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Programming • India

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Database Programming Manager

Database Programming Manager

Astellas PharmaBengaluru / Bangalore, India
Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabili...Show moreLast updated: 11 days ago
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Manager, Statistical Programming

Manager, Statistical Programming

ParexelHyderabad / Secunderabad, Telangana, India
Manage and oversee team activities including appropriate resourcing of staff, staff assignments, and quality control of project deliverables and timely delivery of project deliverables.Meet and aim...Show moreLast updated: 11 days ago
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SDTM programming-Sql

SDTM programming-Sql

Netpace IncBengaluru / Bangalore, India
Total Years of Experience - 4+.Relevant Years of Experience - 4+.Notice-Immediate to 10 Days MAX.SDTM programming-Sql, clinicatl trial payemnt knowwldge, handson SVT logic.Individual contributor wi...Show moreLast updated: 11 days ago
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C programming

C programming

InfosysBengaluru / Bangalore, India
C programming, Embedded OS, Linux or VxWorks; Cisco IOS.A day in the life of an Infoscion.As part of the Infosys delivery team, your primary role would be to interface with the client for quality a...Show moreLast updated: 11 days ago
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Video Programming Specialist

Video Programming Specialist

Ziff DavisPune, India
This role is a key operational cog in our team, responsible for hands-on publishing, platform optimization, and calendar management across our owned-and-operated sites (CNET.The ideal candidate is ...Show moreLast updated: 2 hours ago
Senior Programming Lead

Senior Programming Lead

ScaleneWorksBengaluru, Karnataka, India
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Involves in the development, validation, and review of study & standard programs / macros (Including SAS, CQL, PL / SQL, SPOTFIRE, R-Programming, Python) that support standard and study-level conve...Show moreLast updated: 30+ days ago
Embedded Systems Programming

Embedded Systems Programming

Epergne SolutionsPune, Maharashtra, India
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Embedded C & C++ development.Required Skills & Experience : .Embedded C & C++ Development.Must have experience working with. Familiarity with debugging code in RTOS-based environments.Must...Show moreLast updated: 30+ days ago
Python (Programming Language)

Python (Programming Language)

Trigent Software Private Limitedbengaluru, KA, India
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PDC2C Summary : As an Application Support Engineer, you will act as software detectives, providing a dynamic service that identifies and solves issues within multiple components of critical business...Show moreLast updated: 5 days ago
Perl Programming

Perl Programming

Talent WorxMumbai, MH, IN
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Talworx is hiring for Perl Programming role.Must Have skills - Perl programming, Shell Scripting, PL / SQL.Discoverer, APEX, SFTP process, API integrations. Hands-on experience in Perl development wit...Show moreLast updated: 30+ days ago
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Biostatistical Programming Manager

Biostatistical Programming Manager

AmgenHyderabad / Secunderabad, Telangana, India
HOW MIGHT YOU DEFY IMAGINATION.If you feel like you're part of something bigger, it's because you are.At Amgen, our shared mission—to serve patients—drives all that we do.It is key to our becoming ...Show moreLast updated: 11 days ago
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Engineer - Machine Programming

Engineer - Machine Programming

FlexChennai, India
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity...Show moreLast updated: 11 days ago
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NC Programming-2

NC Programming-2

Quest GlobalBengaluru / Bangalore, India
CNC programmer – Job Description : .Under close supervision, this position is responsible for acquiring expertise in creating quality NC part programs used on numerically controlled production machin...Show moreLast updated: 11 days ago
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Programming Analyst

Programming Analyst

Columbia Machine, Inc.Vadodara, India
The Programmer / Analyst must possess the desire and ability to perform complex analysis and application programming using. Net and Visual Studio against a SQL database back end.The Programmer / Analyst...Show moreLast updated: 11 days ago
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JAVA programming intern

JAVA programming intern

Mente ConsultanciesDelhi, India
Mente Consultancies is looking for JAVA programming interns at their office located in New Delhi.The internship will vary with an initial period of 3 months to 6 months with 2 weeks of induction tr...Show moreLast updated: 11 days ago
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Manager, Clinical Programming

Manager, Clinical Programming

Catalyst Clinical ResearchIndia, Cochin / Kochi / Ernakulam
Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative tech...Show moreLast updated: 5 days ago
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Freelance Python Programming

