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4.0 - 9.0 years

3 - 8 Lacs

Hyderabad

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Role & responsibilities Designing and implementing clinical data collection systems and tools Coordinating with investigators and other healthcare professionals to gather and interpret clinical data Overseeing the data management process, including data collection, entry, verification, and cleaning Ensuring the integrity, accuracy, and security of all clinical data Preparing and maintaining documentation related to data management activities, such as data management plans and standard operating procedures Ensuring compliance with regulatory standards and guidelines, including Good Clinical Practice (GCP) Working closely with biostatisticians and other data scientists to analyze clinical data and generate statistical reports Participating in the preparation of clinical study reports and other regulatory documents Training and supervising data management staff Responsible for coding and categorizing data appropriately Address data queries and discrepancies, and make necessary corrections Develop and maintain data management plans and documentation Participate in the preparation of reports and manuscripts Preferred candidate profile Clinical Database Design Edit check identification and programming SAS programming (optional) Qualifications Proven work experience as a Clinical Data Manager or similar role Experience in a clinical or pharmaceutical environment Strong understanding of data management principles and practices Excellent knowledge of data analysis and reporting tools Experience with Electronic Data Capture (EDC) systems Strong attention to detail and problem-solving abilities Ability to handle multiple tasks and meet deadlines Interested Candidates kindly send me updated resumes to pitchireddy.t@hetero.com

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4.0 - 9.0 years

20 - 35 Lacs

Bengaluru

Remote

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What you'll be doing Create, test and maintain SAS codes used to create and/or validate statistical outputs for the cardiac safety statistical analysis; create and maintain procedures for creation of TFLs/ statistical outputs; provide statistical support under the supervision of senior team resources and/or department management; may supervise staff in a line management or matrix capacity. Develop, test, execute and maintain SAS and R programs for statistical analysis including central tendency analysis, categorical analysis, and concentration-QTc analysis Validate results of statistical analysis by double programming Prepare tables, figures, and listings for statistical analysis as outlined in the statistical analysis plan Perform review of final outputs and reports as it relates to the planned statistical analysis Perform quality checks on CDISC formatted analysis datasets (ADaM) Support research programs and provide research results to the senior team resources and/or department management Provide interpretation of results/reports of statistical analysis including descriptions of methodologies and conclusions to the Principal/Sr. Principal Biostatistician, Medical Writing, and/or Scientific Team Train team members on standard operating procedures and standard methodology Develop process improvements to increase overall operational efficiency Drive ideas for future analyses and data quality efforts What we're looking for A PhD in Statistics, Mathematics or equivalent A Masters degree in Statistics, Mathematics or equivalent and 4+ years of relevant industry experience Bachelor’s degree in Statistics, mathematics or equivalent with 10+ years of relevant industry experience. Familiarity and experience with ANOVA, t-test, regression, and linear mixed-effects modeling. Strong SAS or R programming skills. Experience in clinical trials within a CRO or pharmaceutical research organization Familiarity with Clinical protocols and Statistical Analysis Plans, understanding of the pharmaceutical drug development process Excellent verbal and written communication skills. Awareness of CDISC SDTM and ADaM standards. Strong organization, analytical and communication skills.

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7.0 - 12.0 years

14 - 19 Lacs

Bengaluru

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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: bachelors Degree (Minimum) or masters 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.

