277 Sdtm Jobs - Page 9

Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209

Job Title: Statistical Programmer (R) Location: Remote About the Role: We are seeking a talented Statistical Programmer with a strong background in R programming to join our dynamic team. In this role, you will collaborate with statisticians, data managers, and clinical researchers to deliver high-quality statistical programming support for clinical trials and research studies. You will be responsible for data preparation, analysis, and the generation of statistical outputs, ensuring compliance with regulatory standards. Key Responsibilities: Develop and validate statistical programs using R to support clinical trial analysis and data visualization. Create and maintain analysis datasets, summary tables, listings, and graphical presentations. Collaborate closely with statisticians to ensure accurate and efficient data analysis. Contribute to the development of statistical analysis plans (SAP) and programming specifications. Participate in data quality checks and data review processes. Ensure compliance with regulatory guidelines (e.g., CDISC, ICH, FDA) and internal quality standards. Troubleshoot and resolve programming issues related to data processing and analysis. Document programming work for transparency and reproducibility. Qualifications: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. 3+ years of experience in statistical & R programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in R programming, including package development and data manipulation. Strong understanding of clinical trial data and statistical methodologies. Experience with CDISC standards (SDTM, ADaM) is a plus. Show more Show less

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Programming in Clinical Domain To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 291 b) To Apply for above Job Role ( Pune ) Type : Job Code # 292

Statistical Programmer – L2 Job Summary: Statistical Programmer reports to Principal Statistical programmer 3/ Lead, Statistical Programming (L4 (3) or M1) , is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role. Knowledge, Skills & Abilities: Clinical Domain knowledge Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package) SAS Programming (Experience up to 2 years) Python Programming will be an added advantage R Programming will be an added advantage Good Communication skills, learning attitude and good team player Education and Work Experience: Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute. Total experience is between 2 - 4 years Responsibilities: Ability to pick up multiple tools/technologies on the job. Import and Export raw data Contribute to Mapping specifications Utilize SAS/R programming/Python programming skills for clinical trial study submissions Develop programs identifying data issues and reporting them to the appropriate team Utilize appropriate guidelines to build CDISC/regulatory compliant datasets Understand CRF annotations and check for consistency with raw data Ability to debug custom functions/SAS Macros and fix issues Good understanding of clinical data and domain Follow Client Processes and SOPs Assist senior team members in quality control processes Assist senior team members with team metrics Communicate with an internal team to create deliverables for pharmaceutical and CRO clients Work in tandem with Biostatistics and Data Management members on clinical projects Communicate with programming and statistics leads Make sure you are compliant with company policies/SOPs. About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com.

