126 Cdisc Jobs

As a Project Manager in Clinical Data Management at SyMetric, your role involves handling customer projects independently with minimal supervision. Your responsibilities include: - Managing projects related to Clinical Data Management, including systems and services for IWRS/EDC/CTMS - Customer management for assigned projects - Monitoring project timelines and taking necessary actions to ensure projects stay on track - Ensuring all project deliverables are met for customer satisfaction - Serving as the primary point of contact from SyMetric Additionally, you will provide clinical data management support to the Clinical Operation Team, Sponsor, Customer, and Clinical Data Management Team. Your duties will involve reviewing various clinical data management documents, developing Data Management Plans and Electronic Case Report Forms, creating project specification documents, and coordinating User Acceptance Tests. Your technical skills should include proficiency in Microsoft Office Suite, Clinical Data Management System (CDMS) skills, and knowledge of Good Clinical Practice (GCP), Good Clinical Data Management Practice (GCDMP), CDISC, CDASH, and Regulatory Requirements. Experience with Clinical Database applications such as Electronic Data Capture (EDC) and Clinical Data Management System (CDMS) is beneficial. To excel in this role, you should have: - At least 4 years of experience in Clinical Data Management or health sciences-related projects - Experience working in an IT environment - Knowledge of Pharma Industry operations, with preference given to those who have worked with IWRS/EDC systems Your competencies should include strong intercultural awareness, excellent communication skills in English, effective time management, and the ability to work in virtual teams when necessary. Ideally, you should possess a postgraduate or bachelor's degree in any field, with specialization in Clinical Data Management methodologies. IT service management skills are an added advantage for this role.,

• Ensures that the Statistical Programming department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures(SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Statistical Programming department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Statistical Programming staff with diverse skills, abilities, and competencies meeting the business needs of the Statistical Programming department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and statistical programming in order to effectively serve as a Statistical Programming department mentor. Develops and provides training for Statistical Programming associates. • Prioritizes activities across Statistical Programming projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Statistical Programmers to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May be responsible for leading or supporting projects across multiple studies or programs. • May support business development activities. • May participate in or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required.

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. Location - Bangalore,Cochin,Kochi, Hyderabad,Karnataka,Kerala,Telangana

- 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 I About The Role : We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards. Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment. Key Responsibilities: Conduct statistical analyses as outlined in statistical analysis plans , including generating statistical graphics and verifying randomization codes. Prepare statistical sections of clinical study protocols , including sample size calculations . Annotate shell data displays and provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and supervise quality control (QC) of data displays and inferential statistics. Design, plan, and execute biostatistical components of clinical studies using sound statistical methodology. Develop statistical analysis plans (SAPs) and reporting specifications. Review and validate tables, listings, and figures (TFLs) , tabulation datasets, and derived datasets. Analyze and interpret results from clinical studies independently or under guidance. Maintain project documentation and contribute to cross-functional interactions. Utilize advanced computer skills for documentation and reporting using MS Word, Excel, PowerPoint , and project management tools. Primary Skills: Statistical AnalysisSample size estimation, inferential statistics, protocol development ProgrammingProficiency in SAS and clinical data analysis software Data StandardsFamiliarity with CDISC , SDTM , and ADaM DocumentationAnnotated CRFs, SAPs, shell displays, and QC records CommunicationEffective verbal and written communication in English Secondary Skills: Clinical Research: Understanding of clinical trial methodology and regulatory requirements Quality Assurance: QC of datasets and statistical outputs Collaboration: Cross-functional teamwork and stakeholder engagement Project Organization: File management and audit readiness Mentorship: Support and guidance for junior team members Preferred Qualifications: Masters degree in Statistics or related field Minimum 3 years of experience as a Statistician for Senior level; minimum 1 year or EDETEK training and supervisory approval for non-Senior level Proficiency in SAS and similar clinical data analysis tools Experience in preparing statistical components of protocols and SAPs Strong analytical and organizational skill Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

- 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.

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.

Shift: 2pm - 11pm IST (Remote) Role & responsibilities Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS. Program reports and listings as requested by project team members for ongoing studies. Develop transfer specifications with vendors for external data sources. Perform consistency checks on data transferred between client and external parties to ensure completeness and accuracy of data contained transfers. Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format Perform Quality Control (QC) on programming work performed by fellow Database Programmers. Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency MUST HAVE Skillsets: Bachelors degree OR certification. Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry. Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT Package/define.xml, SDRG development and SDTM data transfer operations on clinical studies. Understanding of regulatory requirements relevant to submissions. Knowledge of clinical trial study design and electronic data submission requirements.