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2.0 - 4.0 years

9 - 14 Lacs

Pune

Hybrid

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About the job The role is based in the Pune R&D Center, at SAS R&D Pune facility, SAS9 team. We are looking for an SDET to validate SAS9 ARD software, install/migration process on Windows and Unix platforms along with automating the functional test sets for the SAS 9 platform based (ARD) solutions. You will be joining a friendly team with a broad range of experience, to develop and maintain SAS 9 Solutions. Required Qualifications A minimum of 2-4 years of experience in all facets of software testing in a product-based software development environment SAS Technologies: Base and Advance SAS and SAS Macro Programming Knowledge of performance tuning techniques on SAS Understanding of testing concepts for Base SAS and RDBMS database would be an added advantage Knowledge of programming/Scripting language such as Java/Shell Script, Python etc. for automating deployment process as applicable. Install and administer any of Postgres, Hadoop, Oracle, MySQL, SAS or related DBMS. Independently support / install / configure test environments for multiple projects. The position requires strong ability to think and act like an end-user administrator who would deploy SAS software. Basic understanding of Cloud computing concepts and hypervisors. Must be familiar with all the phases of the Software Development Life Cycle (SDLC) Ability to make recommendations based on solid understanding of the problem resolution, troubleshooting development and environment and functional interaction. Primary Responsibilities Validation and Testing of Deployment/Install process of SAS Software on windows and Unix platforms. Installation/configuration of testing environment and support SAS9 infrastructure and continuous deployment infrastructure. Demonstrate aptitude for problem solving and debugging of complex software systems. Automate the deployment process as applicable using internal tools, Jenkins, Python, Java/Shell scripts etc. Install and administer Postgres, Oracle, MySQL, SAS or related DBMS. Administration of system, third party, and SAS software Design, implement, and maintain automated test frameworks, tools, and scripts that address specific needs. Design and implement test plans (cases, scenarios, usage). Create test strategies, test scenarios, and test ideas with clear intent. Understand complex usage concepts and assess applications ability to fulfill them. Identify risks, issues, potential defects, or defects in any phase of the project life cycle, managing them through closure. Diverse and Inclusive At SAS, it’s not about fitting into our culture – it’s about adding to it. We believe our people make the difference. Our diverse workforce brings together unique talents and inspires teams to create amazing software that reflects the diversity of our users and customers. Our commitment to diversity is a priority to our leadership, all the way up to the top; and it’s essential to who we are. To put it plainly: You are welcome here.

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4.0 - 9.0 years

10 - 14 Lacs

Hyderabad

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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. 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. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

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6.0 - 11.0 years

8 - 13 Lacs

Bengaluru

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Job Title: Senior Statistical Programmer II Career Level: D Introduction to role: Are you ready to make a significant impact in the world of rare disease biopharma? As a Senior Statistical Programmer II, youll be at the forefront of developing and validating programs that create datasets conforming to Alexion and CDISC standards. You will play a pivotal role in generating Tables, Listings, and Figures for analysis purposes. Depending on the complexity of the study, you may lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Your expertise will guide and mentor junior programmers, while your ability to integrate statistical concepts with SAS Programming will drive efficiency and effectiveness. Are you prepared to take on this challenge? 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 principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, youll find yourself immersed in a culture that thrives on innovation and collaboration. Our commitment to transforming complex biology into transformative medicines is unwavering. With a rapidly expanding portfolio in rare disease biopharma, youll have the chance to grow and innovate alongside exceptional leaders and peers. Our entrepreneurial spirit fosters autonomy and connection, empowering you to explore new ideas while meeting the needs of under-served patients worldwide. Here, your career is not just a path but a journey to making a difference where it truly counts. Ready to embark on this exciting journey with us? Apply now to join our team! 04-Jun-2025 04-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.