Summary Join our team at data42! The vision of data42 is to inspire collaborative groundbreaking data and AI initiatives, to reimagine drug discovery at Novartis and accelerate time to market, ultimately transforming healthcare and improving lives. We are a small team dedicated to bringing this vision to life by accelerating secondary research and data-driven decisions where we provide scientific support and data ready for analysis in a collaborative environment, leveraging a secure and governed AI-enabled platform. As Data Engineer, you will work alongside data scientists and domain experts to enable teams to answer scientific questions using multi-modal data on the data42 platform. You will be involved in gathering use-case requirements, performing data engineering activities, building ETL processes/data pipelines in quick iterations to deliver data ready for analysis. You will integrate data engineering best practices and data quality checks and seek to continuously optimize efficiency. About The Role Your responsibilities will include, but are not limited to: Collaborates with domain experts, data scientists and other stakeholders to fulfil use-case specific data needs. Designs, develops, tests, and maintains ETL processes/data pipelines to extract, prepare and iterate data for analysis in close alignment with TA / DA scientific leads and data scientists. Implements and maintains data checks to ensure accurate and high quality-data in close collaboration with domain experts. Identifies and rectifies data inconsistencies and irregularities. Promotes culture of transparency and communication regarding data modifications and lineage to all stakeholders. Implements and advocates for data engineering best practices, ensuring ETL processes/data pipelines are efficient, well-documented and well-tested. Plays a role in knowledge sharing across data42 and wider data engineering community at Novartis. Ensures compliance with Security and Governance Principles. Minimum Requirements Bachelor’s degree in computer science or other quantitative field (Mathematics, Statistics, Physics, Engineering, etc.) or equivalent practical experience. Proven experience as a data engineer, data wrangler or a similar role. Exceptional programming skills with expertise in Python, R and Spark. Experience and familiarity with a variety of data types, including but not limited to images, tabular, unstructured, and text. Experience in scalable data processing engines, data ingestion, extraction and modeling. Proficient knowledge in statistics, with an ability to assess data quality, errors, inconsistencies, etc. Good knowledge of data engineering best practices Excellent communication and stakeholder management skills. Demonstrated ability to work independently and as part of global Agile teams. Desirable additional skills in two or more of the following areas: Hands on experience on Palantir Foundry (Code Repository, Code Workbook, Contour, Data Lineage, etc.) Knowledge of CDISC data standards (SDTM, ADaM) Experience using AI (eg: GenAI/LLMs) for data wrangling. Experience with pooling of clinical trial data. High-level understanding of the drug discovery and development process. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Description Statistical Programmer – L2 Job Summary Statistical Programmer reports to Principal Statistical programmer 3/ Lead, Statistical Programming (L4 (3) or M1), is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role. Knowledge, Skills & Abilities Clinical Domain knowledge Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package) SAS Programming (Experience up to 2 years) Python Programming will be an added advantage R Programming will be an added advantage Good Communication skills, learning attitude and good team player Education And Work Experience Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute. Total experience is between 2 - 4 years Responsibilities Ability to pick up multiple tools/technologies on the job. Import and Export raw data Contribute to Mapping specifications Utilize SAS/R programming/Python programming skills for clinical trial study submissions Develop programs identifying data issues and reporting them to the appropriate team Utilize appropriate guidelines to build CDISC/regulatory compliant datasets Understand CRF annotations and check for consistency with raw data Ability to debug custom functions/SAS Macros and fix issues Good understanding of clinical data and domain Follow Client Processes and SOPs Assist senior team members in quality control processes Assist senior team members with team metrics Communicate with an internal team to create deliverables for pharmaceutical and CRO clients Work in tandem with Biostatistics and Data Management members on clinical projects Communicate with programming and statistics leads Make sure you are compliant with company policies/SOPs. About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com. Show more Show less

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Statistical Programmer II (“Programmer”) will have experience in all required areas of a Statistical Programmer I. The Statistical Programmer II is responsible for providing programming support for clinical trials. Responsibilities: Exceed expectations and responsibilities of a Statistical Programmer I Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions May serve as programming lead with responsibility for coordination of activities and timelines May prepare programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: SDTM, ADaM or other derived datasets Tables, listings and figures Review and provide input on case report form design Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures Additional Responsibilities Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 2 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. Equal Employment Opportunity It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available. Show more Show less

