208 Sdtm Jobs - Page 8

Location Bengaluru, Karnataka, India Job ID R-227172 Date posted 19/05/2025 Job Title: Associate Director - Statistical Programming Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Career Level: E – Individual Contributor position. 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! Date Posted 20-May-2025 Closing Date 30-Jul-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. ]]>

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. sdtm programmer Program mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for? sdtm programmer sdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Any Graduation,BE,BTech Show more Show less

Job Title: Principal Statistical Programmer Experience: Minimum 12 year of experience as clinical SAS programmer Location: Hyderabad Job Type: Full-Time Professional Summary: The Principal Statistical Programmer is responsible for leading and developing high-quality programming that support sponsors research programs at an expert level. In addition, the Principal Statistical Programmer has an active role in continuous improvement and is expected to act as a leader in the department. Roles and Responsibilities: Follow the department and company standard operating procedures (SOPs), policies, and standards. Provide feedback and update these guidelines as needed. Using SAS, perform SDTM, ADaM, and table, figure, and listing (TFL)programming, quality control (QC) review, and create documentation of programs used in creating statistical outputs. May perform role of Lead Statistical Programmer on studies, portions of studies, or programs. Act as expert in programming and Clinical Data Interchange Standards Consortium (CDISC) deliverables. Understand regulatory agency standards and provide final deliverables in accordance with these standards (i.e., final CDISC deliverables for studies to be included in Food and Drug Administration [FDA] submissions). Collaborate with Lead Biostatisticians and the study team to resolve any study-related questions and ensure that programming outputs represent the statistical analysis plan (SAP) and raw data from external sources and the clinical database. Perform peer review and take accountability for ensuring programming accurately reflects the raw data. Follow current SDTM standards and current ADaM Implementation Guides. Lead studies and/or study-related programming activities. Perform review of the clinical database in regard to visit naming, Clinical Data Acquisition Standards Harmonization (CDASH), and accurate data collection to provide clinical data that is analyzable and meets the needs of the Biostatistics team. Understand timelines and milestones affecting work. Create Biostatistics deliverables that follow the protocol and SAP. Understand and update SAS programs to adapt to various study situations and perform self-review to ensure outputs are as expected. Accurately import external data to be used in TFLs. Reconcile external data and provide findings for non-reconcilable items to the Data Management team. Interact with other staff members to understand and explain SAS programs accurately. Provide technical expertise for internal and external clients and independently bring project solutions to the Biostatistics team and other departments. Analyze existing processes and explore improvement solutions. Develop and lead in intradepartmental or interdepartmental process and quality improvement initiatives. Perform and plan the development, implementation and validation of new process technologies, macros, and applications. Oversee direct reports as assigned. Mentor and train programmers or other team members and/or develop training materials as needed. Other tasks as requested. Educational Qualification: Bachelor's Degree in programming, health-related sciences, or relevant field. Skills: Good to have R programming knowledge and experience. Excellent verbal and written communication skills. Professional attitude and strong interpersonal skills. Ability to work well with a multi-disciplinary team of professionals. Client-focused approach to work. Flexible attitude with respect to work assignments and new learning. Ability to prioritize workload. Superior attention to detail. Understanding of clinical research and the relationship of Data Management in the clinical study process. Proven history of continuous improvement. Successful management or mentoring experience of direct or indirect reports. Strong technical aptitude and ability to adapt to multiple data management platforms. Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to multiple information technology (IT) systems Role & responsibilities Preferred candidate profile

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 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 291 a) For Position in Pune Search : Job Code # 292

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Lead Profile. Job Description: Minimum 9 + years of experience with Pharmaceutical or CRO industry engaged in Clinical and Preclinical Research Good understanding of applied statistical principles and modeling in the design and analysis of clinical studies Good understanding of ICH and regulatory guidelines Experience in CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming. Good communication and interpersonal skills Experience in handling domain interactions with the customer. Preferred Educational Qualification for the role: Masters or Doctorate level degree in Biostatistics, Statistics, Mathematics or related fields . Essential Experience for the Role : Good knowledge and hands on experience in R and SAS Statistical Programming in Clinical Domain To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Hyderabad Search : Job Code # 294 b) For Position in Chennai Search : Job Code # 295 c) For Position in Indore Search : Job Code # 296