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5.0 - 10.0 years

25 - 30 Lacs

Pune

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: Job TitleTest Analyst Corporate TitleAVP LocationPune, India Role Description EngineerTechnical specialist What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Liaising with technical architects to develop strong understanding of the architecture and technology stack. Developing test plans and potentially even detailed test scenarios and test cases; ensuring maximum test coverage. Ensuring that testing standards, process, procedure, and methodology are adhered to. Planning and execution of test cycles in an efficient and organized way. Thoroughly review and document quality before handover to SIT/UAT. Test Execution according to plan and thorough analysis of potential defects to help with triaging. Accurately reporting test preparation and execution progress identifying and escalating risks to delivery. Promoting the principles and ideals of automation testing and transferring skills to other QA staff as appropriate. Maintain a current working knowledge of the key business systems and future developments. Work with Test Managers, change team to identify the quality implications of known bugs and the impact of proposed changes to product definition on the testing process. Review requirements, specifications, user documentation, help files, and other project documentation to assure quality of the products and tests to be developed. Ensure proper version control and configuration management of all test objects developed and test environments used. Apply risk-based techniques to develop, maintain, and execute test suites. Work with the Development team/Automation Team to capture and reuse automated Unit Test Cases, Test Stubs and Drivers, and other Development test objects. Supporting the build master implement/improve build test processes, environments, and scripts. Experience and working knowledge of tools such as ALM, creating test plans and test cases. Tools Knowledge such as :- SAS on Mainframe , Bit Bukcet, Jira, Servcie Now etc. Your skills and experience Bachelor's degree in B.Tech/B.A ,Computer Science, Information Systems, Statistics, or related field.Proven experience as a SAS Business Analyst or similar role, with a minimum of 7 years of experience in data analysis and SAS programming.. Excellent communication and interpersonal skills, with the ability to effectively communicate technical concepts to non-technical stakeholders. Ability to work independently and collaboratively in a fast-paced environment with multiple stakeholders and competing priorities. Certification in SAS programming or SAS analytics (e.g., SAS Certified Base Programmer, SAS Certified Predictive Modeler) is a plus. Should have 9-11 years total test experience with 5-7 years of relevant SAS/Mainframe. Experience in leading environments set-up / preparation for Integration/Acceptance testing. Technical skill required:- SAS/Mainframe ( Mandatory) Liaising with business analyst to develop strong understanding of the business process and system requirements. How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs.

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2.0 - 6.0 years

4 - 8 Lacs

Chennai, Delhi / NCR, Bengaluru

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Job Summary: Were looking for a SAS Data Integration (DI) Developer to join our team. In this role, you'll be responsible for designing and optimizing ETL processes using SAS DI Studio, as well as automating job schedules. Youll work with large datasets, ensure data integrity, and collaborate with cross-functional teams to meet business requirements. Additionally, you'll troubleshoot and monitor jobs while ensuring adherence to data governance standards. If you're excited to work in a dynamic and growing environment, this is a great opportunity to apply your skills to cutting-edge technologies. Key Responsibilities: Develop and maintain ETL processes using SAS DI Studio. Design and optimize data workflows, including transformations and macros for high-performance data integration. Schedule and automate jobs using SAS Management Console or other scheduling tools (e.g., Control-M, cron). Monitor, troubleshoot, and resolve issues related to scheduled jobs and ETL processes. Work with large datasets, ensuring data integrity and optimizing performance. Collaborate with teams to meet business requirements and improve data workflows. Create documentation for data integration processes and job schedules. Ensure compliance with data governance and security best practices. Qualifications: Experience with SAS DI Studio, SAS programming, and ETL processes. Expertise in job scheduling and automation using SAS Management Console, Control-M, or cron. Proficient in SQL, data transformation, and data quality assurance. Strong problem-solving and troubleshooting skills. Location: Delhi NCR,Bangalore,Chennai,Pune,Kolkata,Ahmedabad,Mumbai,Hyderabad