Job Purpose: We are seeking a Team lead for our Biometrics function in India, who can manage a team of Biostatistics, Statistical Programming & Clinical Data Management. This role serves as the single point of contact for the Biometrics team in India, coordinating activities across functions and supporting alignment with global development goals. Proven expertise in Biometrics and expected, a solid understanding of all three functional areas is essential for cross-functional coordination and communication with U.S. leadership. Duties and responsibilities: Oversee the day-to-day activities of the Biostatistics, Statistical Programming & Clinical Data Management teams in India. Coordinate with U.S.-based Biometrics leadership to align deliverables and timelines across global development programs. Support biostatistical leadership by overseeing the development and validation of Statistical Analysis Plans (SAPs), as well as generation of tables, listings, and figures (TLFs) for clinical study reports (CSRs). Supervise the creation and validation of SDTM and ADaM datasets in compliance with CDISC standards. Collaborate with Clinical Data Management leads (where applicable) to ensure effective Clinical Data Management practices and data quality. Ensure alignment of Biometrics activities with overall project goals, timelines, and regulatory requirements. Monitor workload, resourcing, and productivity across the India Biometrics team. Facilitate communication and integration across functional teams (Biostatistics, Statistical Programming & Clinical Data Management). Mentor and support the development of team members across both disciplines. Stay current with industry standards and regulatory expectations in Biostatistics, Statistical Programming , CDISC, and Clinical Data Management practices. Qualifications: Masters degree in Biostatistics, Statistics, Clinical Data Science, Life Sciences, or a related field. 15+ years of experience in the pharmaceutical, biotechnology, or CRO industry within biostatistics, statistical programming, and/or Clinical Data Management. Strong working knowledge of clinical trial processes and relevant regulatory requirements (e.g., GCP, CDISC, BLA/NDA submissions). Hands-on expertise Biometrics with all three functions (Biostatistics, Statistical Programming & Clinical Data Management). Ability to lead and manage cross-functional technical teams. Strong project management, problem-solving, and interpersonal communication skills. Proficiency in relevant tools and platforms (e.g., SAS, R, EDC systems, CDMS, Veeva eTMF, Quality Docs, and eQMS platforms). Experience working in a global team structure and across time zones. Proven track record of leading and managing cross-functional biometrics teams, with experience in overseeing the development and validation of statistical analysis plans and clinical study reports. Experience with CDISC standards (SDTM and ADaM) and proficiency in statistical programming languages (e.g., SAS, R). Familiarity with electronic data capture (EDC) systems and Clinical Data Management systems, with a strong understanding of data integrity and quality practices. Demonstrated ability to manage multiple projects simultaneously in a fast-paced environment, with excellent organizational and problem-solving skills. Strong interpersonal and communication skills, with the ability to collaborate effectively with global teams and senior leadership. Commitment to continuous professional development and staying current with industry trends and best practices. Experience with Microsoft-based applications and ability to learn internal applications/systems, including Veeva platforms such as Quality Docs, eTMF, and CDMS. Experience with eQMS systems is a plus. Working conditions: This position operates in an office setting. The job may require an incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Senior Statistical Programmer (“Programmer”) will have experience in all required areas of a Statistical Programmer II. The Senior Statistical Programmer is responsible for providing programming support for clinical trials. Responsibilities: Exceed expectations and responsibilities of a Statistical Programmer II Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on assigned studies Coordinate and ensure the accuracy and completeness of activities for assigned support programmers Create and maintain project timelines Support the development of tools and macros to improve quality and efficiency of processes Prepare programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: Analysis datasets (SDTM, ADaM, other derived datasets) Tables, listings and figures xml/Reviewer’s Guide Integrated summaries Perform ad hoc analyses of current and legacy databases Review and provide input on case report form design Serve as a mentor to other programmers Maintain awareness of scope of work to actual work, alerting management of potential change orders or resourcing needs Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures May participate in the development and revision of department SOPs Business Development May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc. Additional Responsibilities May assist in the preparation and review of monthly financial reporting May promote visibility outside of the functional area and effectively interact cross-functionally and in industry May participate in candidate interviews Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 4 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. Equal Employment Opportunity It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available. Show more Show less

Senior Biostatistician Location: Chennai, India (Hybrid/Remote options available) Department: Biostatistics About the Company A well-established, full-service CRO with over three decades of experience supporting statistical analyses and programming across all phases of drug development. The Biostatistics Division is recognized for its scientific integrity, quality deliverables, and timely execution. Role Overview The organization is seeking an experienced Senior Biostatistician to lead statistical activities in clinical trials. This individual will uphold high standards of scientific rigor and ensure regulatory compliance while working closely with teams across clinical data management, programming, and medical writing. Key Responsibilities Contribute to study design and draft statistical sections of clinical trial protocols Perform sample size and power calculations; generate randomization schedules Develop and review Statistical Analysis Plans (SAPs) and table shells Conduct statistical programming to generate efficacy-related tables, listings, and figures Review statistical output for accuracy and completeness Conduct literature reviews to support statistical methods Ensure adherence to internal guidelines and external regulatory standards Participate in client and regulatory audits Contribute to interpreting clinical trial results and assess clinical relevance Collaborate with cross-functional teams throughout the project lifecycle Qualifications Master’s or Ph.D. in Biostatistics, Statistics, or related field At least 5 years of experience in clinical trial biostatistics within a CRO or pharma environment Proficient in SAS and/or R Strong understanding of statistical methodologies including linear regression, survival analysis, and Bayesian approaches Experience analyzing and interpreting clinical data Familiarity with statistical analysis plans and research study design Excellent analytical and problem-solving abilities High attention to detail and accuracy Strong communication skills, with the ability to explain complex statistical concepts to varied audiences Capable of working independently and in a team setting Preferred Skills Experience with CDISC standards (SDTM, ADaM) Knowledge of regulatory guidelines (FDA, EMA, ICH) Strong interpersonal and project management skills Experience mentoring junior statisticians and contributing to SOPs, templates, or standards Show more Show less

