Senior Standards Developer I

2 weeks ago


bangalore, India AstraZeneca Full time

Introduction to role:

Join our Biopharmaceuticals R&D team as a Senior Standards Developer I, where you will be responsible for delivering moderate complexity AZ end-to-end Clinical Analysis and Reporting Standards in your area of expertise. This role requires technical skills and adequate industry knowledge to independently perform tasks while using judgement about seeking guidance in complex situations. You will be primarily responsible for the development and creation of study metadata for SDTM and ADaM in a specific system.


Accountabilities :

As a Senior Standards Developer I, you will develop and maintain one or more median/high complexity analysis and reporting standards. You will monitor and update requests within a defined system, perform independent quality control, and lead the quality of your own deliverables. You will also contribute to the development of best practices to develop, maintain and publish data standards consistently. Collaboration with clinical standards governance groups is key, as is contributing as a subject matter expert support to drug projects on AZ Clinical Standards. You will also assist with metric reporting on standards and requests, and contribute to the function by training and mentoring.


Essential Skills/Experience:

- BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.

- Accomplished in specialised standards development skills or accomplished experience in Biometrics functions.

- Knowledge of MS Excel, deep attention to the details and a systematic approach to work.

- Good knowledge of the clinical development process.

- Good Project management skills.

- Good knowledge of industry standards (eg, CDASH, SDTM, ADaM).

- Good knowledge of the structure and application of clinical dictionaries including MedDRA, WHODrug Global, and Labcodes.

- Good knowledge of medical terminology and pharmacology as it relates to pharmaceutical drug development and associated regulations.

- Good communication skills in both written and spoken English.

- A clear demonstration of behaviours of truth seeking rather than success seeking.

- Embracing peer review.


Desirable

- Ability to apply clinical data standards technical knowledge to problem solving.

- Ability to proactively manage concurrent activities within role.

- Understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl).

- Clinical Laboratory experience.



  • bangalore, India AstraZeneca Full time

    Introduction to role:Join our Biopharmaceuticals R&D team as a Senior Standards Developer I, where you will be responsible for delivering moderate complexity AZ end-to-end Clinical Analysis and Reporting Standards in your area of expertise. This role requires technical skills and adequate industry knowledge to independently perform tasks while using...

  • Senior Engineer

    2 weeks ago


    bangalore, India Celeros Flow Technology Full time

      1.0 Job Summary Responsible for undertaking controls & instrumentation (C&I) engineering activities across OE, A/Market and Development. Providing Technical support on tender enquiries.   As a Senior C&I engineer, your primary duty is to undertake a defined range of engineering activities in line with all relevant processes and quality requirements. You...


  • bangalore, India Philips Full time

    Job Title Senior Software Technologist I Job Description Job title: Senior Software Technologist IYour role: Creates high quality working software Features driven development in an agile approach Actively participates in sprint planning, daily stand-up meetings, sprint reviews, sprint retrospectives and backlog refinement. Contributes to continuous...


  • bangalore, India Infogain Full time

    Middleware Developer (Standard) with skills Middleware Development, Kronos Development, Middleware Development for location Any Infogain Base Location (Noida, Gurugram, Bangalore, Mumbai, Pune) Posted on: May 16, Share on Linkedin Share on Twitter Share on Facebook ROLES & RESPONSIBILITIES Essential Duties and Responsibilities • Apply...


  • bangalore, India Philips Full time

    Job Title Senior Software Technologist I/II - Embedded Job Description BE/Btech/ME/MTech with 10-15 Years of exp in Embedded Systems As a Senior Engineer with expertise in Embedded Systems, you will play a crucial role in designing, developing, and maintaining Device software. This role is focused on hands-on work, but it also requires the ability to direct...


  • Bangalore, India Philips Full time

    Job TitleSenior Software Technologist I - C#Job DescriptionSenior Software Technologies IYour role:Hands-on experience in software design and development with at least 8 years in C#/.NET with windows and Multi-ThreadingHas experience designing and developing Oracle database applications(writing Stored Procedures, Functions and Triggers), They also have...


  • bangalore, India Expedia Group Full time

    Software Development Engineer IDo you have a hunger to make a difference with one of the most loved consumer brands in the world, and Power Travel for Everyone Everywhere? If so, this is the job for you! What You'll Do: You will utilize appropriate methods and approaches to develop practical solutions for the business You will communicate complex...