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4.0 - 8.0 years

6 - 10 Lacs

Hyderabad

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Job Description: Role Title: AVP, Analytics - H&W Platform (L10) Company Overview: Synchrony (NYSE: SYF) is a premier consumer financial services company delivering one of the industry s most complete digitally enabled product suites. Our experience, expertise and scale encompass a broad spectrum of industries including digital, health and wellness, retail, telecommunications, home, auto, outdoors, pet and more. We have recently been ranked #2 among India s Best Companies to Work for by Great Place to Work. We were among the Top 50 India s Best Workplaces in Building a Culture of Innovation by All by GPTW and Top 25 among Best Workplaces in BFSI by GPTW. We have also been recognized by AmbitionBox Employee Choice Awards among the Top 20 Mid-Sized Companies, ranked #3 among Top Rated Companies for Women, and Top-Rated Financial Services Companies. Synchrony celebrates ~52% women diversity, 105+ people with disabilities, and ~50 veterans and veteran family members. We offer Flexibility and Choice for all employees and provide best-in-class employee benefits and programs that cater to work-life integration and overall well-being. We provide career advancement and upskilling opportunities, focusing on Advancing Diverse Talent to take up leadership roles. Organizational Overview : Our Analytics organization comprises of data analysts who focus on enabling strategies to enhance customer and partner experience and optimize business performance through data management and development of full stack descriptive to prescriptive analytics solutions using cutting edge technologies thereby enabling business growth. Role Summary/Purpose : AVP, Analytics - H&W Platform (Individual Contributor) role is a part of India Analytics Hub (IAH). The primary purpose of this role is to support and grow Health & Wellness platform business by providing strategic and scalable solutions, collaborating with functional teams on key business priorities, deliver high visibility & high-impact projects and working in close collaboration with IAH and US Analytics teams. The candidate must be a thought leader, hands on problem solver and deliver actionable insights for the business. Key Responsibilities : Support Health & Wellness platform business and analytics stakeholders in making informed decisions through data, analytics and insights Proactively discover, lead, and solve open-ended/ambiguous business problems through basic to advanced analytics/data science tools and techniques, as applicable Work hands-on to derive insights from data and/or automate critical processes using analytical techniques, tools, software and provide actionable recommendations to enable effective decision making and reduce execution time, as appropriate Lead the projects by ensuring adherence to timely delivery, accuracy, and documentation in line with audit procedures Contribute to internal initiatives, perform other duties and/or special projects, as assigned Demonstrate project management skills and ability to handle multiple initiatives Required Skills/Knowledge: Degree in Statistics, Mathematics, Economics, Engineering, or any other quantitative streams with 4+ years of hands-on relevant analytics/data science experience, or in lieu of a degree 6+ years of hands-on relevant analytics/data science experience Minimum 4+ years of hands on SQL/ SAS programming experience & ability to leverage algorithms like Decision Tree, Regression and be efficient in handling complex/large data Must have experience with Business Intelligence and Reporting tools such as Tableau/Power BI Experience in campaign performance measurement, customer targeting framework and synergy of multiple functions & create / connect KPIs Proven ability to design and lead strategic projects and work independently, yet as key member and contributor to a broader team Be able to listen to the stakeholders, ideate/propose solutions, lead planning & execution, and deliver analytics projects Be able to effectively communicate (verbal, written & in presentation form) and lead analytics with senior stakeholders Experience in credit card or financial services industry Ability to effectively manage tasks and projects with competing priorities Desired Skills/Knowledge: Superior thought leadership and framework based solutioning abilities Innovative mindset that looks to improve current capabilities and discover new ones Eligibility Criteria: Degree in Statistics, Mathematics, Economics, Engineering, or any other quantitative streams with 4+ years of hands-on relevant analytics/data science experience, or in lieu of a degree 6+ years of hands-on relevant analytics/data science experience Work Timings: This role qualifies for Enhanced Flexibility and Choice offered in Synchrony India and will require the incumbent to be available between 06:00 AM Eastern Time - 11:30 AM Eastern Time (timings are anchored to US Eastern hours and will adjust twice a year locally). This window is for meetings with India and US teams. The remaining hours will be flexible for the employee to choose. Exceptions may apply periodically due to business needs. Please discuss this with the hiring manager for more details. For Internal Applicants : Understand the criteria or mandatory skills required for the role, before applying Inform your manager and HRM before applying for any role on Workday Ensure that your professional profile is updated (fields such as education, prior experience, other skills) and it is mandatory to upload your updated resume (Word or PDF format) Must not be any corrective action plan (First Formal/Final Formal, LPP) L8+ Employees who have completed 18 months in the organization and 12 months in current role and level are only eligible. L08+ Employees can apply Grade/Level: 10 Job Family Group: Data Analytics