Minimum 5+ years of experience In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.) Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc. In-depth knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (e.g., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, etc.) to support ongoing clinical data and safety review IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Location Chennai, Tamil Nadu, India Job ID R-220063 Date posted 14/05/2025 Job Title - EDC IT Platform Engineer Career Level - D1 Introduction to role Are you ready to make a difference in the world of medicine? AstraZeneca is seeking an EDC IT Platform Engineer to join our R&D IT: EDC Product Engineering Team. You'll play a crucial role in managing, improving, and maintaining our EDC product, Medidata’s Rave, which is GxP compliant and integral to our Clinical Development Platforms. Collaborate with multi-functional teams, including IT Product Leads, DevOps Leads, and business teams, to support the EDC Product across all therapeutic areas. Accountabilities Facilitate key discussions with partners and provide SME technical support on system improvements and testing of the Core EDC Product and data integration tools. Participate in the validation lifecycle for upgrades, changes, and new integrations. Perform risk assessments during change implementations and system upgrades. Conduct impact analysis for changes on the EDC system. Support code review and solutioning for downstream customer requirements, including data extraction methods. Co-develop validation packages following standard operating procedures. Create and complete GxP Validation Test cases in Jira Xray for system and regression testing. Resolve day-to-day incidents and service requests, aiming for incident reduction and automation. Facilitate process requirements gathering and adhere to AZ core ITIL guidelines. Maintain the Rave URL(s) and its integrations. Essential Skills/Experience Extensive experience using Medidata RAVE UI (Classic or Rave EDC) for study build, edit checks programming, deployment, and migration. Understanding of core configuration, clinical views, roles, permissions, and data extraction capabilities/tools in Rave. Hands-on experience with Inbound Rave Web Services, Rave safety gateway setup, SAS extracts, and Target Source Data Verification (TSDV). Experience with URL upgrades (Medidata release notes review and upgrades). Knowledge of system validation processes and Application Life Cycle Management. Experience in clinical standards, data collection, conversion, or programming/testing. Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology, and FDA/ICH guidelines. Effective partner management and communication skills. Desirable Skills/Experience Experience with custom functions, SAS programming, Coder/Coder+ setup, Lab setup. Experience with outbound Rave Web Services and Rave backend data model. Knowledge of agile management tools like Service NOW. Experience in system testing including authoring and implementing test cases. Passion for learning and delivering valuable software. Knowledge of other Medidata products and/or Cloud. EDC testing experience (Rave/Inform/Veeva). 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, we leverage technology to impact patients' lives directly. Our global organization is purpose-led, pushing the boundaries of science to discover life-changing medicines. We empower our teams to innovate with ground breaking technology platforms and data analytics. Join us at this pivotal stage as we transform into a digital and data-led enterprise. Here, you can explore new solutions in a dynamic environment that encourages lifelong learning and innovation. Ready to take on this exciting challenge? Apply now to be part of our journey! Date Posted 15-May-2025 Closing Date 29-Jun-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. ]]>

Let’s do this. Let’s change the world. In this vital role you will collaborate with teams across multiple time zones to fulfill requests, clarify requirements, escalate issues, and deliver high-quality results. The Sr Associate Biostatistical Programming will report to a locally based Biostatistical Programming Manager. The Sr Associate Biostatistical Programming will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least four years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential. Responsibilities: Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications Provide technical solutions to programming problems within CfOR(Centre for Observational research). Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Manage all programming activities, according to agreed resource and timeline plans Ensure all programming activities on the project adhere to departmental standards Write and/or review and approve all programming plans Write and/or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test, validate and execute department-, product- and protocol-level macros and utilities Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings Participate in the recruitment of programming staff Actively participate in external professional organizations, conferences and/or meetings Provide input to and participate in intra-departmental and CfOR meetings Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) Manage staff performance and oversee staff assignments and utilization What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree and 1 to 3 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Bachelor’s degree and 3 to 5 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR Diploma and 7 to 9 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience Preferred Qualifications: Experience in SQL, and statistical programming using SAS or R Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy Global collaboration on studies to clarify and implement analyses described in Statistical Analysis Plans Project fulfillment, statistical programming, issue escalation, results delivery Statistical programmingSQL required; SAS or R required; Python preferred Motivated to learn how to work with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies Hands-on programming role Expert statistical programming knowledge using SAS or R 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 Learning mindset What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com