Job Description SDTM Mapping with SAS,SQL End to End SDTM Mapping activities Spec creation Validation and CRF Experience and Skills Required Minimum 3+ years in End to End SDTM Mapping activities Location- Mumbai/ Pune/ Bangalore SDTM Mapping activities Skills Required RoleSDM Industry TypeITES/BPO/KPO Functional AreaPharmaceutical Required EducationAny Graduates Employment TypeFull Time, Permanent Key Skills SDTM MAPPING ACTIVITIES Other Information Job CodeGO/JC/21472/2025 Recruiter NameSangeetha Show more Show less

Strong experience in Statistical Programming(SDTM, ADAM, TLF )in clinical domain using R (must required) and SAS. Data analysis, visualization and advanced statistical modeling using R and SAS will be an added advantage. Should have experience in programming SDTM, ADAM, TLF in the clinical domain. Develop, validate, and implement statistical models using SAS and R. Analyze large datasets to identify trends, patterns, and insights. Design and generate reports and dashboards for various stakeholders. Automate data processing tasks using SAS macros and R scripts. Collaborate with cross-functional teams to understand data needs and deliver actionable insights. Ensure data quality and integrity through rigorous testing and validation. Provide recommendations based on data analysis to support strategic decisions Excellent analytical, problem-solving, and communication skills. Ability to manage multiple tasks and projects with a high attention to detail.

Location Bengaluru, Karnataka, India Job ID R-226586 Date posted 28/05/2025 Job Title: Senior Statistical Programmer II – Early Phase Career level: D Introduction to role: Are you ready to make a difference in the world of medicine? As a Senior Statistical Programmer II - Early Phase, you'll be at the forefront of statistical programming activities for early phase studies across various therapeutic areas. You'll ensure compliance with SOPs, maintain programming infrastructure, and produce quality deliverables. Whether leading projects or collaborating with biostatisticians and programming teams, your expertise will be crucial in developing oversight plans and ensuring adherence to regulatory requirements. You'll mentor others, integrate statistical concepts with SAS programming, and work independently to drive success. Accountabilities: Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM, and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Minimum of 6 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 High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge and implementation of: SDTM and ADaM principals Relational Databases. Good Clinical Practice principals. Good Programming Practice principals. 21CFR Part 11 Standards principals. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. When we put unexpected teams in the same room, we unleash 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 ambitious world. At AstraZeneca, you'll find an environment where your expertise is valued and visible. We thrive on innovation, constantly seeking new ways to improve and make a tangible difference in patients' lives. Our collaborative approach allows us to harness diverse perspectives, pushing boundaries to achieve groundbreaking solutions. With countless learning opportunities across global therapy areas, you'll have the chance to grow both personally and professionally while contributing to research that impacts society worldwide. Ready to take on this exciting challenge? Apply now to join our dynamic team! Date Posted 29-May-2025 Closing Date 25-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