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10.0 - 20.0 years

15 - 30 Lacs

Bengaluru

Hybrid

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Role : Name: Open Source Transition Lead Office : Client Deployed Mode : Hybrid Location : Banglore. Note: This role is an opportunity to Client Deployed model under EY payrolls. This is a initial duration of 6 months role, the tenure is subject to extension basis performance. Job Responsibility: • Transition from Sas to open source • Adopting R as open-source language Python • Scope is R&D wide ( 1000+ users) • Upskilling, right tools and program themselves and standard tools • Systems have Sas code and need to be decommissioned Big tech component • Business and Tech change • User engagement, comms, and training and getting voice of Customer (making training program. Please share ur updated resume to sai.m@in.ey.com

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3.0 - 5.0 years

7 - 11 Lacs

Noida

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XpertDox is a big-data healthcare start-up based out of Birmingham, AL, USA. We use advanced data analytics and proprietary natural language processing to structure, parse and map information from multiple diverse data sources. Its proprietary search engine and mappings are used to improve access to clinical trials and automate the coding process. We are seeking a SAS Programmer to become an integral part of our team! Responsibilities: SAS programming and debugging Creating automated SAS scripts and batch runs Perform QC on SAS batch exports Document all programming tasks and procedures Qualifications: Previous experience in SAS programming Familiarity with relational and non-relational databases Detail-oriented is a must Strong analytical and critical thinking skills

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6.0 - 7.0 years

5 - 8 Lacs

Hyderabad

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Role & responsibilities Developing, testing, validating, and maintaining SAS programs to generate analysis datasets, tables, listings, and figures Working closely with data management and statistical teams to understand the requirements for each project Reviewing clinical trial data and addressing any data inconsistencies or errors Designing and implementing strategies to manage, clean and verify clinical trial data Performing statistical analysis on clinical trial data Creating and maintaining documentation for all SAS programs and processes Ensuring that all programming activities and processes performed are conducted according to standard operating procedures and good programming practices Contributing to the development of standard operating procedures, guidelines, and best practices for SAS programming Assist with the development of statistical analysis plans. Provide input into clinical trial protocols and case report forms. Ensure data consistency and integrity. Meet project timelines and deliverables. Additional: Knowledge of CDISC SDTM and ADaM data models. Qualifications Proven work experience as a Clinical SAS Programmer. Experience in developing and validating SAS programs in a clinical research environment. Strong statistical analysis skills. Attention to detail and problem-solving skills. Proficient in the use of SAS Macro language and other advanced SAS features. Excellent written and verbal communication skills. BSc or higher degree in Statistics, Mathematics, Computer Science or a related field Interested Candidates please send me updated resumes to pitchireddy.t@hetero.com

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6.0 - 11.0 years

8 - 13 Lacs

Bengaluru

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Job Title: Senior Statistical Programmer II Career Level: D Introduction to role: Are you ready to take on a pivotal role in the development and validation of programs that create datasets conforming to Alexion and CDISC standards? As a Senior Statistical Programmer II, you will be at the forefront of crafting Tables, Listings, and Figures (TLFs) for analysis purposes. Depending on the projects size and complexity, you may lead programming efforts, ensuring alignment with ICH guidelines, Good Clinical Practices, and regulatory requirements. Youll also have the opportunity to mentor fellow programmers and represent Statistical Programming in meetings with internal and external clients. Are you prepared to integrate statistical concepts with SAS Programming efficiently and effectively? 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 principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, youll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients lives. With a rapidly expanding portfolio, youll have the chance to grow alongside a team that values diversity, inclusiveness, and the power of connection. Here, your career is more than just a path its a journey towards making a meaningful difference. Ready to make an impact? Apply now to join our team! Date Posted 02-Jun-2025 Closing Date 02-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.