  • bangalore, India Kaplan Full time

    Senior Salesforce Engineer - IFor more than 80 years, Kaplan has been a trailblazer in education and professional advancement. We are a global company at the intersection of education and technology, focused on collaboration, innovation, and creativity to deliver a best in class educational experience and make Kaplan a great place to work.Our offices in...

  • Security specialist

    4 weeks ago


    Bangalore, India Philips Full time

    Job TitleSecurity specialist - Regulatory & StandardsJob DescriptionJob title:Security specialist - Regulatory & StandardsYour role:As the Product Security process expert you will responsible for maintaining and enhancing the global Philips Product Security policy and process framework, driving the future strategic directions on product security...


  • bangalore, India Kaplan Full time

    Senior Salesforce Engineer - I For more than 80 years, Kaplan has been a trailblazer in education and professional advancement. We are a global company at the intersection of education and technology, focused on collaboration, innovation, and creativity to deliver a best in class educational experience and make Kaplan a great place to work. Our offices in...

  • Senior C&I Engineer

    2 weeks ago


    bangalore, India SNC-Lavalin Full time

    Job Description We are currently seeking a Senior/Principal C&I Engineer to join the Decommissioning & Waste Services market within our Nuclear & Power business. Ideally based in Northwest England although other locations UK wide can be considered.  You will work in our market which is predominantly focused on delivering engineering and waste...

  • Web Developer I

    2 weeks ago


    bangalore, India Mouser Electronics Full time

    JOB DESCRIPTION Job Title: Web Developer I Location: India Web Developer I is responsible for multiple web and back office applications written on .NET development platforms. Analyzes, designs, codes, debugs, assists in testing and documents software. Participates in all phases of the software development life cycle and is responsible for new and...


  • bangalore, India Philips Full time

    Job Title Senior Software Technologist I - Full Stack Job Description Job title: Senior Software Technologist IYour role: Participate in the development of application softwareOwn the detailed design of the system.Comfortable in design, implementation, testing, and documentationEnsure quality by writing developer level tests (unit, component etc)Works with...


  • bangalore, India Kaplan Full time

    Senior Salesforce Engineer - I For more than 80 years, Kaplan has been a trailblazer in education and professional advancement. We are a global company at the intersection of education and technology, focused on collaboration, innovation, and creativity to deliver a best in class educational experience and make Kaplan a great place to work.Our offices in...


  • Bangalore, Karnataka, India Kaplan Full time

    Senior Salesforce Engineer - I For more than 80 years, Kaplan has been a trailblazer in education and professional advancement. We are a global company at the intersection of education and technology, focused on collaboration, innovation, and creativity to deliver a best in class educational experience and make Kaplan a great place to work.Our offices in...


  • Bangalore, India Kaplan Full time

    Senior Salesforce Engineer - I For more than 80 years, Kaplan has been a trailblazer in education and professional advancement. We are a global company at the intersection of education and technology, focused on collaboration, innovation, and creativity to deliver a best in class educational experience and make Kaplan a great place to work.Our offices in...


  • bangalore, India IEEE Full time

    Program Manager Standards (E4046B)-240026:IN70 Description Job Summary A deep and applicable knowledge of the technical, economic, and political landscape and trends in India that includes the roles of government, industry, and NGOs, and the opportunities they present for IEEE in standards development and standards-related activities. Need to...

  • PHP Developer

    2 days ago


    bangalore, India Infogain Full time

    PHP Developer (Standard) with skills PHP, LAMP, REST APIs, MySQL, Google Apigee for location Any Infogain Base Location (Noida, Gurugram, Bangalore, Mumbai, Pune) Posted on: May 16, Share on Linkedin Share on Twitter Share on Facebook ROLES & RESPONSIBILITIES Core Skills 1. Collaborate with project stakeholders to gather...


  • bangalore, India Philips Full time

    Job Title Software Technologist I/II - Embedded Job Description BE/BTech/MCA/MTech with 4-9 Years of exp in Embedded Systems As a Senior Engineer with expertise in Embedded Systems, you will play a crucial role in designing, developing, and maintaining Device software. This role is focused on hands-on work, but it also requires the ability to direct others...

  • Product Designer

    2 weeks ago


    bangalore, India I BUILT IT Full time

    Requirement: The opportunity is open solely for applicants with prior experience as a 3 D Modeler, Product Designer, architect, or 3D artist.Note: To get shortlisted, please share your portfolio at Three evaluation rounds will be conducted to assess your skill level.Job descriptionWe are seeking a product designer to join our rapidly expanding team,...