126 Cdisc Jobs - Page 5

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 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 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 Bangalore Search : Job Code # 375 b) For Position in Hyderabad Search : Job Code # 376

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 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 375 b) For Position in Hyderabad Search : Job Code # 376

We are hiring for Clinical SAS Programmer/ Statistical Programmer for permanent Remote Opportunity. Experience in clinical domain 7 to 10 Years. 1) Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials 2) Experience creating and working with Utility Macros 3) Experience creating specification 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs Thanks & Regards, Avinash Pathak Mount Talent , India, USA, Singapore, Dubai avinash.pathak@mounttalent.com | Cell: +91-9717118333 Website www.mounttalent.com Consulting | Technology LinkedIn: linkedin.com/in/avinash-kumar-pathak-b44656b3

Experience in clinical domain 6+ Years 1) Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials 2) Experience creating and working with Utility Macros 3) Experience creating specification 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs Role & responsibilities Preferred candidate profile Perks and benefits

Hiring for Clinical SAS Programmer for Noida Any Grad/PG -5 Yrs Of exp In Clinical SAS Programming ,SDTM,ADAM ,TLF, Pinnacle 21 Max -7 yrs In Clinical SAS Programming /Statistical Programming Call@ WhatsApp- Kajal - 8595849767/Vishakha -8287990567

Primary Job Function Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities. In collaboration with the Biostatistician and Senior Programmer, provide programming support to project-level programming deliverables and other adhoc programming requests. Roles and Responsibilities Ensure understanding and compliance with study and project programming standards. Responsible for development of programming specification. 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. Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards Trouble-shoot and resolve programming issues in a timely and efficient manner. Ability to work independently and as part of a team environment. Strong problem solving and organizational skills, attention to detail, verbal and written communications skills Desired Candidate Profile Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS). Good communications and negotiation skills, ability to work well with others globally.

Hi , We are hiring for Leading ITES Company for Data Management Study Point of Contact (DMSPOC) Profile. Job Description: To provide end to end data management services and project management of studies. Ensure compliance with SOPs and training. Primary point of escalation for issue management. Accountable for DM deliverables (including quality and timing) on the project and will be required to provide regular status updates on data completeness, cleanliness to the Data Manager. Point of contact for client POC. Attend meetings with Study Lead Data Manager (SLDM) as and when required, provide inputs to the required documents and activities throughout the course of the trial. Ensure that the timelines & quality are met as per study requirement. Resource estimation for the study and ensuring right resources are available for the study based on requirement. To oversight the end-to-end data management activities for assigned studies. Risk identification, mitigation and issue escalation to the appropriate stakeholders. Skillsets required: Ability to represent Data Management at all levels and is capable of targeting information to the respective audience. Ability to influence key project roles or Study Team members to meet the overall goal of the study. Ability to build influential networks with client and stakeholder management. Ability to develop solutions for cross functional challenges. Develops recommendations beyond own area of expertise. Knowledge of ICH GCP & CDISC requirements. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 297 b) For Position in Pune Search : Job Code # 298 c) For Position in Bangalore Search : Job Code # 299

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

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 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 375 b) For Position in Hyderabad Search : Job Code # 376

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

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

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

Role Purpose: We are seeking a skilled and proactive Clinical Biometry IT Administrator to manage and support our Biometry systems including SAS Server/PC, R studio, CDISC tools, QlikSense tools. The ideal candidate will have hands-on experience with R, SAS, CDISC, Study Data, system integrations, a strong understanding of GCP & 21CFR part 11 compliance, Knowledge of Clinical Trials and a passion for optimizing Biometry operations through technology including AI. Role & responsibilities Understanding and knowledge of specific Biometrics software like SAS and R. Preferably has worked with these languages. Ability to Write R and SAS programs, De-bug. Knowledge of R Studio (R Connect, R Workbench, R Package Mgr) Knowledge of SAS Server and SAS PC Strong hands-on experience in Documentum D2 (preferably D2 4.x and above) and D2 Life Sciences modules. Configure Documentum D2LS components including workspaces, widgets, forms, lifecycles, workflows, and security models. Experience with validating R packages. Knowledge of SAS, R program validation. Demonstrate competency to install, upgrade and maintain a Statistical Computing Environment for SAS server & PC, R Studio, LSAF, Entimice or similar. Knowledge of Unix scripting, robocopy commands, Python scripting Good to have knowledge of Jenkins, Code Commit Experience with version control systems plus supporting clinical CI/CD processes and data automation pipelines. Understanding and experience of version control of R, SAS programs and use of tools like with GitLab. Experience to work in a ICH GCP environment and FDA 21CFR part 11 requirements Experience implementing and maintaining computerized systems in GCP environments (Development, validation and production environments) Knowledge of system validation approaches (risk-based validation, CSV documentation) Understanding and experience with CDISC standards ADaM, SDTM. Hands on technical knowledge of data conversions, De-bug issues. Supporting tools like Pinnacle and RYZE. Understanding and experience of Integrations of Biometrics system with File shares via Globalscape/SFTP, external Clinical EDC and Lab systems. Good to have - Knowledge of visualization tools like QlikSense, Tableau. Build and configure new Qlik Apps, maintain existing apps. Knowledge of data migrations of Biometry systems and verifications. Support data/document migration activities from legacy systems to D2LS. Able to implement and support biometry systems by issue resolution, bug fixes, User access management, Enhancements, Upgrade, maintain adequate storage for File shares, maintain the integrations Functional Knowledge of clinical trails and study conduct and data analysis & submission in early and late phase clinical studies. Good to Have Knowledge of AI Predictive/Generative/Agentic