Dear Candidate, Below are the Job Details for Clinical SAS Programmer role at CBCC Global Research LLP. Candidate should have the exposure of SDTM, ADAM and TLF. Job Location : Ahmedabad At Office Position : 2 Experience: 2-5 years in CRO preferred / Pharma industry Qualification : M. Sc. Statistics/Any Science Graduate Mandatory experience in Clinical trials Responsibilities: Ensure consistently high quality outputs for reporting and submission- 1.1. Build SAS datasets from clinical database. 1.2. Develop SAS macros, templates and utilities for data cleaning and reporting. 1.3. Utilize SDTM guidelines to build datasets. 1.4. Communicate with an internal team to create deliverables for pharmaceutical and biotechnology clients. 1.5. Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician. 1.6. Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy. 1.7. Write SAS programs to generate tables, listings, and figures and analysis datasets. 1.8. Review CRF annotations and data specifications. 1.9. Work in tandem with Biostatistics and Data Management member on various clinical projects. 1.10. Identify and edit checks per the data validation plan or data management plan. 1.11. Study management reports using SAS. 1.12. Validate the programmed analysis datasets, tables, listing and figures. 1.13. Perform analyses defined in the statistical analysis. 1.14. Prepare clinical and statistical summary reports. 1.15. Communicate with programming and statistics leads. 1.16. Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting. 1.17. Perform quality control on final reports. 1.18. Develop SAS coding and table templates for preparing, processing and analyzing clinical data. 1.19. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. 1.20. Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on project level activities. 1.21. As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, listings, summaries, figures and tables for the clinical project 1.22. Program, according to specifications, analysis datasets, listings, tables, and figures for clinical projects and/or apply standard statistical methods to standardized PK study designs 1.23. Track milestones for project deliverables. 1.24. Maintain records for all assigned deliverables including archiving of project analysis and associated documentation. 1.25. Comply with pre-defined project / study standards and specifications. 1.26. Validate the programmed analysis datasets, tables, listing and figures. Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting. 1.27. Develop SAS coding and table templates for preparing, processing and analysing clinical data. 1.28. Begins to develop a working knowledge of drug development and approval process 1.29. Other duties as assigned by reporting head or management Perks and Benefits Best in industry

In this vital role, you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate Real-World Evidence (RWE) from real-world healthcare data assets. The ideal candidate should possess a bachelor's degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and either SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential. Responsibilities: - Provide technical solutions to programming problems within CfOR - Lead and develop technical programming and process improvement initiatives within CfOR - Represent the programming function and participate in multidisciplinary project team meetings - Project manage programming activities, according to agreed resource and timeline plans - Ensure programming activities adhere to departmental standards and SOPs - Write and/or review and approve programming plans - Write and/or review and approve analysis dataset specifications - Review and approve key study-related documents produced by other functions, e.g., SAPs, CRF, Data Management Plan, etc. - Write, test, validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications, and other communications - Write, test, validate and execute department-, product- and protocol-level macros and utilities - Oversee the work of outsourced resources assigned to projects - Lead and/or participate in the development and review of CfOR policies, SOPs, and other controlled documents - Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings - Participate in the recruitment of programming staff - Actively participate in external professional organizations, conferences, and/or meetings - Provide input to and participate in intra-departmental and CfOR meetings - Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D) - Manage staff performance and oversee staff assignments and utilization - Relevant statistical programming, systems engineering, or application programming experience in a clinical development or life sciences setting What We Expect Of You: We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with the following qualifications. Basic Qualifications: - Doctorate degree OR - Masters degree and 4 to 6 years of relevant experience OR - Bachelor's degree and 6 to 8 years of relevant experience OR - Diploma and 10 to 12 years of relevant experience Preferred Qualifications: - Managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources in statistical programming projects - Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model Experience: - Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials - Team management - Global collaboration - Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery - Statistical programming: SQL required; SAS or R required; Python preferred - Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV) Key Competencies: - Hands-on programming and lead role - Expert statistical programming knowledge using SAS or R - Required: SAS or R - Required: SQL - Preferred: Python - Excellent verbal and written communication skills in English - Ability to have efficient exchanges with colleagues across geographical locations - Agile project management - Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare - OMOP common data model - Drug development life cycle - Statistics and basic epidemiology: Incidence and prevalence - Required for Regulatory RWE role: CDISC (SDTM, ADaM) - Scientific / technical excellence - Oral and written communication, documentation skills - Leadership - Innovation - Teamwork - Problem solving - Attention to detail What You Can Expect Of Us: As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination. Objects in your future are closer than they appear. Join us at careers.amgen.com.,

