178 Sdtm Jobs - Page 6

Job Title: Clinical SAS Programmer Career Level: CL11 (3+ years) / CL10 (5+ years) Domain: Life Sciences Location: Koramangala, Bangalore Work Mode: Work from Office (No WFH) Shifts: Flexible / Rotational Job Description: We are looking for experienced Clinical SAS Programmers to join our Life Sciences team. The ideal candidate will have strong hands-on experience in Clinical SAS, including Macros and Proc SQL, and a solid understanding of clinical trial processes. Key Responsibilities: Perform data analysis using SAS programming techniques as per project requirements. Develop and maintain SAS Macros and programs using Proc SQL. Work with clinical trial data to support statistical analysis and reporting. Collaborate with cross-functional teams to ensure accurate and timely delivery. Adhere to standard operating procedures (SOPs) and regulatory compliance. Be open to working in rotational shifts as per business needs. Required Qualifications and Skills: 3+ years of relevant Clinical SAS experience for CL11 level. 5+ years of relevant Clinical SAS experience for CL10 level. Strong knowledge of SAS Macros and Proc SQL . Understanding of clinical trial methodologies and regulatory guidelines. Must be willing to work from the office (Koramangala, Bangalore) No WFH option. Flexible to work in shifts as per project requirements.

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 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 Statical 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

Position Summary: The Database Programmer II is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Qualifications: Minimum Required: Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline 3 years' experience in clinical database programming Bachelor's and/or a combination of related experience Medidata Rave EDC Rave API integration experience using external vendor modules Good to have Rave Advanced Custom Function programming experience Other Required: Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of clinical research tasks. Excellent organizational and communication skills Professional use of the English language; both written and oral. Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) Experience in clinical database management system development. Experience in a clinical, scientific or healthcare discipline. Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong leadership and interpersonal skills Must be able to communicate effectively in the English language. Preferred: Oncology and/or Orphan Drug therapeutic experience Base SAS®, SAS/STAT and SAS/ACCESS software SAS Macro programming language Advanced experience in Database Management, object-oriented programming Veeva set up experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 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 Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 91 b) For Position in Nagpur Search : Job Code # 92

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

Job responsibilities • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required Qualifications What were looking for • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English.

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 and Follow the Steps Below: a) For Position in Pune Search : SAS + CDB Programmer Pune (Job Code # 84) b) For Position in Mumbai Search : SAS + CDB Programmer Mumbai (Job Code # 83)

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 and Follow the Steps Below: a) For Position in Mumbai Search : SAS + CDB Programmer Mumbai (Job Code # 83) b) For Position in Pune Search : SAS + CDB Programmer Pune (Job Code # 84)

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 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

Hi, We are hiring for ITES Company for SAS + CDB Programmer Role. Job description: Programming, specifically J Review, SQL, R and GitHub. Good to have Python. • Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. • Develop library of reusable checks working closely with data engineers and config specialists. • Collaborate with cross functional teams in creating business rules and automated check library across TAU. • Serves as a technical resource for creating data analytics to help with data validation and cleaning. • Provide programming expertise for data cleaning to efficiently ensure high quality data. • Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. • Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. • Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. • 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.) • Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable • Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), • EDC build and/or clinical data management experience preferred • Experience in AWS preferred • Experience setting up automated validation is preferred • Knowledge of Data base and creating interactive Dashboards are preferred • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Key Skills: a) Minimum 3 years of Experience in SAS CDB Programmers with R programming. b) Good to have Python knowledge c) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Pune Search : Job Code # 84 b) For Position in Nagpur Search : Job Code # 85 c) For Position in Bangalore Search : Job Code # 86

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 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 Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 91 b) For Position in Nagpur Search : Job Code # 92

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)

Education/Language: BTech MTech Master of Science degree in Computer Science and/or equivalent work experience Good verbal and written communication skills Professional Skills & Experience: Minimum of 3-5 years of experience in implementing end to end business intelligence using Qlik Sense. Thorough experience in Qlik Sense architecture, design, develop, test and deployment process. Thorough understanding of Qlik Sense best practices (re-usability, efficiency, optimization). Knowledge on Clinical Datasets and Standards is a plus. (eg: SDTM, CDISC (92,45,101), Q Format, Customized Data formats ..etc). Excellent understanding of relational database concepts, data modelling, and design. Excellent knowledge on writing SQL code and ETL procedures using MS-SQL Server. Strong Software Development Lifecycle experience (Agile methodology experience is a plus). Strong technical project management experience and team leadership skills including scope management, work planning and work delegation. Strong troubleshooting skills and use of defect/feature management systems. Proven ability to work independently and with technical team members (Startup environment experience is a plus). Good verbal and written communication skills. Strong analytical skills and strong decision-making capabilities. Technical Skills & Experience 3+ years of experience in Qlik Sense architecture and design 3+ years of experience in develop, test and deploy of Qlik Sense applications. 3+ years with SQL Server and ETL process. 3+ years with Data modelling (physical & logical). Experience with Performance tuning and best practices of Qlik Sense. Experience with Dimensional modelling, Star Schema and Snowflake Schema. Knowledge of clinical trial data and SDTM standards is a plus.

Education/Language: BTech MTech Master of Science degree in Computer Science and/or equivalent work experience Good verbal and written communication skills Professional Skills & Experience: Minimum of 3-5 years of experience in implementing end to end business intelligence using Qlik Sense. Thorough experience in Qlik Sense architecture, design, develop, test and deployment process. Thorough understanding of Qlik Sense best practices (re-usability, efficiency, optimization). Knowledge on Clinical Datasets and Standards is a plus. (eg: SDTM, CDISC (92,45,101), Q Format, Customized Data formats ..etc). Excellent understanding of relational database concepts, data modelling, and design. Excellent knowledge on writing SQL code and ETL procedures using MS-SQL Server. Strong Software Development Lifecycle experience (Agile methodology experience is a plus). Strong technical project management experience and team leadership skills including scope management, work planning and work delegation. Strong troubleshooting skills and use of defect/feature management systems. Proven ability to work independently and with technical team members (Startup environment experience is a plus). Good verbal and written communication skills. Strong analytical skills and strong decision-making capabilities. Technical Skills & Experience 3+ years of experience in Qlik Sense architecture and design 3+ years of experience in develop, test and deploy of Qlik Sense applications. 3+ years with SQL Server and ETL process. 3+ years with Data modelling (physical & logical). Experience with Performance tuning and best practices of Qlik Sense. Experience with Dimensional modelling, Star Schema and Snowflake Schema. Knowledge of clinical trial data and SDTM standards is a plus.

Responsibilities: Develop and validate SAS programs to transform, analyze, and report clinical trial data in accordance with SDTM and ADaM standards, study protocols, statistical analysis plans, and regulatory requirements. Generate SDTM datasets from raw clinical trial data and ensure compliance with CDISC standards and company-specific conventions. Develop ADaM datasets for statistical analysis, including efficacy and safety endpoints, and generate associated TLFs. Collaborate with biostatisticians, data managers, and other team members to ensure the accuracy and integrity of clinical trial data. Perform quality control checks on SAS datasets and outputs to identify and resolve data discrepancies or inconsistencies. Generate tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions, and other project deliverables. Support ad hoc data requests and analyses from internal stakeholders, including clinical operations, medical affairs, and regulatory affairs teams. Contribute to the development and maintenance of standardized SAS macros and programming libraries to improve efficiency and consistency across projects. Stay informed about industry trends, best practices, and emerging technologies in clinical SAS programming. Key Skills: SDTM, ADaM, TLF'S, Efficacy, PK/PD, ISS/ISE Qualifications: Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field. 3-12 years of experience as a SAS programmer in the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Proficiency in SAS programming, including data step, PROC SQL, PROC REPORT, and macro programming. Experience working with SDTM and ADaM datasets, as well as familiarity with regulatory guidelines (e.g., ICH-GCP).

Education/Language: BTech MTech Master of Science degree in Computer Science and/or equivalent work experience Good verbal and written communication skills Professional Skills & Experience: Minimum of 3-5 years of experience in implementing end to end business intelligence using Qlik Sense. Thorough experience in Qlik Sense architecture, design, develop, test and deployment process. Thorough understanding of Qlik Sense best practices (re-usability, efficiency, optimization). Knowledge on Clinical Datasets and Standards is a plus. (eg: SDTM, CDISC (92,45,101), Q Format, Customized Data formats ..etc). Excellent understanding of relational database concepts, data modelling, and design. Excellent knowledge on writing SQL code and ETL procedures using MS-SQL Server. Strong Software Development Lifecycle experience (Agile methodology experience is a plus). Strong technical project management experience and team leadership skills including scope management, work planning and work delegation. Strong troubleshooting skills and use of defect/feature management systems. Proven ability to work independently and with technical team members (Startup environment experience is a plus). Good verbal and written communication skills. Strong analytical skills and strong decision-making capabilities. Technical Skills & Experience 3+ years of experience in Qlik Sense architecture and design 3+ years of experience in develop, test and deploy of Qlik Sense applications. 3+ years with SQL Server and ETL process. 3+ years with Data modelling (physical & logical). Experience with Performance tuning and best practices of Qlik Sense. Experience with Dimensional modelling, Star Schema and Snowflake Schema. Knowledge of clinical trial data and SDTM standards is a plus.