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all written and authorized SOPs and/or work instructions. - Understand data structures, e.g, CDISC, LOINC - Experience of SAS programming to produce derived analysis datasets. - Collaborate with internal departments to make sure data is collected, managed and reported clearly, accurately and securely. - Support client and internal audits. - Takes on mentoring newer Data Management team members.

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all written and authorized SOPs and/or work instructions. - Understand data structures, e.g, CDISC, LOINC - Experience of SAS programming to produce derived analysis datasets. - Collaborate with internal departments to make sure data is collected, managed and reported clearly, accurately and securely. - Support client and internal audits. - Takes on mentoring newer Data Management team members.

- Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all written and authorized SOPs and/or work instructions. - Understand data structures, e.g, CDISC, LOINC - Experience of SAS programming to produce derived analysis datasets. - Collaborate with internal departments to make sure data is collected, managed and reported clearly, accurately and securely. - Support client and internal audits. - Takes on mentoring newer Data Management team members.

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.

Designation: Clinical Data Manager Full Time Opportunity Location: Full Time Job Description: - Tasks have been carried out independently and the status is communicated back to all relevant parties. - Ensuring that the electronic data generated is transferred to the customer as per the Data Specifications - Configure, QC, and Test Study EDT and obtain client sign off on approved DTS. - Ensure EDT is delivered in accordance with the required frequency and specifications. - Control the receipt and integration of partner or 3PL data, as per scope of study. - Perform data reconciliations within the context of the assigned team, [and service], as appropriate to ensure a clean data set. - Perform approved data cleaning functions in order to maintain a clean data set. - Adherence to all written and authorized SOPs and/or work instructions. - Understand data structures, e.g, CDISC, LOINC - Experience of SAS programming to produce derived analysis datasets. - Collaborate with internal departments to make sure data is collected, managed and reported clearly, accurately and securely. - Support client and internal audits. - Takes on mentoring newer Data Management team members.

Job purpose: The Clinical Data Manager is a key member of Ocugens clinical data management team. This individual will be responsible for ensuring quality data collection and management processes, CRF development, database design, data monitoring, and validation of entered data for clinical development, and/or marketed products. This individual will work closely with the Biometrics team and the rest of the team at Ocugen to execute the data collection needs of the research studies. Duties and responsibilities: Establishes data flow from collection to final analysis through a data management plan. Ensures the accurate collection of electronic data. Collaborates on implementation and collection of data supporting for research protocols. Develops data transfer specifications and data review specifications and/or data quality review plan specifications. Develops program standard and study-specific electronic Case Report Forms (eCRFs). Develop and revise SOPs, implement DMP and strategies. Develop and implement risk management strategies. Prepare and participate in Audits. Develops edit checks, validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensure all required documentation is completed in a timely manner. Lead junior Data management staff. Collaborates with other functional teams to ensure proper output of clinical data as needed for deliverables. Additional tasks and projects as requested. Qualifications : BS degree in clinical, biological or mathematical sciences, or related field or nursing qualification, or work- related equivalent. 6+ years direct clinical data management experience in pharmaceutical development or CRO environment. Experience with clinical trials. Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection. Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. Experience in working with USA biopharmaceuticals/pharmaceuticals companies or client. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions : This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.