As a Statistical Programmer II at Advanced Clinical, you will play a crucial role in providing programming support for clinical trials. Your responsibilities will include exceeding the expectations and responsibilities of a Statistical Programmer I, understanding and implementing CDISC and other regulatory standards, and following internal SAS programming conventions. You may also serve as a programming lead, prepare programming specifications for SDTM, ADaM, and other derived datasets, and work with cross-functional team members to ensure accurate and high-quality statistical outputs. In this role, you will apply your knowledge of SAS programming to program and develop statistical outputs according to the statistical analysis plan and other specifications. This includes working on SDTM, ADaM, or other derived datasets, tables, listings, figures, and reviewing case report form design. Additionally, you will need to follow Standard Operating Procedures (SOPs) and have a strong understanding of departmental and company procedures to guide others effectively. The ideal candidate for this position should have a degree in Statistics, Computer Science, or a closely related field. However, work experience may be substituted for the degree. You should have a minimum of 2 years of direct SAS programming experience in pharmaceutical development or CRO environment, along with good knowledge of medical terminology and the conduct and analysis of clinical trials. Knowledge of relevant industry data standards such as CDISC SDTM, ADaM, etc., is also required. Excellent oral and written communication skills, organizational skills, and attention to detail are essential for this role. At Advanced Clinical, we are committed to diversity and inclusion throughout our organization. We believe that a diverse staff enables us to draw on different perspectives, enhance our efficiency and effectiveness, and strengthen our legitimacy and relevance in delivering services to our clients. We value individuals from various backgrounds and cultures and prioritize an inclusive workplace that welcomes diverse ideas and appreciates valuable experiences. Advanced Clinical is an equal opportunity employer, and our commitment to diversity and inclusion applies to all aspects of employment. We provide accommodations for individuals with disabilities or handicaps to ensure a supportive and inclusive work environment. If you require any accommodations, please inform your Recruiter to discuss available alternatives.,

We’re hiring Statistical Programmers for Mumbai, Pune & Bangalore | Salary: 11–20 LPA | General Shift | Min. 2+ yrs SAS programming + International BPO exp. required Graduation is mandatory Required Candidate profile | Lead global clinical programming & regulatory projects

You will be responsible for creating and maintaining CDISC compliant datasets (SDTM, ADaM) and generating Tables, Listings, and Figures (TLFs) for clinical study reports. Your role will involve performing efficacy analyses using R programming, developing standard macros for data manipulation, and participating in study handling activities if you are at a senior level. You will utilize the CRT package for data analysis and contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses. Working within a Functional Service Provider (FSP) environment, you will troubleshoot programming issues, ensure compliance with regulatory guidelines and company SOPs, and collaborate with biostatisticians and clinical data managers to support clinical trial activities. Additionally, you will be responsible for developing and maintaining programming documentation. Requirements: - 6 to 14 years of relevant experience in statistical programming. - Strong knowledge of CDISC standards (SDTM, ADaM). - Extensive experience in generating TLFs. - Proficiency in R programming (minimum 6 months experience). - Experience in efficacy analysis. - Experience with CRT package preferred. - Experience with ISS and ISE preferred. - Experience working in an FSP environment. - Knowledge of utilizing and debugging standard macros. - Study handling experience preferred for senior levels. Qualifications: - Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related field. - Proven experience in statistical programming for clinical trials. - Strong understanding of clinical data management principles. - Excellent problem-solving and analytical skills. - Ability to work independently and as part of a remote team.,