KEY TASKS & RESPONSIBILITIES Determine resourcing needs per project load, deadline requirements and resource utilization Create or review and approve programming plans at study and project level Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plans, SAPs, etc.) Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials Assist Biostatisticians by suggesting algorithms to address novel analysis requests Develop analysis datasets for trial level reporting and integrated safety and efficacy activities Program and QC data listings, summaries and Graphs as defined in SAP Develop re-usable utility macros to build a macro library to support programming tables, listing and graphs for all phases of clinical trial reporting Create submission ready SDTM and ADaM datasets following standard industry processes Performs peer review of all SAS Programmers deliverables Serve as Subject Matter Expert for Statistical deliverables and lead task forces to develop complex, technical solutions for projects or business needs Collaborate with the project team and other Professional Services Managers to ensure the deliverables are completed on time with high quality Develops and maintains good working relationships with internal cross functional teams and Clients Develops, revises, and maintains Standard Operating Procedures and Work Instructions. Assists in the training of Standard Operating Procedures and Work Instructions. Maintain all project documentation as required by SOP and Processes Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures May serve as Lead Statistical Programmer on projects when needed Other duties as assigned

The job responsibilities include two roles Project Standards Manager (PSM) will manage the activities associated with the consistent implementation of global clinical data standards for BMS projects and studies Global Standards Manager (GSM) will assist in the leadership of the development and maintenance of BMS s global clinical data standards and related supportive processes Each individual can perform PSM, GSM or a combination of the two roles. Development, maintenance and Implementation of BMS clinical data Standards Participate in the development and maintenance of global clinical data standards, including operational (CRF and non-CRF) CDISC Study Data Tabulation Model (SDTM), controlled terminology, non-CRF standard data mappings (e.g., lab or ECG), and other applicable industry standards. This could include creation of the metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard. Participate in relevant study team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, Programmed edit checks, Data transfer specifications, SDTM mapping specifications and SDTM annotated CRF. Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology. Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from industry standard software tools and BMS custom validation programs. Work with standards management systems and software, such as Metadata Repository, Change Request systems, SDTM validation systems, and issues tracking systems, in the development of systems and processes for creation and maintenance of data standards, including specifications, mappings between standards, and checking adherence to these data standards. Coach CROs and vendors on BMS data standards and related processes Communicate and reinforce content and interpretation of BMS data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project. Standards Governance Organization and submissions support Process clinical data change requests for new or existing metadata, including developing a Standards manager recommendation and implementation plan for the standard, as applicable, and ensuring that the request is processed through the appropriate levels of the CDSGO Participate in the committees of the CDSGO, partner with functional area stewards, organizing standards topics to be reviewed and ensuring decisions are made in a timely manner, documented in meeting minutes and other forms, and implemented. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation. Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer s Guide, XPT files). Participate in Study / Submission team meetings, as applicable. Other Key Activities Participate in the development of CDSI or cross functional SOPs, Working Procedures, Guidance documents, and job aids. Participate in the identification, review, evaluation, and implementation of new technologies related to data standards. Develop training materials and provide training on CDS-developed processes. May coach more junior personnel or contract staff, as required Participate in strategic initiatives, special projects, and working groups contributing to business decisions and process changes Identify and propose process improvements while maintaining a strategic focus. Share new industry standards, best practices with project and study teams, and within department as required. Degree Requirements Bachelor s degree required Experience Requirements At least 7 years of relevant industry experience with clinical trials, preferably with clinical data standards as a focus. Experience in Industry Standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models. Experience with Medidata Rave(EDC) and Metadata Repository (MDR) is preferred. Experience interpreting Health Authority regulations with a strong compliance background. Strong working knowledge of the overall pharmaceutical development process. Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml. Experience in CRF design, query resolution, and general data validation. Good communication skills, high ability to communicate standards related issues, options, and their impact to project teams and within department. Ability to work effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 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 Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Indore Search : Job Code # 228 b) For Position in Ahmedabad Search : Job Code # 229