Hi, Wishes. Pleasure connecting with you. Job Summary: We are hiring mid-level Statistical Programmers (4 - 8 years of experience) with strong hands-on expertise in SAS programming for clinical trials. The role requires experience in SDTM and ADaM dataset creation, TLF programming, and knowledge of CDISC standards. You will be working on end-to-end programming activities for Phase IIV clinical studies. Mode of Work : WFO Exp Range : 4 to 8 yrs Work Location : CHENNAI CTC Range : Best in the industry ***** Looking for SHORT JOINERs ***** Key Responsibilities: SDTM Programming: Create and validate SDTM datasets as per CDISC guidelines. Perform CRF annotation and author/review specifications . Generate Define.xml and ensure compliance using Pinnacle 21 . Work on Study Data Reviewers Guide (SDRG) and submission packages. ADaM Programming: Develop ADaM datasets for Safety and Efficacy analysis. Write and validate ADaM specifications and ensure alignment with SAP. Prepare ADaM Define.xml and reviewer documentation. TLF Programming: Generate and QC Tables, Listings, and Figures (TLFs) as per SAP. Use SAS Graph and macros to build clinical outputs. General Programming & Project Work: Independently write or modify SAS programs from scratch or using templates. Develop or enhance custom macros to streamline programming tasks. Work in both production and validation programming roles. Handle multiple studies simultaneously , ensuring high-quality deliverables. Participate in integration and pooling (ISS/ISE) of datasets. Work on CRT packages and electronic submission readiness. Required Skills: Strong knowledge of SAS Base, SAS/STAT, SAS/GRAPH in a clinical trial setting. Solid understanding of CDISC SDTM and ADaM standards . Experience with Define.xml creation and validation tools like Pinnacle 21 . Hands-on exposure to multiple therapeutic areas and clinical phases . Experience in ISS/ISE and integrated datasets is a strong plus. Nice to Have: Familiarity with tools such as Define.xml Generator, SAS Clinical Standards Toolkit . Knowledge or EXP in R Programming is OPTIONAL Exposure to MACRO programming and reusable code frameworks . Understanding of regulatory requirements for FDA/EMA submissions . What We Offer: Projects with top global pharma clients. Work with a high-performing and collaborative clinical data team. Competitive compensation, learning, and growth opportunities. If Interested, click APPLY ONLINE for IMMEDIATE response. Best, ANANTH | GSN HR | 9840035825 | Google review : https://g.co/kgs/UAsF9W

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. Quality Control Specialists will maintain project level perspective, focus, and communicate effectively as the quality control subject matter expert. Key Tasks & Responsibilities Perform quality control activities (i.e. documentation review, testing) of Biometrics client’s Rave EDC and Data management deliverables including eCRFs, Data Validation Specification checks, Custom functions, Data Extracts, Data Integrations, Data Mapping, Custom Data Management Reports and listings Participate in the design and development of quality control procedures Manage documentation created during the QC process Liaise with study teams and other staff to fulfill job responsibilities and activities Develop and lead execution of training and knowledge transfer opportunities for quality control team Inform the Manager of training issues, project activities, quality issues and timelines as directed Collaborate with the project team to ensure the deliverables are completed on time with high quality Other duties as assigned CANDIDATE’S PROFILE Education/Language Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field) Excellent knowledge of English Professional Skills & Experience Minimum 3-5 years in Pharmaceutical/Biotechnology industry or equivalent Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and industry standards (CDASH, SDTM) preferred Experience performing quality control activities of clinical trial deliverables preferred Excellent verbal and written communication skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Excellent team player Technical Skills & Experience Extensive knowledge of Medidata Rave EDC platform and other modules of Rave preferred Familiarity with Databases: SQL Server, Oracle highly preferred Extensive validation experience of eCRFs, Edit Checks, Custom Functions, Data Management reports and good understanding of Database structures and Programming languages Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint Show more Show less

Manager, CSAR - Global Library Manager What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Position Summary The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May perform data entry for paper-CRF studies, as needed May perform quality control of data entry Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications Minimum Required: Bachelors and/or a combination of related experience Other Required 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients Experience in utilizing a clinical database management system Broad knowledge of drug, device and/or biologic development and effective data management practices Ability to undertake occasional travel Preferred Understanding of dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Roles and responsibilities: 1) Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Familiarity with multiple statistical procedures and functions to create TFLs Show more Show less