THE ROLE Demand for our Functional Service Provision is growing, therefore we are looking for an experienced, ambitious and driven Programming Manager to join our FSP team The expectation is that the candidate has very strong CDISC knowledge with ability to line manage . We're looking for a skilled QC expert with strong experience in ADaMs and TLFs, along with solid SDTM knowledge. This role requires line management, client coordination, and proactive problem-solving. This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment. Responsibilities: Employees may be required to perform some or all of the following: Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Coordinate and perform code reviews Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Identify macros requirements, communicate and perform training Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc Implement and coordinate development and maintenance of PHASTAR standard specifications Be an SDTM and ADAM expert providing consultancy, advice and training Be an CRT expert providing consultancy, advice and training Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements Implement and coordinate the development and maintenance of PHASTAR CRT tools Become familiar with and follow study documentation Strategic Leadership for the growth of the group in line with company objectives Ensure the principles in the PHASTAR checklist are followed rigorously Develop archiving systems and processes Ensure documentation for direct reports is audit ready at all times Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery Liaise with Study Statistician and Project Manager regarding resourcing and deliverables Responsible for study level resources and resolving resourcing issues with direct reports Attend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver internal and external training; identify non-technical training needs for direct reports . Identify areas where new processes are required and work with Operational Excellence team to implement new processes Qualifications : Core Competencies Good standard of written and verbal communication Facilitate project team meetings, ensure clinical trial teams are kept well informed of programming and projects at all times Deputise for the Head of Function at internal meetings Expert guidance to client Act as global programming lead Collaborate cross-functional teams to ensure expectations and objectives are aligned and being met Liaise with reporting teams and answer questions Excellent team work, with willingness to help others, ability to problem solve and seeing others point of view Enthusiastic and positive outlook Calm and professional under all circumstances Accept new challenges as learning opportunities Implement approaches that will result in error-free results Flexible and adaptable in outlook Open to feedback with a view of continual improvement Ability to adjust priorities where necessary Ability to make timely decisions relating to technical project issues Strong attention to detail Understanding of regulatory requirements Working in a proactive manner to identify and rectify study issues Working with complete autonomy Other Required Skills and Abilities Proactively identify own areas of development/improvement Sharing knowledge through attending and presenting at the programming forums and external conferences Helping to network for potential recruits as and when required Be involved in bid defence and other sales meetings helping to estimate resources required Bring industry changes to the attention of the company and be involved in updating processes Ability to drive efficiency to optimise outcome Train and mentor less experienced team members Line manage senior team members ensuring that each individual has the opportunity to reach their potential and identify their areas of development Coach and encourage internal and external teams about best practices which bring additional value Critical review of any publications Lead a team to create publications Representing the company at external events Experience and Education Requirements Educated to BSc or above within Computer Science, Mathematics or a Science related discipline SAS Programming Experience within the pharmaceutical industry Good awareness of clinical trial issues, design, and implementation. Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements APPLY NOW With the worlds eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Designation: Data Scientist (Clinical) We are seeking a highly skilled Data Scientist with strong expertise in clinical data standards and regulatory submission formats. The ideal candidate will have hands on experience working with OMOP and SDTM data models, capable of converting raw, heterogeneous clinical datasets into standardized formats required for regulatory submissions to agencies such as the FDA and PMDA. Key Responsibilities Convert and standardize clinical datasets originating in OMOP format into SDTM format according to CDISC regulatory submission guidelines. Design the ETL (Extract, Transform, Load) process for clinical datasets . Implement the ETL process using appropriate technical tools and languages . OHDSI recommendation on ETL implementation, experience with SQL builders, Python and R is advantageous. Organize and clean complex clinical trial data including labs, adverse events, vital signs, and other trial-related datasets into consistent, review-ready tables. Working exp on white rabbit -preferred Collaborate closely with clinical operations, statistical programming teams, and regulatory stakeholders to ensure data quality and compliance. Develop and maintain automated pipelines and workflows for efficient data transformation and validation. Provide expert input on clinical data standards and advise on best practices for data curation and submission readiness. Support regulatory submission processes by ensuring timely and accurate delivery of SDTM datasets. Act as a bridge between raw real-world data sources and regulatory requirements, translating technical challenges into actionable solutions Participate actively in all aspects of quality control to ensure the accuracy and integrity of data throughout the ETL and conversion process. Soft skills: fluent in English, problem-solving mentality, detail-oriented person, good communication and interpersonal skills, fast learner Additional (not must have): previous work/experiences on statistical programming, genomic data, NLP applications on healthcare datasets, data visualization If you or someone you know fits this role, apply directly through the job post or share your resume at navya_b@trigent.com

What you’ll do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What You’ll Bring Bachelor’s degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Master’s degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR – SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR – Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience. Perks & Benefits ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Considering applying At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above. To Complete Your Application Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At www.zs.com

What you’ll do - You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE . You will work on designing safety data mart for cross study analysis and exploratory analysis You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials. You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and executing technology projects. You will support leaders in engaging with clients to review clinical data models , determining requirements, establishing safety usecases, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will review and author high-level user stories and develop related tasks, acceptance criteria and review test cases Your will work closely with project teams in creating requirement Specifications, requirement traceability metrics, user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What You’ll Bring Bachelor’s degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Master’s degree in business analyst, Engineering or Science preferred. Experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of clinical data standards like CDISC (SDTM, ADaM), Safety data marts is required Experience of FHIR, HL7, USDM is preferred. Experience of Data mapping and transformation in clinical data using various tools like TAMR ,Oracle LSH etc Experience of generating SDTM, ADaM datasets as part of statistical programming deliverables of clinical trials. Experience of designing clinical data models as part of SDTM, ADaM or safety data marts for submission or exploratory analysis Experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration for exploratory analysis for clinical data of cross study Experience of working in any of Clinical trial design, data management, analytics, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR – SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR – Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is preferred. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred.