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7.0 - 12.0 years
14 - 19 Lacs
Bengaluru
Work from Office
As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). you'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally. Accountabilities: Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP. Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications. Supervise/manage external vendors and contract programmers. Be responsible for progress of programming activities. Review, maintain, and approve protocol-specific documents as vital. Provide guidance and mentoring to peer and junior-level Programmers. Act as the primary department contact to ensure implementation of department standards in all studies. Contribute ideas towards the optimization of standard operating procedures. Lead team meetings when appropriate. Engage in any other activities as required. Essential Skills/Experience: bachelors Degree (Minimum) or masters Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members Expertise in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.
Posted 1 week ago
4.0 - 9.0 years
15 - 20 Lacs
Chennai
Work from Office
Hi, Wishes. Pleasure connecting with you. Job Summary: We are hiring mid-level Statistical Programmers (4 - 8 years of experience) with strong hands-on expertise in SAS programming for clinical trials. The role requires experience in SDTM and ADaM dataset creation, TLF programming, and knowledge of CDISC standards. You will be working on end-to-end programming activities for Phase IIV clinical studies. Mode of Work : WFO Exp Range : 4 to 8 yrs Work Location : CHENNAI CTC Range : Best in the industry ***** Looking for SHORT JOINERs ***** Key Responsibilities: SDTM Programming: Create and validate SDTM datasets as per CDISC guidelines. Perform CRF annotation and author/review specifications . Generate Define.xml and ensure compliance using Pinnacle 21 . Work on Study Data Reviewers Guide (SDRG) and submission packages. ADaM Programming: Develop ADaM datasets for Safety and Efficacy analysis. Write and validate ADaM specifications and ensure alignment with SAP. Prepare ADaM Define.xml and reviewer documentation. TLF Programming: Generate and QC Tables, Listings, and Figures (TLFs) as per SAP. Use SAS Graph and macros to build clinical outputs. General Programming & Project Work: Independently write or modify SAS programs from scratch or using templates. Develop or enhance custom macros to streamline programming tasks. Work in both production and validation programming roles. Handle multiple studies simultaneously , ensuring high-quality deliverables. Participate in integration and pooling (ISS/ISE) of datasets. Work on CRT packages and electronic submission readiness. Required Skills: Strong knowledge of SAS Base, SAS/STAT, SAS/GRAPH in a clinical trial setting. Solid understanding of CDISC SDTM and ADaM standards . Experience with Define.xml creation and validation tools like Pinnacle 21 . Hands-on exposure to multiple therapeutic areas and clinical phases . Experience in ISS/ISE and integrated datasets is a strong plus. Nice to Have: Familiarity with tools such as Define.xml Generator, SAS Clinical Standards Toolkit . Knowledge or EXP in R Programming is OPTIONAL Exposure to MACRO programming and reusable code frameworks . Understanding of regulatory requirements for FDA/EMA submissions . What We Offer: Projects with top global pharma clients. Work with a high-performing and collaborative clinical data team. Competitive compensation, learning, and growth opportunities. If Interested, click APPLY ONLINE for IMMEDIATE response. Best, ANANTH | GSN HR | 9840035825 | Google review : https://g.co/kgs/UAsF9W
Posted 3 weeks ago
7 - 12 years
20 - 30 Lacs
Hyderabad
Remote
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.
Posted 1 month ago
1 - 4 years
6 - 10 Lacs
Bengaluru
Work from Office
Provide experienced technical expertise to develop process methodology for department to meet internal and external clients needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Essential Functions Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. Program and plan the integration of databases from multiple studies or sources. Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies. Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications. Fulfill project responsibilities at the level of statstical team lead for single complex studies or group of studies. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for single studies. May manage project budget and resource requirements, and provide revenue forecasts for single studies. Provide training and guidance to lower level staff. Qualifications Masters Degree Computer science or related field and 7 years relevant experience Req Or Bachelors Degree Computer science or related field and 8 years relevant experience Req Equivalent combination of education, training and experience in lieu of degree Req Knowledge of statistics, programming and/or clinical drug development process Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language Good organizational, interpersonal, leadership and communication skills Ability to effectively manage multiple tasks and projects Excellent accuracy and attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com
Posted 2 months ago
4 - 7 years
5 - 9 Lacs
Uttar Pradesh
Work from Office
1>Installation and configuration of various SAS platforms on windows/Linux server 2>Troubleshooting the configuration issues that arise as part of installation and configuration of the SAS server 3>Performing the health check of the sas servers on timely manner and ensuring the system readiness for the business users. 4>Troubleshooting the user login issues to the SAS client applications and SAS Web Applications 5>Performing the SSL certificate Renewal when required. 6>Performing the SAS License Renewal 7>performing the SAS content migration between TEST/DEV/PROD environments. 8>Monitoring the space on the respective SAS Servers for the smooth execution of the batch jobs 9>Involved in the patching activity and performing the PVT(Post Verification Test) to ensure that the SAS environment is ready for the batch executions. 10>Building the ODBC connection setup for different data stores(Oracle,Redshift,DB2 etc) 11>Troubleshooting the CLI errors related to libname statements(Involves SQLPassThru and direct libname statements of respective databases). 12>Performing the HOT FIX installation when required ,as an resolution for the SAS issue 13>Troubleshooting the LAN mounting issues of the users and ensuring the content, present in the CIFS(Common Internet FileSystem) is brought to the SAS for further processing. 14>Troubleshooting the Proc Export/Import issues raised by the users. 15>Creating the thirdparty libraries using SAS Management Console when required. 16>Creation of multiple SAS Applications server for performance reasons if required.
Posted 2 months ago
3 - 5 years
4 - 8 Lacs
Bengaluru
Work from Office
Job Title SAS Developer Responsibilities Minimum 3-5 years of work experience in SAS EG and SAS CI Hands on experience in data transferring from different sources to SAS database Expertise in Data Step and Proc Step including merge statement , proc sql and macros , SAS functions Experience in automation and SAS reporting Good communication skill is must. Candidate should independently work deliver the project work as well as deal with client . Location Any Infosys DC in India Preferred Skills: Technology->Reporting Analytics & Visualization->SAS Enterprise Guide Educational Requirements Bachelor of Engineering Service Line Data & Analytics Unit * Location of posting is subject to business requirements
Posted 2 months ago
4 - 7 years
6 - 9 Lacs
Uttar Pradesh
Work from Office
1>Installation and configuration of various SAS platforms on windows/Linux server 2>Troubleshooting the configuration issues that arise as part of installation and configuration of the SAS server 3>Performing the health check of the sas servers on timely manner and ensuring the system readiness for the business users. 4>Troubleshooting the user login issues to the SAS client applications and SAS Web Applications 5>Performing the SSL certificate Renewal when required. 6>Performing the SAS License Renewal 7>performing the SAS content migration between TEST/DEV/PROD environments. 8>Monitoring the space on the respective SAS Servers for the smooth execution of the batch jobs 9>Involved in the patching activity and performing the PVT(Post Verification Test) to ensure that the SAS environment is ready for the batch executions. 10>Building the ODBC connection setup for different data stores(Oracle,Redshift,DB2 etc) 11>Troubleshooting the CLI errors related to libname statements(Involves SQLPassThru and direct libname statements of respective databases). 12>Performing the HOT FIX installation when required ,as an resolution for the SAS issue 13>Troubleshooting the LAN mounting issues of the users and ensuring the content, present in the CIFS(Common Internet FileSystem) is brought to the SAS for further processing. 14>Troubleshooting the Proc Export/Import issues raised by the users. 15>Creating the thirdparty libraries using SAS Management Console when required. 16>Creation of multiple SAS Applications server for performance reasons if required.
Posted 3 months ago
6 - 9 years
8 - 11 Lacs
Bengaluru
Work from Office
Your Profile As a SAS Developer with Capgemini, you will have 6+ years of experience in SAS technology with strong project track record. In this role you will paly a key role in: Shall have strong experience in SAS viya, Python Debugging and Logging. Using open source code in SAS Viya decision. Shall work in Agile Devops Setup. Your Profile Good to have experience with DS2, fluxCD, elastic. Should have experience in credit riskand Modelling with 8+ years of hands on experience. What youll love about working here Choosing Capgemini means having the opportunity to make a difference, whetherfor the worlds leading businesses or for society. It means when the futuredoesnt look as bright as youd like, youhave the opportunity tomake change:torewrite it. When you join Capgemini, you dont just start a new job. You become part of something bigger. A diverse collective of free-thinkers, entrepreneurs and experts, all working together to unleash human energy through technology, for an inclusive and sustainable future. You can exponentially grow your career by being part of innovative projects and taking advantage of our extensive Learning & Development programs. With us, you will experience an inclusive , safe, healthy, and flexible work environment to bring out the bestin you! You also get a chance to make positive social change and build a better world by taking an active role in our Corporate Social Responsibility and Sustainability initiatives. And whilst you make a difference, you will also have a lot of fun . About Capgemini:
Posted 3 months ago
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