Description JD: Data Manager, Clinical Data Management 10-15 years industry experience Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of the clinical data management and clinical operations process? If yes, Saama is looking out to hire you as we believe it should not take this long to get Drugs out to Market, we believe data and analytics powered by Machine Learning and Artificial Intelligence if put to proper use within Clinical Operations and Data Management organizations can bring significant time and outcome savings. We have re-imagined data-management processes and helped organizations significantly bring down the time it takes to lock a database by up to 95% for Vaccine studies, we don’t want to stop here, we want to recognize process inefficiencies in clinical operations and data management and disrupt them. We are firm believers in re-imagining data management and analytics, what we have done so far is just scratching the surface, a lot more has to be done with you on our team leading some of these transformational initiatives. Product Owner acts as Data Management SME and serves as the main point of contact for customers to implement clinical solutions. You will work closely with Clinical trial sponsors, CROs at the executive and study team level to deliver Saama solutions to our customers. Responsibilities Drive customer implementations to successful launch by providing data management inputs wherever necessary. Work with implementation resources, product, and engineering teams onshore and offshore to deliver innovative solutions to customers. Consult with business leaders to develop and understand the complex and diverse data management needs required for the project. Understand the role of the project in the clinical landscape and determine how changing business needs will affect the project. Collaborate with the customer and internal resources to understand usage and adoption trends and impact increased application use. Partner with Business development and customer success managers to implement solutions, estimate effort and help set customer expectations. Partner with Product Management to help align real-world customer feedback with the product roadmap. Perform the industry research to identify clinical development needs. Requirements Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience. Experience working with EDC, IRT systems and integrations, third party data handling and other clinical systems implementation. Experience in Clean patient tracker, data review, missing pages, data quality checks, 3rd party data reconciliation and use of business intelligence tools like Cognos, Oracle, BI, Tableau, Spotfire, QlikView, Informatica. Familiar with clinical trial data and related workflows. Good understanding of CDISC standards (CDASH, SDTM) and data mappings/transformations. Programming knowledge in SQL or SAS desired. Excellent understanding of common industry standard business practices related to clinical trials (study set up, study conduct, clinical operations process, data management review and reporting). Excellent at translating customer business requirements into enterprise solutions. Proven track record of driving customer success and operating at the executive and department levels within complex customer environments. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment, including but not limited to, computers, phones, and photocopiers. Physical Demands This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. EEO Saama Technologies, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training. Show more Show less

Position Summary: The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May perform data entry for paper-CRF studies, as needed May perform quality control of data entry Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients Experience in utilizing a clinical database management system Broad knowledge of drug, device and/or biologic development and effective data management practices Ability to undertake occasional travel Preferred: Understanding of dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Pharmaceutical & Life Sciences Full-Time Job ID: DGC00485 Chennai, Tamil Nadu 0-3 Yrs ₹4.5 - ₹7.5 Yearly Job description Role & responsibilities: Overseeing the collection, validation and processing of clinical trial data. Developing and implementing data management procedures for clinical trials. Supporting and facilitating the review of medical coding for validity and completeness. Ensuring compliance with applicable regulations, protocols and standard operating procedures in India. Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock. Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management. Preferred candidate profile Certification in clinical data management (like CCDM). Knowledge of CRF design, MS Project and analytical capabilities. Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM). Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). Understanding of data privacy and protection regulations (e.g., GDPR). Effective communication and interpersonal skills to collaborate with other teams.

