178 Sdtm Jobs - Page 7

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more careers bms com/working-with-us Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

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.

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

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.

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms com/working-with-us Senior Managers of Statistical Programming provide comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data Senior Managers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams Senior Managers of Statistical Programming also support and lead improvement initiatives They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making Senior Managers also lead and support the change management process (e g communication, training, stakeholder engagement) This position may include functional management responsibilities In this role, Senior Managers of Statistical Programming are responsible for managing employees: set objectives, manage performance, and provide meaningful coaching and feedback They also support the evaluation and recruitment of potential employees If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Responsibilities BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more careers bms com/working-with-us Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

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

Roles and responsibilities: 1) Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Oncology Therapeutic area is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs

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 Data Cleaning and Manipulation Develop and execute complex SAS programs to generate analysis datasets, tables, listings, and figures according to the Statistical Analysis Plan (SAP) and study protocol. Perform statistical analyses on clinical trial data using appropriate SAS procedures, including descriptive statistics, hypothesis testing, and regression analysis. Perform statistical analyses on clinical trial data using appropriate SAS procedures, including descriptive statistics, hypothesis testing, and regression analysis. Conduct data quality checks to identify and resolve data discrepancies, ensuring data integrity throughout the analysis process. Create clear and concise clinical study reports, including tables, listings, and figures, for interim and final analysis, adhering to regulatory standards. Work closely with biostatisticians, data managers, clinical trial teams, and other stakeholders to design analyses, interpret results, and address data issues. Interested to apply can share CV or call/WhatsApp to 8438813362 Preferred candidate profile Bachelors or Master's degree in biostatistics, statistics, or a related field Minimum of 0-2 years of experience in clinical SAS programming Strong understanding of statistical analysis methods Experience working with clinical trial data. Excellent SAS programming skills Proficient in data manipulation techniques Strong communication and interpersonal skills Ability to work independently and as part of a team. 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

As Director of Clinical Data Management, where you will be instrumental in shaping the Clinical Data Management (CDM) strategy for either specific therapeutic areas/indications or at a strategic level within the DM organization. You will play a crucial role in our Oncology R&D team, ensuring high-quality CDM, overseeing external partnerships, and achieving metrics for the CDM function. This role offers the opportunity to influence decision-making with cross-functional teams and foster a culture of achieving milestones with utmost customer satisfaction. Accountabilities: As Director of Clinical Data Management, you will provide leadership for assigned projects, assuming global accountability and serving as the primary point of contact at the project level. You will demonstrate operational expertise in strategic planning and the delivery of CDM objectives across projects. Responsibilities include managing vendor contracts, resource allocation, budget oversight, and ensuring optimal vendor performance for studies. Proactive risk management and issue resolution related to CDM improvements or technology are also key aspects of the role. Essential Skills / Experience: Bachelor's degree in life sciences, pharmacy, nursing, or a related field. Proven ability to manage multiple trials simultaneously and meet deadlines. Extensive experience in Clinical Data Management, ideally in both CRO and Pharma settings across multiple therapeutic areas. Strong understanding of clinical trials methodology, GCP, GDMP, and medical terminology. Proficiency in clinical standards such as SDTM or CDASH. Exceptional attention to detail and a robust analytical mindset. Outstanding interpersonal skills with demonstrated effectiveness in a global environment. Excellent written and verbal communication skills, including negotiation, collaboration, conflict management, and interpersonal interactions. Cultural awareness and ability to work effectively in diverse teams. Experience in CRO and vendor management. Leadership experience in managing teams and overseeing large Phase III trials or multiple smaller trials. Familiarity with SQL, 4GL, VBA, or R software. Experience with Regulatory Inspections and knowledge of Project Management practices. Additional Qualifications: Project Management training or certification.