Position: Data Engineer, Sr - I *** JOB DESCRIPTION *** OVERVIEW The Data Engineer, Sr - I will work closely with clients and provide high level technical consulting services, configuration of the elluminate platform, development and oversight for specific projects that include trial configuration, quality control, project management, assessing new technologies, process improvements, system validation, SOP development, custom analytics development, clinical software implementations and integrations, platform configuration, ETL and custom analytics development. As a Data Engineer, Sr - I, you will serve as the primary technical lead, spearheading consulting efforts related to clinical systems software. You will also design and develop reporting programs as needed. KEY TASKS & RESPONSIBILITIES Leading consulting efforts and providing high-level technical consulting services to clients, including configuring the elluminate platform and overseeing specific projects such as trial configuration, quality control, and project management. Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate Mapper, and Qlik. Providing technical guidance, training, and support to team members and users on processes, technology, and products. Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. Possessing high-level debugging skills for ETL or analytical issues by referring to the required source data. Demonstrating in-depth knowledge of at least one Elluminate module, with hands-on experience in all other modules. Delivering proactive technical support for all client-reported support tickets. Facilitating client onboarding workshops and conducting training sessions for end users on the Elluminate platform. Configuring, migrating, and supporting the elluminate platform for assigned clients. Creating and maintaining all required specifications and quality control documents as per SOP and processes. Ensuring compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures. Position: Data Engineer, Sr - I CANDIDATES PROFILE Education/Language: 5+ years of professional experience in a Services or Consulting role preferred Bachelor's or Master's degree in science, technical or business discipline or equivalent experience preferred 5+ years in database design and development experience preferred Understanding of Cloud / Hybrid data architecture concepts is a plus Prior experience in customer facing roles is a plus Knowledge of clinical trial data is a plus - CDISC ODM, SDTM, or ADAM standards Experience in Pharmaceutical/Biotechnology/Life Science industry is a plus Experience in Data Capturing tools (Rave, Veeva, InForm, IVRS) Professional Skills & Experience: Have critical observation and communication skills to Identify any gaps in processes or product Ability to work with various technical and non-technical teams both internal to eCS and clients Must be team oriented with strong collaboration, prioritization, and adaptability skills Excellent knowledge of English; verbal and written communication skills with ability to interact with users and clients providing solutions Experience in the Life Sciences industry, CRO / Clinical Trial regulated environment preferred Experience in regulatory computer systems validation a strong plus Demonstrating strong analytical and problem-solving skills to identify issues and develop creative solutions that drive results. Conveying information clearly and concisely to diverse audiences, facilitating understanding and collaboration. Working effectively in a team environment, contributing to group objectives, and supporting colleagues. Adapting to changing circumstances and accepting new challenges with a positive attitude. Understanding clinical trial data and applying CDISC, SDTM/AdAM standards. Performing other duties as assigned. Position: Data Engineer, Sr - I Technical Skills & Experience: Proficient in SQL, T-SQL, PL/SQL programming or R Package or Python or SAS Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Experience with multiple Database Platforms: Oracle, SQL Server, Teradata, DB2 Oracle Experience with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related Familiarity with other languages and concepts: .NET, C#, Python, R, Java, HTML, SSRS, AWS, Azure, Spark, REST APIs, Big Data, ETL, Data Pipelines, Data Modelling, Data Analytics, BI, Data Warehouse, Data Lake or related

Role & responsibilities Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Preferred candidate profile 5+ years work experience in ADAM and R programming Experience with R Packages, R programming - Data Manipulation R Shiny dashboard is a plus R Markdown is a plus R Validation and Debugging options experience

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory requirements. Key Responsibilities Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards and regulatory guidelines (FDA, PMDA, EMA). Program and validate tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions. Ensure programming deliverables meet quality, timeline, and compliance standards. Collaborate with statisticians and clinical teams to translate analysis specifications into efficient programming solutions. Perform data quality checks and resolve issues in coordination with data management. Contribute to standardization efforts including macros, libraries, SOPs, and best practices. Support ad-hoc requests , exploratory analyses, and regulatory audits. Required Skills & Qualifications Bachelor’s/Master’s degree in Biostatistics, Computer Science, Life Sciences , or related field. Strong programming skills in SAS (Base SAS, SAS/STAT, SAS/Macro) , Python , and R . Hands-on experience with SDTM and ADaM dataset creation and validation . Solid understanding of CDISC standards and regulatory submission requirements. Knowledge of clinical trial processes , ICH-GCP guidelines , and statistical concepts. Strong problem-solving , attention to detail, and documentation skills. Experience with Cloud environments like AWS and Azure . Good to Have (Optional) Experience with Define.xml , Pinnacle 21 , and e-submission tools . Exposure to Life Sciences , Pharma/Clinical Research , or CRO settings . Familiarity with safety and efficacy analysis in clinical trials. How to Apply Interested candidates can apply directly through Naukri or send their updated resume to shyamala.gunde@excelra.com