Summary The purpose of the role is to inventory all of the various data flowing into, across, and out of Novartis Statistical Compute Environments (SCE) and document data modalities, flows, storage, mappings and transformations, as a member of the SCAPE project team. The SCE is under development and will ultimately be used by the Development Advanced Quantitative Sciences (AQS) business domain. This role will collaborate with other SCAPE project workstreams and team members to ensure reliable and efficient data flows are established, documented and maintained according to project timelines and budget. Sound knowledge and experience in working with statistical compute and data science platforms Solid understanding of clinical trial processes and leveraging quantitative sciences and toolsets in regulatory and exploratory pathways Understanding of different data modalities (ex. Biomarkers, Omics, Imaging) Strong knowledge of Clinical data standards (CDISC – SDTM, ADAM, USDM) About The Role Key Responsibilities: Work across Business and IT to identify and document all data types, modalities, forms, etc. across current and future SCEs, including data from upstream and downstream systems relative to the SCEs. Assist SCAPE Project workstreams and team members to understand detailed data types, flows, and transformations relevant to the SCE so that SCE requirements are thoroughly understood and the SCAPE SCE solution delivery is of high quality and complete. Identify opportunities to optimize data flows and data transformations, increasing value to the Business. Take accountability for delivery of specific components / use cases for the SCE Ensure documented data flows and transformations support the development, execution and operations of the SCE Ensure peer review and sign off documentation. Coordinate with all other workstreams on the SCAPE project to deliver a quality SCE on time and within budget Education Essential Requirements Bachelor’s degree in computer science, Computer Engineering or related technical discipline or equivalent experience demonstrated Experience 7 years’ experience working in an IT environment with experience working in Biostats and quantitative science data platforms in Pharma Experience collaborating across geographical and organizational boundaries Advanced knowledge of Lean/ 6 Sigma, Design Thinking, Agile methodology Experience leading indirect reports in a matrix environment Advanced knowledge of Design Thinking and Agile methodology Demonstrated aptitude for learning Hands-on experience identifying and documenting data types, data modalities, and data flows across complex systems and system landscapes. Identifying opportunities for optimizations where possible. Leveraging digital technology and effective change management to deliver value. Track record delivering global solutions at scale, and interactions with senior management. Delivery of validated IT solutions and collaborating across boundaries. Experience in IT Enterprise & Business Architecture, IT Systems Design, IT Systems Integration, User Experience Design, Design Thinking, Analyzing stakeholder requirements, and Knowledge of IT Applications & tools. Experience with AI/ML and Experience with Domino is a plus Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary Assist in the timely & professional ongoing Mgmt of data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team. Ensure high quality data available for secondary analysis use. Support content development and upgrade to training modules into engaging and interactive applications. Follows data regulations and laws, data-handling procedures and data mapping guidelines. Supports quality deliverables within Clinical Data Operations (DO). Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical Data Warehouse. Supports the delivery of quality data, processes and documentation contributor role in ensuring that use case/demands are executed efficiently with timely and high quality deliverables. About The Role Major accountabilities: Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought. Under supervision provides input into writing specifications for use cases/demand and necessary reports to ensure high quality and consistent data -Involved in User acceptance testing (UAT) and managing data mapping activities to maintain Clinical Data Warehouse -Under supervision, participates in ongoing review of all data generated from different sources -Supports the development of communications for initiatives. Perform hands on activities to conduct data quality assessments. Creates under supervision and learns relevant data dictionaries, ontologies and vocabularies -Reporting of technical complaints / special case scenarios related to Novartis data Collaborate with other data engineering teams to ensure consistent CDISC based data standards applied Be familiar with all clinical study documents from protocol to CSR including Data Management and Biostatistic documents. Key Performance Indicators Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Clinical Data Operations activities & deliverables. No critical data findings due to Data Operations-Adherence to Novartis policy, data standards and guidelines -Customer / partner/ project feedback and satisfaction Minimum Requirements Work Experience: 3-5 years of experience in working in clinical trials data reporting Collaborating across boundaries. Knowledge of clinical data Availability of sufficient information to find and understand data Availability of data quality assessments Experience in Agile way of working would be a plus Skills CDISC SDTM/ADaM Mapping Clinical Data Management. Experience in being able to work with different legacy, historical, local data standards SQL basic knowledges Python skills would be a plus Able to work in a worldwide team Data Privacy Data Operations. Data Science. Databases. Detail Oriented. Languages English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

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

Job Title: Associate Director, Statistical Programming Introduction to role The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables. Accountabilities Serve as the Lead Programmer and Manager of the statistical programming efforts. Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. Act as the primary department contact to ensure that department standards are implemented in all studies. Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. 4+ years project management experience in the CRO or Pharmaceutical Industry. Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. Strong verbal and written communication skills - ability to clearly and effectively present information. An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. Advanced experience with: Constructing technical programming specifications. Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. Competencies: Accountability Collaboration Decision Quality Drive for Results Perseverance Problem Solving Informing Peer Relationships Time Management Building Effective Teams Managing Through Systems At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care. Ready to make an impact? Apply now! Show more Show less