 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's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Principal Statistical Programmer Posted date Jun. 06, 2025 Contract type Full time Job ID R-228434 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-228434 Date posted 06/06/2025 Job Title: Principal Statistical Programmer Introduction to role: Are you ready to make a significant impact in the world of biopharmaceuticals? As 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 analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. 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. Build 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. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field 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 Desirable Skills/Experience: 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's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful. Ready to make a difference? Join us at AstraZeneca's Alexion division today! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.