What you will do Let’s do this. Let’s change the world. In this vital role you will Guide and support junior team members by offering technical advice, conducting code reviews, and sharing knowledge to promote their professional development Provide technical solutions to programming problems within CfOR Lead and develop technical programming and process improvement initiatives within CfOR Represent the programming function and participate in multidisciplinary project team meetings Project manage all programming activities, according to agreed resource and timeline plans Ensure all programming activities on the project adhere to departmental standards Write and/or review and approve all programming plans Oversee the work of outsourced resources assigned to project Lead and/or participate in the development and review of CfOR Policies, SOPs and other controlled documents 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 Enhance and support existing R Shiny applications with a focus on front-end improvements Provide support for the Atlas web-based application from the OHDSI community Develop and implement web solutions using HTML, CSS, and JavaScript Collaborate with stakeholders to understand their requirements and translate them into technical solutions Implement CI/CD processes to ensure efficient and reliable deployment of applications Manage and optimize data workflows to support efficient data processing and analysis Stay updated with R programming trends and integrate new technologies as needed Establish coding standards and best practices for R package and R Shiny development Optimize performance and refactor code to enhance efficiency and reliability Validate and test software tools What we expect of you We are all different, yet we all use our unique contributions to serve patients. Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in programming projects and Experience in R Shiny, HTML, CSS, and JavaScript. Basic Qualifications: Bachelor's degree in Computer Science, Information Technology, or a related field At least six (6) years of relevant experience in full stack development Preferred Qualifications: Master’s degree in Computer Science, Information Technology or other relevant scientific subject Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model Experience working with the OHDSI community and supporting Shiny applications Familiarity with Real-World Evidence and its applications in observational studies Experience: Developing and maintaining web applications using R Shiny Supporting and enhancing web-based applications in a collaborative environment Collaborating with multi-functional teams to deliver technical solutions that meet user requirements Global collaboration Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery Key Competencies RequiredProficient in R and R Shiny (Intermediate) RequiredHTML (Expert) RequiredCSS (Expert) RequiredJavaScript (Expert) PreferredPython (Intermediate) Git workflows using version control Continuous Integration and Continuous Deployment (CI/CD) 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, Market Scan, Optum, PharMetrics, Flatiron, Medicare OMOP common data model Scientific / technical excellence Oral and written communication, documentation skills Leadership Innovation Teamwork Problem solving Attention to detail Learning attitude 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 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.

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Business Advisory New Associate Qualifications: BE/BTech/Bachelor of Information systems and Management Years of Experience: 0 to 1 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.sdtm programmerProgram mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for? sdtm programmersdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Bachelor of Information systems and Management