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4.0 - 7.0 years

8 - 12 Lacs

Bengaluru

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This position is for a Manager with an advanced degree in a quantitative discipline; requires experience and proficiency in areas of statistics, applied mathematics, SAS programming language and a good understanding of retail banking / small business lending businesses. The individual will use these skills in the development of risk models (IRB, IFRS9, Custom Scorecards and others) and other risk analytics in retail banking / small business lending portfolios. Responsibilities include developing statistically derived predictive models, perform decision tree-based customer segmentation & profiling analyses, assist business implementation of sophisticated Regulatory and Scoring models and providing analytic support to Standard Chartered businesses across the globe. Key Responsibilities Competencies: Analytical / Strategic / Conceptual thinking Attention to detail Problem solving Verbal/Written communication Presentation skills Highly motivated, organized and methodical Regulatory & Business Conduct Display exemplary conduct and live by the Group s Values and Code of Conduct. Take personal responsibility for embedding the highest standards of ethics, including regulatory and business conduct, across Standard Chartered Bank. This includes understanding and ensuring compliance with, in letter and spirit, all applicable laws, regulations, guidelines and the Group Code of Conduct. Lead the [country / business unit / function/XXX [team] to achieve the outcomes set out in the Bank s Conduct Principles: [Fair Outcomes for Clients; Effective Financial Markets; Financial Crime Compliance; The Right Environment. ] * Effectively and collaboratively identify, escalate, mitigate and resolve risk, conduct and compliance matters. [Insert local regulator e. g. PRA/FCA prescribed responsibilities and Rationale for allocation]. [Where relevant - Additionally, for subsidiaries or relevant non -subsidiaries] Serve as a Director of the Board of [insert name of entities] Exercise authorities delegated by the Board of Directors and act in accordance with Articles of Association (or equivalent) Other Responsibilities Embed Here for good and Group s brand and values in XXXX [country / business unit / team]; Perform other responsibilities assigned under Group, Country, Business or Functional policies and procedures; Multiple functions (double hats); [List all responsibilities associated with the role] Skills and Experience Credit Risk Modelling Qualifications Bachelors / Advanced (Masters or higher) Degree in Statistics, Applied Mathematics, Operations Research, Economics, Engineering or other quantitative discipline Good understanding of retail banking / small business / consumer finance products and business life-cycles (e. g. sales, underwriting, portfolio management, marketing, collections) 1-4 in-depth years experience in hands-on Statistical Modeling in credit risk for retail banking / small business / consumer finance portfolios Proficient statistical programming skills in SAS (preferred) or similar, strong analytical skills and understanding of quantitative and statistical analysis Hands-on experience in mining data and understanding data patterns Experience in directly interacting with Business and exposure to International markets will be a plus About Standard Chartered Were an international bank, nimble enough to act, big enough for impact. For more than 170 years, weve worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If youre looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents and we cant wait to see the talents you can bring us. Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, youll see how we value difference and advocate inclusion. Together we: Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term What we offer In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing. Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations. Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum. Flexible working options based around home and office locations, with flexible working patterns. Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning. Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential. www. sc. com/careers 30346

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5.0 - 10.0 years

15 - 25 Lacs

Bengaluru

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Job Title: Senior SAS Programmer Experience: 510 Years Location: Bangalore (BLR) Notice Period: 0–30 Days Employment Type: Full-time Job Summary: We are looking for a Senior SAS Programmer with strong experience in clinical trial data programming. The ideal candidate will have expertise in SAS, SQL, and statistical reporting to support data analysis for clinical research studies. You will work closely with biostatisticians, data managers, and clinical teams to ensure the accuracy and quality of clinical trial outputs. Key Responsibilities: Develop and validate SAS programs to generate statistical summary tables, listings, and graphs (TLGs) . Create derived datasets for analysis using complex data manipulation techniques (e.g., LOCF, adverse events merging). Perform quality control (QC) on programs, datasets, and outputs. Support the development of Statistical Analysis Plans (SAPs) . Review CRFs and clinical databases for programming consistency. Compile and present clinical data reports and progress updates to the Biostatistics team. Import and process external data into analysis-ready formats. Participate in cross-functional team discussions to support clinical trial programming needs. Maintain detailed program documentation and contribute to internal QC and compliance processes. Required Skills: SAS (Base, Macros) SQL TLG generation Data derivation & transformation Clinical data standards LOCF, adverse event processing Experience with EDC systems Strong understanding of clinical trial design & data analysis Preferred: Experience in medical device clinical trials Familiarity with regulatory submission standards (e.g., CDISC, ADaM, SDTM) Soft Skills: Strong analytical and problem-solving skills Excellent communication and documentation abilities Attention to detail and quality focus Ability to manage timelines across multiple studies