Role Overview: Domnic Lewis has been mandated to hire a Senior Statistical Programmer II to be a part of the Early Biometrics & Statistical Innovation (EB&SI) team. In this role, you will provide advanced statistical programming expertise to support the design and interpretation of early-phase clinical studies and development programs. You will work closely with either the Cardiovascular/Renal/Metabolism (CVRM) or Respiratory & Immunology (R&I) teams, contributing to data-driven decision-making and the scientific utilization of data for the company's products. This role will allow you to innovate and apply creative statistical approaches while working with cutting-edge technology. As part of the Data Science and AI team, you will have access to advanced tools and the opportunity to advance your career through various paths, including technical specialization, global project management, or leadership roles. Key Responsibilities: Statistical Programming Support: Provide statistical programming support for clinical study data analysis and reporting, including Clinical Study Reports (CSRs), regulatory submissions, and other scientific applications. Programming Leadership: Lead and manage programming activities across the analysis and reporting process to ensure high-quality and timely deliverables. Programming Standards & Tools: Contribute to the development and maintenance of programming standards and analysis tools across the global team. Cross-Functional Collaboration: Work closely with cross-functional teams to ensure that statistical programming aligns with study objectives and regulatory requirements. Innovation and Continuous Improvement: Drive innovation in statistical programming and foster a culture of continuous improvement. Essential Skills & Experience: Proven experience in statistical programming within the pharmaceutical or healthcare industry. Strong understanding of technical and regulatory requirements related to statistical programming. Ability to manage multiple tasks efficiently and solve problems collaboratively in a team-oriented environment. Desirable Skills & Experience: No additional specific experience required.

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

1)Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop, Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs

Hi We are Hiring for the ITES Company for the position of SAS: Statistical Programmer Location : Mumbai/Pune/ Nagpur/Bangalore 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) C) For Position in Nagpur Search : Statistical Programmer Nagpur (Job Code # 210) d) 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. Location: Mumbai, Pune, Nagpur & Bangalore Salary: Upto 15 LPA 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) C) For Position in Nagpur Search : Statistical Programmer Nagpur (Job Code # 210) d) For Position in Bangalore Search : Statistical Programmer Bangalore (Job Code # 211)

Hi We are Hiring for Leading ITES Company for the role of Statistical Programmer Location: Mumbai/ Pune/Nagpur/ Bangalore 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 Mumbai Search : Statistical Programmer Mumbai (Job Code # 208) b) For Position in Pune Search : Statistical Programmer Pune (Job Code # 209) C) For Position in Nagpur Search : Statistical Programmer Nagpur (Job Code # 210) d) For Position in Bangalore Search : Statistical Programmer Bangalore (Job Code # 211)

Hi, We are hiring for the ITES Company for the Trial Statistician Role. Job Description Develop documents e.g. - Clinical Trial Protocol (CTP) - Trial Statistical Analysis Plan (TSAP) - Randomization specifications & initiate randomization scheme creation Participate in the development of Integrated Quality and Risk Management (IQRM) plan and MQRP Support Trial Data Manager (TDM) - Review the data management plan (DMP) and data collection specifications distributed by TDM - Support treatment assignment in SDTM - Provide input to and review Data Review Plan (DRP) prepared by TDM Participate and provide input in meetings (e.g., Trial Oversight Meeting (TOM), organized by CTL; investigators meeting Create and maintain documents in BDS TMF Plan, handle and communicate about trial-specific statistical topics and issues e.g., Sample Size Calculation, Statistical Analysis Strategy Organize and chair Result Planning Meeting (RPM), prepare and participate in the Result Alignment Meeting (RAM) Support TPROG for TSAP implementation and statistical QC of programs, Finalization of QC/Validation. Participate in preparation of Clinical Trial Report (CTR) Handle unexpected data after final data delivery Wrap-up TOM Specify non-CTR specific analyses, Planned/Ad hoc data delivery during trial conduct, e.g. interim analysis Support electronic submission Data delivery at final trial closure, Give input to public disclosure of clinical trial results (CT.gov, EudraCT, etc.) Key Skills: a) Qualification: statistical background (B.Sc. & M.Sc. Statistics) b) Should have experience in Sample size, Biostatistician, Mock shell, Sample sizing calculation, Statistical Analysis Plan(SAP), Statistics c) Knowledge of Clinical Trial Protocol, Clinical Trial Report To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) Search : Job Code # 77

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 Pune Search : Job Code # 93 b) For Position in Mumbai Search : Job Code # 94

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