Location: Bengaluru, India Job reference: R-226537 Date posted: 05/13/2025 Job Title: Statistical Programmer II Career Level: C Introduction to role: Are you ready to make a difference in the world of biopharmaceuticals? As a Statistical Programmer II, you'll play a crucial role in developing and validating programs that create datasets conforming to Alexion and CDISC standards. Your work will be pivotal in generating Tables, Listings, and Figures for analysis purposes, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll be part of a dynamic team, contributing to moderate scope and medium complexity studies or drug projects. With guidance from experienced programmers, you'll have the opportunity to enhance your skills in SAS programming and statistical concepts while collaborating across functions to drive continuous improvement. Accountabilities: Support development of technical programming specifications for SDTM, ADS, or ADaM standards under guidance. Develop and validate programs for generating SDTM datasets, analysis datasets, and tables, listings, figures/graphs based on Protocol and SAP. Understand protocols and clinical development plans to contribute effectively. Ensure high quality in deliverables within established frameworks. Work independently on well-defined scopes of work. Acquire knowledge of the drug development process and industry standards. Increase proficiency in SAS and understand roles within clinical study teams. Collaborate with external vendors and contract programmers. Provide updates on project progress and support leadership in implementing department standards. Contribute ideas for optimizing standard operating procedures. Essential Skills/Experience: 2 to 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Ability to understand development and validation of technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Collaborative problem-solving skills. Clear communication with management and team members. Basic competence in using SAS/Base, SAS/Macro, SAS/STAT, or other statistical computing software. Basic understanding of relational databases and good programming practices. 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, we fuse science and data to develop bold solutions that positively impact patients' lives. Our environment encourages curiosity and innovation, allowing you to explore new methodologies and models that drive scientific breakthroughs. With a focus on collaboration across therapy areas, you'll have the opportunity to grow your expertise while contributing to meaningful research that makes a tangible difference globally. Ready to take the next step in your career? Apply now and become part of our dedicated team at AstraZeneca! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database • Responsible & Accountable for the assigned study conduct activities, in clinical trials • Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. • Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. • To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). • SPOC for the study communications • Proactively highlight any risks associated with the study along with the mitigation plan. • Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. • Identify process Improvement opportunities and ensure learning is shared • Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. • Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. • Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 C) For Position in Bangalore Search : Job Code # 186

Hi, We are hiring for Leading ITES Company for Lead Study Data Manager Profile Skills: a) Minimum 5 Years of Core Clinical Data Management Experience with minimum 1 year of experience of leading a clinical trial. . b) Experience on Study Conduct and Close Out c) Any Graduate JOB DECSRIPTION: Need exposure of Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and to ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customer. are completed with the expected quality. Have worked on Study set-up, Study Conduct and Study Close out for various therapeutic areas. Have also worked on writing edit check specification, CRF completion guidelines and review and corrections of set up documents for different versions. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 184 b) For Position in Pune Search : Job Code # 185 c) For Position in Bangalore Search : Job Code # 186

Hi We are Hiring for the ITES Company for the position of SAS : Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, 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, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. 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, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : Statistical Programmer Nagpur (Job Code # 210) b) For Position in Bangalore Search : Statistical Programmer Bangalore (Job Code # 211)

Hi We are Hiring for the ITES Company for the position of SAS: Statistical Programmer Job Description: We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, 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, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. 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, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)

Hi We are Hiring for Leading ITES Company for the role of Statistical Programmer Job Description : We are looking for an associate with at least 5 - 10 years of experience for Statistical programming position, 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, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. 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, architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. SAS Developer with over 5+ years of experience with expertise on different domains. Possess solid ability in integrating programming skills, adapting to new applications and expertise in architecting Data Preparation, Data Visualization, Data Integration, Analytical Reporting. Worked on different SAS tools like SAS Data Integration, SAS Studio, SAS EG, SAS Management Console. Experience in ETL Preparation, data exploration, data preparation, data cleansing, reporting, and technical document preparation. Import /Export data using various techniques like PROC IMPORT, PROC EXPORT, LIBNAME, INFILE, PROC PRINT statements. Good Knowledge of Data management, Data handling, and Creating Data structure Knowledge of Database languages such as MYSQL, Oracle. Knowledge of various SAS Procedures like PROC Means, PROC Freq, PROC Contents, PROC Import, PROC Format, Proc Summary, PROC Sort, PROC Transpose, and PROC Report. Knowledge Of SAS procedures like SAS/Base, SAS/Macro, SAS/SQL, SAS Arrays, Do loops, SQL Joins, Hash join techniques Generating ABT and RBT tables for predictive modeling. Co-ordinate with team members to create repositories, data connections, and data jobs. Having Basic Knowledge of SAS Anti-Money Laundering like Data Model, Understanding Different Scenarios, Mapping. Good Knowledge of understanding client requirements, gathering requirements, reducing requirement error, and contributing to the team to deliver quality solutions on time and within budget. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : Statistical Programmer Nagpur (Job Code # 210) b) For Position in Bangalore Search : Statistical Programmer Bangalore (Job Code # 211)

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 and Follow the Steps Below: a) For Position in Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209)

Job Description :SAS Programmer ABOUT GLENMARK Glenmark Pharmaceuticals Ltd. is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities, 4 research and development centers, spread across 5 continents and operations in over 80 countries. Glenmark is ranked among the world's top 100 biopharmaceutical companies (Top 100 Companies Ranked by Pharmaceutical R&D and Sales, 2022, by In Vivo/Scrip 100) and among the world's top 50 companies in the Generics and Biosimilars (Top 50 Generics and Biosimilars Companies ranked by Sales, 2022, by Generics Bulletin/In Vivo). The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year. For more information, visit www.glenmarkpharma.com POSITION DETAILS: Business Unit: Research & Development Function: SAS Programming Location: Mahape, Navi Mumbai Reporting to: Sanjay Jankar, Sr. General Manager, Biometrics ROLE OVERVIEW/ PURPOSE Perform all Bio-statistical and SAS programming activities. OVERALL JOB RESPONSIBILITIES Develop CDISC related documentation ex aCRF, mapping specs. Be the lead programmers for the outsourced studies Develop Analysis Datasets and TLG for the internal studies Update project related documentation regularly. Provide support to data management /Clinical in developing listings or ad hoc reports as required. Other SAS programming related tasks assigned by line management. KEY RELATIONSHIPS/STAKEHOLDERS External Vendors Internal (other than Direct Reports) Data Management Team CRA DB Programmer Medical team DESIRED EXPERIENCE AND KNOWLEDGE Educational Qualifications Bachelor or Master Degree required, any statistics/biostatistics degree preferred Experience: 10-14 year's clinical trials in pharma or CRO. In depth SAS programming knowledge. Hands-on experience on multiple CDISC projects (10 or more studies) and Written Reviewers Guide with CDISC package. Working knowledge with SDTM/ADaM/XML Familiarity with statistical methods used for biomedical/pharmaceutical research required; Experience with clinical trials or pharmaceutical industry experience required Knowledge of current industry and regulatory submission practices, protocol designs, and terminology. Knowledge and Skills (Functional / Technical) Excellent SAS programming (Base SAS + Advance SAS + SAS STAT + SAS Graph) Proficiency in English language Good Interpersonal Skills Time Management Training and Mentoring Presentation Skills Adaptability Strategic Thinking Decision Making Comfort with Computer system usage Behavioral Attributes Team Player Other Requirements (License / Certification & Specialized Training) ICH-GCP

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

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

We are hiring for Clinical SAS Programmer/ Statistical Programmer for permanent Remote Opportunity. Experience in clinical domain 7 to 10 Years. 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 specification 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) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs Thanks & Regards, Avinash Pathak Mount Talent , India, USA, Singapore, Dubai avinash.pathak@mounttalent.com | Cell: +91-9717118333 Website www.mounttalent.com Consulting | Technology LinkedIn: linkedin.com/in/avinash-kumar-pathak-b44656b3

Job Description: Experience in clinical domain 7+ Years Ephicasy life science Permanant Remote opportunity If interested please share resume at manjeet.kaur@mounttalent.com 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 specification 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) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs

Clinical SAS Programmar EPHICASY LIFESCIENCE PAN INDIA (Remote Opportunity) Exp 6 to 14 years If anyone interested please share resume at manjeet.kaur@mounttalent.com Roles and Responsibilities Below is the JD required for this role. Experience in clinical domain 7+ Years 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 specification 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) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs Please share some relevant profiles from CRO domain. Knowledge of and experience in application development and quality management lifecycles. Recognized expertise in SAS programming and SAS macro code development. Demonstrated knowledge of and experience in the application of CDISC data and standards, primarily ADaM but also SDTM, define XML etc. Simple Programs which can be answered in any language or flowchart or algorithm. The Clinical SAS Programmers should have good SAS programming skills, knowledge of Clinical Trials domain, should be willing to learn other new concepts and technologies.

Job Description Experience in clinical domain 5+ Years (Relevant to SDTM,ADAM and TLF 5years required out of 7 years) 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 specification 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) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs Anyone interested please share resume at manjeet.kaur@mounttalent.com

Experience in clinical domain 6+ Years 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 specification 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) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs Role & responsibilities Preferred candidate profile Perks and benefits