126 Cdisc Jobs - Page 4

Job Overview: Serve as a member of the project team with primary responsibility for conducting the clinical data review, query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets. Assist in the development of the project Data Management Plan, including data review guidelines /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements. Summary of Responsibilities: Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Demonstrates capability to read and follow study timelines for on-time deliverables. Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted. Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data. Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data. Generate, resolve and track queries to address problematic data identified during aggregate data review activities. Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required. Generate and QCs data listings for internal data review. May assist or create dummy data to test edit checks and to test database screen design and functionality. Assist or create dummy data to test SAS reports and data listing. Demonstrates the ability to review Edit Check Specifications and Database specifications. Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required. Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request. Assist with the completion of Database Lock and Unlock activities. Supports the training of new staff on project specific Data Management processes. Performs any other duties as assigned. Qualifications (Minimum Required): University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. Fluent in English, both written and verbal. Experience (Minimum Required): 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas. Demonstrated time management skill and ability to adhere to project productivity metrics and timelines. Knowledge of medical terminology is preferred. Knowledge of effective clinical data management practices. Knowledge of science or a scientific background is preferred. Good oral and written communication skills. Demonstrate time management skill and ability to adhere to project productivity metrics and timelines. Demonstrate ability to work in a team environment and collaborate with peers. Demonstrate good organizational ability, communication, and interpersonal skills. Demonstrate team working skills and good collaborator skills. Demonstrate a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

Biostatistician cum Statistical Programmer Job Description Performs biostatistical and SAS programming activities for given clinical trials involving Novel, Biosimilar and PMS studies. As a Biostatistician cum Statistical Programmer youll work on a variety of projects, while collaborating with our cross-functional team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. You’ll also contribute to research design and analytical strategies, provide input into protocols, Statistical Methodology and develop and review statistical analysis plans. As a Statistical Programmer, you will leverage your SAS programming skills to support Phase I-IV clinical trials. with expertise in CDISC implementation (SDTMs, ADaMs) & TFLs, and experience in Regulatory Submissions as a part of the Statistical Programming, will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions. Responsibilities • Provide SAS programming support to all clinical projects (Phase 1 to 4). Manage programming CROs providing oversight for programming deliverables. Create programming related SOPs, as necessary. Works in tandem with CRO' s Biostatistics and SAS Programming and Data Management teams on various clinical projects. • Provide statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for integrated reports). • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming. Applying your SAS programming skills, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s). Generating complex ad-hoc reports for publications. • Reviews/Develops SAS macros, templates and utilities for data cleaning and reporting. Reviews/ analyses specified in the protocol or the Statistical Analysis Plan (SAP) is implemented while working with the biostatisticians. • Reviews CRF annotations and data specifications & discuss data structures and participate in data review activities. • Provide input into statistical programming solutions and/or ensure their efficient implementation. In consultation with the Biostatistician, responsible for reviewing of programming specifications of analysis datasets and pooled datasets. • Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. • Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance. Performs quality control on final reports. Ensures the accuracy of statistical programming components of scientific reports and/or publications with high quality. • Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives Technical / Functional Skills Knowledge of applied parametric and non-parametric statistics, Mixed Model. Missing Data analysis, General Linear models - ANOVA, ANCOVA, t-test, etc Non-Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression. Strong SAS/R programming Skills in R software. Advanced SAS and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Good Knowledge of CDISC implementation (SDTMs, ADaMs) Minimum requirements • Master degree in statistics with Ideally 4+years of work experience in a programming role preferably clinical trials/ or in pharmaceutical industry or CROs. • Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides Provide technical leadership and mentorship to global programming teams Collaborate closely with biostatistics, data management, and regulatory affairs teams Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards Required Qualifications: Bachelors or Masters degree in Statistics, Computer Science, or a related field 10+ years of SAS programming experience in clinical research or pharmaceutical industry Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis Deep understanding of CDISC standards, regulatory compliance, and submission requirements Prior experience in oncology, neuroscience, or immunology domains preferred Proven leadership capabilities in managing cross-functional and global teams Excellent communication, project management, and problem-solving skills Preferred Tools & Skills: SAS (Base, Macro, STAT, Graph) Familiarity with SDTM/ADaM IG, FDA submission standards Understanding of regulatory submission formats (eCTD) How to Apply / Schedule an Interview: Send your details via WhatsApp or Call : Puja- (8250242229) in the following format: Full Name: Mobile Number: Email Address: Highest Qualification: Total Experience: Current Organization: Preferred Location: Current CTC: Expected CTC: Notice Period: Note: If the line is busy, please drop a WhatsApp message and we will get back to you at the earliest. Referrals Welcome! Know someone who fits the bill? Share this post and help them grow their career! You & I Consulting Your Career Growth Partner

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 preferred. 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.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Statistical Programming Manager to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Provide support to project teams on programming matters; Manage programming staff, coordinate task assignments and review activities/progress to ensure high quality delivery; Provide leadership and training for the Programming group; Ensure all projects within the team meet objectives and timelines; and Lead the development of Programming standards, applications and processes to maximize efficiencies. Qualifications Bachelor/Master degree in statistics, mathematics, health informatics, computer science, or related field; Proficiency in SAS programming skills; 5 years of clinical programming experience; Strong communication skills and coordination skills; and Good leadership skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Senior SAS Programmers to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Propose and develop specifications for new projects and serve as a project team leader Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Responsible for the setup, validation and maintenance of mapped databases, integration of external data with associated edit checks, writing programs independently with good quality for use in creating analysis datasets, tables, listings, and figures. Responsible for mapped database setup, validation and maintenance, and external data integration & edit checks, validation, and maintenance Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field 5+ years' eperience with SAS Excellent knowledge of CDISC standards SAS Certification Thorough understanding of the pharmaceutical industry and Federal Regulations regarding electronic records Excellent analytical, written and oral communication skills Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

TCS is hiring for Statistical Programmer!!! Job Location Mumbai/Pune/Bengaluru Experience Range 4 to 14 Years Educational Qualification(s) Required Any Life Science Graduate Interested can share their CV on babeeta.shahi@tcs.com Roles & Responsibilities:- Creation and validation of analysis data sets, tables, listings and figures . Creation and validation of ISS and ISE reports. . Development and testing of reusable Standard Programs . Development of SAS macros to work as utilities to automate routine activities . Remapping of old studies into ADaM structure . Build and maintain ADaM compliant Repository . Creation and validation of ADaM specification document . Assistance in creation of regulatory submission documents

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

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

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

Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Nagpur ) Type : Job Code # 85 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 86

Hi , We are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 83 b) To Apply for above Job Role ( Pune ) Type : Job Code # 84

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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 91 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 92

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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 84 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 85 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 86

Hi We are looking to hire for SAS+R Programming . Please go through the JD and Apply Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge 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. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 373 b) For Position in Pune Search : Job Code # 374

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge 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. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 375 b) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 376

Hi We are hiring for Leading ITES Company for SAS+R Programmer Profile. Role & responsibilities: a) Any Graduate b) Minimum of 3 years of experience in SAS + R programming c) Familiarity with data visualization techniques and tools in R d) CDISC knowledge & experience Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge 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. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 373 b) To Apply for above Job Role ( Pune ) Type : Job Code # 374

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Programming in Clinical Domain To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 291 b) To Apply for above Job Role ( Pune ) Type : Job Code # 292

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

Our Team About the job Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally, Main Responsibilities The Associate Biostatistician will work with Medical Affairs biostatisticians and Sanofi Business Operations biostatistics and programming personnel to support and implement statistical analysis plans and provide QCd data packages including tables, figures, and listings for use in publications (i-e abstracts, posters, oral, presentations, and manuscripts); The Associate Biostatistician will ensure SOPs are followed and timelines and quality metrics are met, People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs, Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data 2) Support in Design, develop, test, implement, and document statistical programming in high-level software packages e-g SAS 3) Produce well documented data packages that include tables, listings, and figures 4) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team 5) Review appropriate biomedical and clinical research literature related to assigned project(s), Customer: 1) Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables, About You Experience: Master's degree with 1-3 years (m-sc ) of experience required /Ph D in biostatistics or statistics or epidemiology and 1-2 years, Soft skills: Ability to manage timelines and Ability to work independently and within a team environment, High proficiency in statistical methods used in the pharmaceutical industry?, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines, Technical skills: Base and / or Advance SAS programming skills, SDTM & ADaM (CDISC) and other statistical computing software skills in a clinical data environment across multiple indications in a therapeutic area, Education: Master of Science degree or equivalent in Statistics/ Ph D in biostatistics or statistics or epidemiology Languages: Excellent English language knowledge written and spoken Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi ! null

Role & responsibilities '' Immediate Joiners Preferred '' Role : Senior Statistical Programmer Location : Hyderabad Experience : Minimum 7 years as Clinical Statistical Programmer We are looking for Senior Statistical Programmer who is responsible for designing, developing, and implementing complex statistical programming solutions to support clinical trial data analysis. This role involves collaboration with cross-functional teams, including Biostatistics, Clinical Data Management, and Regulatory Affairs, to ensure high-quality and timely data deliverables. The Senior Statistical Programmer is expected to handle programming activities for clinical studies and may provide guidance to junior programmers. Key Responsibilities Act as programming lead on Phase I-IV group of studies. Leading the studies and acting as the POC for multiple studies. Perform programming activities for a trail indication. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with SDTM Implementation Guide, project standards, and the study protocol. Perform CDISC activities in accordance with corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other regulatory requirements. Develop/Validate SAS analysis datasets (ADaM) and prepare tables, listings, and figures as per specifications, SAP and Mockshell. Creates programs to prepare graphs and tables that are required in clinical study reports, safety reports, efficacy reports, etc., ensuring on-time quality delivery. Perform CRF annotation and Specification creation as per CDISC standards. Validate tables, listings, and figures as per client required Mockshells. Supporting database QC activities. Support client and internal audits. Validate and transform datasets as per client specifications. Validate tables, listings, and figures as per client required specifications. Ability to work on data migration from legacy datasets to standards such as CDISC and client specific requirements. Communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs. Co-ordinate with the client regarding data issues, outliers, reviews, etc. Provide CDISC training, guidance, and project leadership to team members. Education & Qualification M.Sc. Statistics, Bachelors/Masters degree in Life Sciences, B. Tech (Any stream) and B. Pharmacy/M. Pharmacy Skills Strong written and oral communication skills and time management skills Ability to effectively prioritize and execute tasks in a high-pressure environment. Ability to work independently, take initiative and complete tasks to deadlines. Ability to work in a team-oriented, collaborative environment. Ability to work positively within a continually changing environment. To be determined in achieving goals Ability to manage multiple projects under tight timelines Knowledge & Experience Strong knowledge of global clinical trial practices, procedures, development process, and clinical trial data flow Knowledge in TLF’s Knowledge in Data Analysis using SAS Knowledge in Generating DEFINE.XML and Reviewers Guides for regulatory submissions. Preferred candidate profile

Hi , We are hiring for Leading ITES Company for R Biostatistical Programmer Profile. Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Programming in Clinical Domain To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 291 a) For Position in Pune Search : Job Code # 292

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

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