Openings for Statistical Programmer - Band - 4/5/6 Salary Up-to - 30 LPA + VAriables Any Grad / PG with - 5 yrs of exp Clinical SAS , Creation & Validation of ISS & ISE reports Development of sas macros etc Call @ WhatsApp- Shubhani -8595849767

Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate inventory management of biological samples, investigational products, and documents to have proper track. Managing the CSR schedules and dispatch call. Managing and coordinating the clinical data entry team with the CDS team for CDISC datasets. Contributing to overall project objectives. Interpersonal relationship with the study team. Communicating the projects goals throughout the organization. BCSO calls for BA/BE centre capacity utilization. Coordinating IEC and IP/Plasma sample storage calls. Preferred candidate profile The candidate should have minimum 7+ years of experience in BA/BE Project management. Good in written and verbal communication. Good in presentation skills

- Experience Required: 5+ years into clinical SAS Programming Requirements: - Strong experience in Base SAS, Advance SAS - Must have good experience in ADaMs, table, listing and figure creation. - Good to have study lead exposure.

Minimum experience: 8 years. We're seeking someone who brings: Extensive hands-on experience in End to End programming A strategic mindset and the ability to lead complex projects Strong collaboration skills with cross-functional clinical teams A passion for science-driven programming that impacts patient outcomes If you're ready to take on a high-impact role with a global sponsor we’d love to connect!

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical development. Experience: 7-10 years Education: M.Tech / M.Sc / Ph.D. in Life Sciences, Biotechnology, Pharmacology, Clinical Research, or related disciplines Preferred Background: Life Sciences Consulting | Clinical R&D | Clinical Operations Strategy Key Responsibilities: - Lead and manage client engagements focused on clinical operations transformation, process improvement, and technology enablement. - Design operating models, workflows, and KPIs for clinical development functions. - Collaborate with cross-functional teams (regulatory, safety, data management) to align clinical strategies with enterprise goals. - Prepare business cases, PoVs, and transformation roadmaps for clients. - Support proposal development and go-to-market (GTM) strategies in the clinical domain. - Mentor junior consultants and contribute to knowledge building within the practice. Must-Have Skills: - Strong understanding of the clinical development lifecycle (from trial design through close-out). - Demonstrated experience in managing/leading consulting engagements. - Exposure to CRO management, site selection, clinical monitoring, or clinical project management. - Excellent communication, stakeholder management, and analytical skills. Nice-to-Have Skills: - Familiarity with technologies like SDTM, CDISC, CTMS, eTMF, or EDC systems. - Prior experience with clinical digital transformation initiatives (e.g., decentralized trials, risk-based monitoring). - Certifications in clinical project management or data standards (e.g., CCDM). EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people, and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. ZS Life Science R&D Technologist in Clinical development ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. 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. Travel: Travel is a requirement at ZS for client facing ZSers business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain 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:

Biostatistician I Job Description: We are seeking a skilled and detail-oriented Statistician to support statistical analyses for clinical research studies. This role involves designing and executing statistical components of protocols, generating randomization codes, and preparing annotated shell data displays. The Statistician will contribute to the development of statistical analysis plans and ensure the accuracy and compliance of data displays with regulatory standards. Statisticians report to the Biostatistics Manager and collaborate closely with cross-functional teams in a clinical research environment. Key Responsibilities: Conduct statistical analyses as outlined in statistical analysis plans , including generating statistical graphics and verifying randomization codes. Prepare statistical sections of clinical study protocols , including sample size calculations . Annotate shell data displays and provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and supervise quality control (QC) of data displays and inferential statistics. Design, plan, and execute biostatistical components of clinical studies using sound statistical methodology. Develop statistical analysis plans (SAPs) and reporting specifications. Review and validate tables, listings, and figures (TFLs) , tabulation datasets, and derived datasets. Analyze and interpret results from clinical studies independently or under guidance. Maintain project documentation and contribute to cross-functional interactions. Utilize advanced computer skills for documentation and reporting using MS Word, Excel, PowerPoint , and project management tools. Primary Skills: Statistical Analysis: Sample size estimation, inferential statistics, protocol development Programming: Proficiency in SAS and clinical data analysis software Data Standards: Familiarity with CDISC , SDTM , and ADaM Documentation: Annotated CRFs, SAPs, shell displays, and QC records Communication: Effective verbal and written communication in English Secondary Skills: Clinical Research: Understanding of clinical trial methodology and regulatory requirements Quality Assurance: QC of datasets and statistical outputs Collaboration: Cross-functional teamwork and stakeholder engagement Project Organization: File management and audit readiness Mentorship: Support and guidance for junior team members Preferred Qualifications: Master's degree in Statistics or related field Minimum 3 years of experience as a Statistician for Senior level minimum 1 year or EDETEK training and supervisory approval for non-Senior level Proficiency in SAS and similar clinical data analysis tools Experience in preparing statistical components of protocols and SAPs Strong analytical and organizational skill Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Job Description Job Description: We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations and annotated shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project documentation including protocols, annotated CRFs, SAPs, and programming/QC records. Organize and manage electronic project directories to ensure accessibility and version control. Mentor junior programmers and provide training on SAS programming and clinical data standards. Primary Skills: Statistical Programming: Proficiency in SAS for clinical data analysis Clinical Research: Understanding of clinical trial design , randomization, and statistical methodology Data Standards: Familiarity with CDISC , SDTM , and ADaM Quality Assurance: Experience in QC processes and dataset validation Documentation: Ability to create and maintain technical and regulatory documentation Secondary Skills: Statistical Analysis: Sample size estimation, inferential statistics, protocol development Data Management: Annotated CRFs, dataset specifications, metadata handling Communication: Clear documentation and collaboration with cross-functional teams Mentorship: Training and guiding junior staff in programming and standards Project Organization: File management, version control, and audit readiness Preferred Qualifications: Master's degree in Statistics or related field (or Bachelor's with equivalent experience) Minimum 3 years of experience as a Biostatistician in the clinical research industry Proficiency in SAS and clinical data analysis software Experience with CDISC standards and regulatory compliance Prior experience in mentoring or training junior team members Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Purpose The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management). Key Responsibilities Supporting with CDISC implementation of studies with Real world data QC of SDTM/ADaM datasets as required Review the aCRF, Specs, relevant documentation like SDRG/ADRG, Define.xml as relevant Expertise working across different disease areas like Oncology, Vaccines, Respiratory etc Guide Real World Programmers on NIS with CDISC expectations Technical: Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs Author, review and approve study TFL shells and dataset specifications Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice Identify data issues and outliers Complete, review and approve CDISC Validation tool reports Identify data and standards issues and resolve or escalate as appropriate Awareness of emerging standards and associated impact to ongoing and future planned trials Maintain proficiency in SAS and awareness of developments Maintain study master file documents and any other documents that are required to be audit ready People Management: Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports Provide coaching and mentoring of staff to achieve excellence. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs Interview and effectively on-board and integrate new staff members Provide programming technical leadership and coaching Project Management: Oversight of key client projects/portfolios. To include: Being Veramed Project Manager on client accounts and projects Maintain the project plan Proactive management of resource, scope change and risks Manage the delivery of projects to budget Manage client expectations and issue resolution General: Lead internal and client study, project and cross functional team meetings effectively Present study updates internally and at client meetings Share scientific, technical and practical knowledge within the team and with colleagues Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training Build effective collaborative working relationships with internal and client team members Ensure learnings are shared across projects or studies Develop and provide internal technical training where appropriate Lead process improvement initiatives Minimum Qualification Requirements BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience) At least 8 years of relevant industry experience Other Information/Additional Requirements Understanding of clinical drug development process, relevant disease areas, endpoints and study designs Awareness of industry and project standards & ICH guidelines Excellent verbal and written communication skills Interpersonal/teamwork skills for effective interactions Proficiency in data handling using SAS or other statistical software (e.g. R) Self-management skills with a focus on results for timely and accurate completion of competing deliverables Demonstrated problem solving ability and attention to detail Ability to work independently and as part of a team Ability to manage a portfolio of projects and/or people