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7.0 - 12.0 years

8 - 18 Lacs

Bengaluru

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Important Points to be noted here before you apply for this job:- 1. This is a 3rd Party Pay-roll opportunity, wherein, the Consultant will be on pay-rolls of Zentek Infosoft and working for the end client of Infosys. Apply ONLY if you are fine to work as a Sub Contractor on 3rd Party Pay-roll . 2. This is a LONG-TERM Opportunity with a Strong Chance of getting converted as Full Time Opportunity with Infosys after few months . 3. One round of Face-to-face Interview is a MUST for this role. 4. This is a Work from Office opportunity and person is expected to work from one of these offices of Infosys - Bangalore. This is NOT a Hybrid or WFH opportunity . We have Offshore Credit Risk requirements with SAS expertise , for Bangalore 7+ yrs SAS experience candidate who holds strong foundation SAS skills with hands-on experience. Min 7+ yrs hands on SAS development experience Strong base SAS foundation skills Worked in direct client facing role Candidate skills and skills mentioned on profile should be in sync : Technical as well Functional skills Good to have Base SAS certified and Banking domain exposure Number of Openings* -2 Duration of contract* - 12 Months+, Extendable after that and can be converted to Full Time after 12 months or sooner. Total Yrs. of Experience* - 7+ Relevant Yrs. of experience* - 7+ Detailed JD *(Roles and Responsibilities) Mandatory skills* - Credit Risk domain skills with SAS proficiency, SAS Enterprise preferably Work Location* - Bangalore Deep expertise and hands-on project experience on Credit Risk with SAS skills-based projects (SAS Enterprise preferably) in banking and financial services industry Ability to work as Techno-functional Business Analyst in client projects in financial services Risk domain Proven problem-solving and analytical skills, with hands on experience handling - SAS dataset, Excel spreadsheets/CSVs. SAS programming and development skills are a must have, to write SAS code, designing/ developing SAS applications, developing SAS macros, libraries, and templates etc. Proven communication and negotiation skills Ability to work with minimal supervision Ability to build and maintain good client relationship / work with multiple key stakeholders Exposure in working in agile methodology. Exposure in using industry accepted tools for agile methodology JIRA / Rally Total Exp at least 7+yrs Abhishek.Sharma@ZentekInfosoft.com

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8.0 - 13.0 years

6 - 11 Lacs

Kolkata, Mumbai, New Delhi

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Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, youll be at the heart of our clients innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical Biotech industry with a bachelor s degree or equivalent. At least 6 years of related experience with a master s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. Submissions experience utilizing define.xml and other submission documents. Experience supporting immunology, respiratory or oncology studies would be a plus. Excellent analytical troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change

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5.0 - 9.0 years

6 - 9 Lacs

Hyderabad

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What you will do Let’s do this. Let’s change the world. In this vital role you 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 six 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: 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 Project manage programming activities, according to agreed resource and timeline plans Ensure programming activities adhere to departmental standards and SOPs Write and/or review and approve 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 and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications Write, test, validate and execute department-, product- and protocol-level macros and utilities Oversee the work of outsourced resources assigned to projects 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 Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting 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: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Bachelor’s degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience Preferred Qualifications: Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model. Experience: Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Team management Global collaboration Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery Statistical programmingSQL required; SAS or R required; Python preferred Experience working 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 and lead role Expert statistical programming knowledge using SAS or R RequiredSAS or R RequiredSQL PreferredPython 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 epidemiologyIncidence 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 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

