85 Adam Jobs - Page 3

Biostatistical Programming Manager What you will do Let’s do this. Let’s change the world. In this vital role you will Provide technical solutions to programming problems within CfOR Lead and develop technical programming and process improvement initiatives within CfOR Design data quality enhancements 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 Write and/or review and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications Write, test, validate and complete department-, product- and protocol-level macros and utilities Be responsible for 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 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. This crucial role involves leading a team of senior statistical programmers who will generate Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. This lead programming role will collaborate with teams across multiple time zones to oversee request fulfillment, clarify requirements, track projects, resolve issues, and deliver high-quality results. The Biostatistical Programming Manager will report to a locally based Director of Biostatistical Programming. The Biostatistical Programming Manager will be responsible for both hands-on programming as well as guiding junior programmers. Additionally, they will be responsible for manipulating large databases and generating reports to enable epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor’s degree and have at least six years of relevant career experience in statistical programming. Proficiency in SAS and SQL programming is required, while experience with R and Python is preferred. 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 Basic Qualifications: Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject. At least 6-8 years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting Preferred Qualifications: 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 Experience: Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials Team management Global collaboration Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery Statistical programmingSAS and SQL required; R and Python preferred Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies Hands-on programming and lead role Expert statistical programming knowledge using SAS or R RequiredSAS RequiredSQL RequiredExperience with data quality or data quality platforms (for exampleInformatica, Ataccama) PreferredPython PreferredR 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 Scientific / technical excellence Oral and written communication, documentation skills Leadership Innovation Teamwork Problem solving Attention to detail What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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.

Senior Statistical Programmer What you will do Let’s do this. Let’s change the world. In this vital role you will 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 Design data quality enhancements 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 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 implement 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 Senior Statistical Programmer will be responsible for hands-on programming and results delivery. Additionally, they will be responsible for manipulating large databases and generating reports to enable 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 SAS and SQL programming is required, while experience with R and Python is preferred. 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. Basic Qualifications: Bachelor’s degree with 3-5 years of experience in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject Preferred Qualifications: 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 Experience: 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 customer concern, results delivery Statistical programmingSAS and SQL required; R and 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 RequiredSQL PreferredPython PreferredR PreferredExperience with data quality or data quality platforms (for exampleInformatica, Ataccama) 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 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.

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 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 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 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)

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).

Key Responsibilities Develop and maintain autonomous agents using Python. Implement and integrate AI and LLM technologies into autonomous systems. Collaborate with cross-functional teams to design and develop innovative solutions. Analyze and evaluate the performance of autonomous agents and AI/LLM models. Grade and provide feedback on AI/LLM model results to ensure optimal performance. Stay updated with the latest advancements in AI, machine learning, and autonomous systems. Document development processes and technical specifications clearly. Troubleshoot and resolve issues related to autonomous systems and AI/LLM implementations. Required Skills And Qualifications Bachelor's or Master's degree in Computer Science, Engineering, or a related field. Proven experience in Python programming and software development. Strong understanding of AI, machine learning, and LLM concepts. Experience with AI frameworks and libraries such as TensorFlow, PyTorch, or similar. Ability to evaluate and grade AI/LLM model outputs accurately. Knowledge of autonomous systems and agent-based modeling. Excellent problem-solving skills and attention to detail. Strong communication and teamwork skills. Ability to work in a fast-paced and dynamic environment. Preferred Qualifications Experience with cloud platforms such as AWS, Azure, or Google Cloud. Knowledge of natural language processing (NLP) techniques and applications. Familiarity with robotics and control systems. Previous experience in developing autonomous systems or similar technologies.

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

Overview THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, The Phastar Discipline, has led us to build a reputation for outstanding quality. With this as our core focus, were looking for talented individuals who share our passion for quality and technical expertise to join our team. WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. Whats more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, youll also be helping to save the planet! THE ROLE We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment. This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year. Responsibilities Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Identify macros requirements, communicate and perform training Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc. Implement and coordinate development and maintenance of PHASTAR standard specifications Be an SDTM and ADAM expert providing consultancy, advice and training Be an CRT expert providing consultancy, advice and training Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements Implement and coordinate the development and maintenance of PHASTAR CRT tools Become familiar with and follow study documentation Initiating projects and ideas for furthering programming development Ensure the principles in the PHASTAR checklist are followed rigorously Develop archiving systems and processes Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery Liaise with Study Statistician and Project Manager regarding resourcing and deliverables Responsible for study level resources Attend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update processes and SOPs Qualifications Ability to lead Able to work on complex programming ISS/ISE experience preferred Have written complex macros. Educated to BSc or above within Computer Science, Mathematics or a Science related discipline APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team. WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet! THE ROLE Demand for our Functional Service Provision is growing, therefore we are looking for an experienced, ambitious and driven Programmer to join our FSP team The expectation is that the candidate has very strong CDISC knowledge. We're looking for a skilled QC expert with strong experience in ADaMs and TLFs, along with solid SDTM knowledge. This role requires independent work, client coordination, and proactive problem-solving. This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment. Responsibilities Employees may be required to perform some or all of the following: Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc Implement and coordinate development and maintenance of PHASTAR standard specifications Be an SDTM and ADAM expert providing consultancy, advice and training Be an CRT expert providing consultancy, advice and training Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements Implement and coordinate the development and maintenance of PHASTAR CRT tools Become familiar with and follow study documentation Initiating projects and ideas for furthering programming development Ensure the principles in the PHASTAR checklist are followed rigorously Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery Liaise with Study Statistician and Project Manager regarding resourcing and deliverables Responsible for study level resources Attend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are require QUALIFICATIONS & EXPERIENCE BSc or above in mathematics, science, or IT related discipline. Experience working on clinical trials within a CRO/pharmaceutical environment. Excellent proven end to end programming experience including SDTM, ADaM and TLFs with solid experience of validating/reviewing outputs Strong QC ability across ADaMs and TLFs predominantly but good SDTM experience needed Ability to work independently and link in with client for work assignments, updated FSP manager on progress/timelines/challenges and feedback QC comments to third party vendor Must be able to work autonomously as there is no overlap with client teams based in US for day-to-day communication. Has to feel comfortable prioritising tasks and being able to investigate issues and suggest solutions APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/ Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

THE ROLE Demand for our Functional Service Provision is growing we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with ISS / ISE and submission experience, who is versatile and flexible to work on various therapeutic areas. The successful individual must be able to program / QC ISS and ISE datasets, as well as TLFs – and will have experience with building macros and standards. This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment. This position is remote, and the successful candidate can be located anywhere in India. Responsibilities: Employees may be required to perform some or all of the following... Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc. Program complex non efficacy outputs/figures Develop and debug complex macros Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies Review simple study design SAP without supervision Review all shells without supervision and provide feedback Knowledge, interpretation and implementation of current SDTM, ADaM standards Knowledge of FDA CRT requirements including define.xml and define.pdf Become familiar with and follow study documentation Ensure the principles in the Phastar checklist are followed rigorously Archive study documentation following instructions in supplied SOPs Act as a Lead Programmer, ensuring quality and timely delivery Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables Assess and monitor study level resources Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Assist in development of internal training courses Qualifications: Educated to BSc or above within Computer Science, Mathematics or a Science related discipline 5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs) 5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential) ISS/ISE experience (essential) Excellent communication skills Good awareness of clinical trial issues, design, and implementation Familiarity with GCP and regulatory requirements Oncology experience is strongly preferred. Candidates without oncology experience must have prior experience working on complex efficacy studies. APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in India as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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

Location - Chennai ( Client location) Budget - 22L Experience- 8+yrs SO - 54925613 Open Position - 5 SAS Developer - 7+ years of experience as a SAS (Statistical Analysis Software) Programming Hands-on experience with BASE SAS, SAS/MACRO, SAS/STAT; Knowledge on CDISC Standards (must require SDTM and ADaM) Analysis & Reporting end to end process (must require TFLs generations as per sponsor standards) Expert in Relational Database systems (Oracle preferred) Advanced knowledge of software development lifecycle methodologies Strong understanding of importance of coding standards and programming style. Advanced ability to write software code (full stack development). Responsibilities Designs, modifies, develops, writes and implements software programming applications using SAS. Builds design and coding standards to ensure consistency across applications. Debugs problems with information systems using a variety of analytical skills, techniques, and resources Routinely communicates status (problems encountered, and time remaining to complete) to leadership team.

Top 3 skills: SDTM, Adam, TFL. Comm skill, Independent, proactive Interview: 3 Rounds Virtual Remote - India Contract duration - 1yr. Shift - General flexible.

Interested candidates may share their resume at heena.gill@iqvia.com Job Description : Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs • Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis • Support the electronic submission preparation and review • Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities • Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers • Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices • Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors • Independently leads and / or performs programming assignments with minimal supervision • Support improvement initiatives

Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. data validation guidelines),Develop SAS programs for ad hoc tables and listings, Required Candidate profile Design and set-up utilities/SAS based systems ,Carry out electronic data transfer (both incoming and outgoing),Review and interpret Report and Analysis Plans, Follow CDISC, FDA & other Guidelines

Job Description Summary -Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines. Role & responsibilities Major accountabilities: Lead statistical programming activities for several studies or drive the implementation of data analytics reports -Make decisions and propose strategies at study or project level. May act as functional manager for local associates including providing supervision and advice on functional expertise and processes. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), e.g. as representative in study or project-level team. Ensure project-level standardization -Provide and implement programming solutions; ensure knowledge sharing. Act as expert in problem-solving aspects. Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc -Leads/coleads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience: Biostatistics. Clinical Research Phases. R&D Portfolio Management. Statistical Programming. Data Management & Systems. Regulatory Submissions. Innovative & Analytical Technologies. Clinical Trial Design, Data Review & Reporting. Skills: Classification Systems. Clinical Trials. Computer Data Storage. Computer Programming. Cross-Functional Teams. Data Analysis. Data Structures. Initiative. Programming Languages. Reporting. Statistical Analysis. Languages : English.

We are seeking an experienced ADaM, SDTM Implementation Expert with a strong background in statistical programming and clinical data standards. The ideal candidate will support biostatistical analysis by providing ADaM datasets tailored for analysis and have experience with python or Gen AI in processing SDTM data and ADaM data analysis. Location: India, Remote Job Type: Full-time Experience Required: 5+ years Job Description: Must Have: 5+ years of experience in ADaM and SDTM implementation. Strong background in statistical programming and clinical data standards. Experience in supporting biostatistical analysis by providing ADaM datasets. Proficiency in Python and SQL for data handling and automation. Ability to program and validate derived datasets, statistical tables, listings, and figures (TLFs). Ensure statistical traceability from raw data to final analysis outputs. Experience in transforming clinical trial data from its raw, collected format (SDTM) into ADaM. Develop and implement SDTM and ADaM datasets in compliance with CDISC standards. Develop and maintain data pipelines, processing semi-structured, structured, and unstructured data. Experience in clinical trial data management and regulatory submissions. Experience with containerization (Docker, ECS, Kubernetes). Proficiency with SQL and NoSQL databases such as PostgreSQL, MySQL, and DynamoDB. Excellent to Have: Experience in designing, training, and fine-tuning Generative AI models (LLMs, GANs, VAEs, Diffusion Models). Ability to design and optimize prompt strategies for LLMs (GPT, Claude, Llama, Mistral, etc.). Strong understanding of LLMs, diffusion models, and generative techniques. Required Knowledge: Strong knowledge of CDISC standards, FDA guidelines, and define.xml. Ensure security best practices for AWS and Azure applications and infrastructure. Familiarity with metadata-driven programming. Knowledge of machine learning or advanced statistical modeling in a clinical research setting. How to Apply: Interested candidates can apply by sending your resume to Shyamala.gunde@excelra.com.

Job Job Title SAS, Python, Base SAS Certified, Advanced SAS Certified Responsibilities SAS, Python, Base SAS Certified, Advanced SAS Certified Preferred Skills: Technology->sas->sas Technology->Machine Learning->Python Educational Requirements Bachelor of Engineering Service Line Data & Analytics Unit * Location of posting is subject to business requirements

Job Description Job Title: Senior Statistical Programmer Employment Type: Full time Location: Bengaluru / Remote Experience: 2-5 Years Primary Responsibilities Produces statistical analysis using SAS/R according to relevant standard operating procedures. Ensuring compliance to SOPs Programming analysis dataset without a specifications Delivers the assigned tasks and projects within agreed timelines and quality standards Developing SAS Programs for the statistical analysis of study data, including analysis of datasets, tables, listings, and figures Programming according to CDISC SDTM and ADaM datasets Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines. Preparing and performing internal training on statistical programming processes and techniques Make certain that indication or project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs Provide guidance, mentoring, training for junior team members and help solve issues from cross-functional teams Represent ClinChoice/Department during internal and external audits Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group. Reporting issues to the Project or Study leads or Supervisors in an appropriate time frame Responsible for continuous development of own skills according to Individual development plan. Actively present in knowledge-sharing meetings, ask questions and share feedback to improve the process or standards of the programming continuously. Proactively communicate and collaborate with the global team by understanding the time zone differences. Conducts other statistical programming activities as required Conduct other administrative and departmental activities as needed Secondary Responsibilities: Behavioral Competencies and Skills Professional Intellectual capability Trustworthy Action Orientation Personal Growth Prioritization Quality focused Active Listening Personability Willingness to learn Team Player Stress Management Learning Agility Result Driven Timely Feedback Candidate Profile Bachelors degree or equivalent required, preferably in life science, statistics, computer science, or related subjects. Should have a minimum of 4+ years of experience within the pharmaceutical industry. Good experience within the pharmaceutical industry with clinical programming and clinical development processes of across therapeutic areas. Good knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis the requirements for clinical programming projects. Good knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc. Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc. Good written and verbal communication skills, collaborations, and interpersonal

Role & responsibilities Candidate should have minimum of 8 years of experience - clinical SAS programmer Atleast 5 years of experience as SAS programmer with SDTM, ADAM and TLF. Preferred candidate profile Perks and benefits

Role & responsibilities Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. MUST HAVE Skillsets: Work experience in a SDTM and ADAM programming Experience with R Data Structures in R (metrices, vectors), creating datasets using data frame Date formatting and character functions in R Experience List of packages exposed like DPLYR, TIDYVERSE, HAVEN, ADMIRAL, LUBRIDATE, STRINGR etc. Experienced with functions like Summary, Count, Mutate, Paste, Paste0. Experience in GGPLOT2 Experience in R-Shiny, R Markdown, Statistical Models are optional Experience in creation of ADaM Datasets for Safety and efficacy domains. Perks and benefits: Remote opportunity based on requirement Cab facility for Hybrid employees