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15.0 - 20.0 years

5 - 9 Lacs

Bengaluru

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Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAS Analytics Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education1. Must Have Skills - SAS 9.x, SAS Viya, Windows, Linux, AIX, MAINFRAMEWe are looking for Admin2.Roles and responsibilities:SAS Environment Management:1. Install, configure, and upgrade SAS software (SAS 9.x, SAS Viya, etc.) across different platforms (Windows, Linux, AIX, etc.).2. Set up and maintain SAS metadata server, SAS object spawners, and SAS compute servers.3. Perform regular monitoring of SAS servers to ensure optimal performance, including resource usage and system load.4. Maintain and troubleshoot SAS environments to ensure they are secure, stable, and meet the business needs.System Administration:1.Manage user access and security permissions for SAS applications and platforms.2. Implement backup and disaster recovery procedures for SAS-related data and systems.3. Monitor and maintain the health of SAS servers, databases, and associated infrastructure.4. Coordinate and manage SAS system performance tuning, optimization, and problem resolution.Technical Support:1.Provide technical support to SAS users (Data Analysts, Data Scientists, Business Intelligence teams) by resolving software-related issues, troubleshooting errors, and ensuring seamless operation of the SAS platform.2. Troubleshoot and resolve issues related to SAS environment setup, installations, patches, and upgrades.System Upgrades & Patches:1. Plan and implement updates, patches, and upgrades to ensure that SAS systems are running the latest supported versions.Test and deploy new SAS software versions, ensuring backward compatibility with existing applications and workflows.Documentation & Reporting:1. Maintain clear documentation of SAS system configurations, environment setup, and troubleshooting procedures.Generate regular reports on system performance, user activity, and usage statistics to support decision-making processes.Collaboration & Training:3. Professional Attributes Excellent communication, Collaboration and Analytical Skills4.Shift Timing Shift B Qualification 15 years full time education

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2.0 - 7.0 years

7 - 11 Lacs

Ahmedabad

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Statistical Programmer II Location: Ahmedabad, Gujarat, India Requisition Number 690 On-site 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

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4.0 - 9.0 years

8 - 12 Lacs

Ahmedabad

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On-site 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 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.

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2.0 - 7.0 years

9 - 10 Lacs

Pune, Chennai, Coimbatore

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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.

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3.0 - 8.0 years

1 - 2 Lacs

Noida

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Job description Medtek is a data science driven company to support faster drug development and healthcare solutions.It support growing Biotech and Pharma companies. Assist clients with Data Technologies, Data Analysis, Data Mining, CDISC, Visualisation and Regulatory reporting. Support end to end Biostatistics, Programming and Data Management work. ESSENTIAL DUTIES AND RESPONSIBILITIES OF PRINCIPAL STATISTICAL PROGRAMMER- Able to independently Lead statistical programming activities for Phase 2/3 studies Able to multitask and work in a matrix environment 8 years experience in SAS programming and Reporting Able to program and deliver in independently with minimum guidance 6+ year of SDTM/ADaM and TLF Programming experience Able to write specification Independently validate others programs Able to work in multitasking environment and lead studies Proactive, multitask and able to work in matrix environment Pay attention to data and provide daily details Able to work in clinical domain with Clinician, Statistician and Scientist. In-depth knowledge of clinical trial design, statistical analysis, and regulatory guidelines. Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience Development and execution of statistical analysis and reporting deliverables (e.g.safety and efficacy analysis datasets, tables, listings, figures) Provide technical guidance to other statistical programmers, and ensure training and development of team members. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Master in Statistics, computer science or analytics field with 7+ year experience Knowledge/Skills: Eight + year of Statistical programming experience Six year of experience with CDISC Two year Experience with SQL programming Experience in CDISC SDTM/ADaM domain Good communication skills Job Type: Full-time Pay: 25-30 Lacs P.A. Schedule: 8 hour shift Application Question(s): Can you write ADaM, SDTM specificaiton and programs ? Experience: statistical programming: 7 years (Required)

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4.0 - 8.0 years

9 - 15 Lacs

Hyderabad, Pune, Bengaluru

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Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate 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 ( Pune ) Type : Job Code # 483 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 484 b) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 485

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5.0 - 10.0 years

15 - 20 Lacs

Nagpur, Bangalore Rural, Bengaluru

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Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 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 ( Nagpur ) Type : Job Code # 85 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 86

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