Freelance Python Programming

Rgb WebtechChandigarh
Collaborate with cross-functional teams to understand project requirements and translate them into technical solutions.Develop and maintain server-side components using Python and frameworks such a...Show moreLast updated: 11 days ago
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  • New!
NC Programming

NC Programming

L&T Technology ServicesBengaluru / Bangalore, India
NC Programming preferably in Aerospace.Preferred tool would be Catia V5 & UG NX ie Advance machining module (AM2).Hands on experience in optimum toolpath generation for 3, 4, & 5 Axis CNC machines....Show moreLast updated: 4 hours ago
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Associate Biostatistical Programming

Associate Biostatistical Programming

Amgen Technology Private LimitedHyderabad / Secunderabad, Telangana
In this vital role, you will collaborate with cross-functional teams across multiple time zones to fulfill programming requests, clarify requirements, escalate issues, and deliver high-quality resu...Show moreLast updated: 11 days ago
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Architect - Python Programming

Architect - Python Programming

Arting DigitalBengaluru / Bangalore, India
Location : Bangalore (Kalyan Nagar).Working Mode : Hybrid (3 days office / 2 days work from home).We are looking for an experienced Architect with a strong background in Python, scripting, and automa...Show moreLast updated: 11 days ago
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Database Programming Manager

Database Programming Manager

Astellas PharmaBengaluru / Bangalore, India
11 days ago
Job description

Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Purpose And Scope

  • The Technical Designer (TD) works as part of a project team to develop specification requirements, implement and maintain Medidata Rave clinical databases and system used to collect, review and clean data in Astellas's phase 1-IV clinical trials.
  • To translate functional requirements into detailed technical specifications that database programmers can implement.
  • Ensure technical feasibility, scalability, and alignment with organization level standards.
  • Act as a liaison between Database Programmers, Data Managers and clinical teams ensuring clarity and consistency.
  • The Technical Designer (TD) will actively search for solutions which reduce set-up times including increased automation of the set-up and will take a leading role in evaluation or improvement projects regarding data management applications or interfaces between data management systems and other applications.
  • Development and improvement of standards, templates, and process to improve efficiency and quality of databases / database set-up is expected along with a level of technical expertise that evokes innovation.

Technical

Responsibilities and Accountabilities :

  • Lead and manage study setup activities for multiple studies of varying complexity, adhering to established processes, standards, and timelines.
  • Designs, develop specifications, and tests clinical databases, including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.
  • Provides study-level support to teams and junior team members, assessing the protocol, evaluating alternatives, and facilitating resolution.
  • Creates, reviews, and approves technical specifications for data management systems.
  • Supports databases build specification development, including eCRFs, change requests, edit checks, custom functions, derivations, interface configuration, and migrations.
  • Help resolve metadata anomalies and quality issues.
  • Contributes to the creation of departmental documentation, such as training materials and process guides.
  • Continuously seeks improvements in processes and templates to enhance operational efficiency.
  • Oversee the activities of CRO vendors for outsourced data management systems, ensuring compliance with Astellas and industry best practices and timelines.
  • Maintains regular communication with CRO staff, addressing questions, resolving issues, and mitigating risks.
  • Provides expert-level technical guidance to junior team members, ensuring the delivery of high-quality results.
  • Identifies and communicates lessons learned, best practices, and frequently asked questions.
  • Maintains supporting documentation for studies and systems, ensuring quality, traceability, and compliance.
  • Helps end users understand challenges and analyzes current processes to ensure context, implications, and expectations are clearly represented in the final solution.

    • Quantitative Dimensions : Oversees the development and maintenance of 18-20 studies per year.

    Required Qualifications

  • Bachelor's degree in computer science or a related field, with at least 8 years of experience in the pharmaceutical industry.
  • A minimum of 4 years of experience in clinical trial database design and management, specifically with EDC systems such as Medidata Rave, including experience with Rave EDC
  • Strong proficiency in protocol analysis and interpretation, with the ability to accurately transcribe eCRF specifications from protocol.
  • Expertise in protocol schema mapping to database structures, ensuring accurate representation of study design elements such as arms, cohorts, visits, and endpoints.
  • Expertise in eCRF design, specifications development, and Data Validation Specifications (DVS) to ensure accuracy, compliance, and operational efficiency.
  • Deep understanding of therapeutic areas, including study objectives and endpoints.
  • Expertise in primary and secondary endpoints, Schedule of Activities (SOA), and safety data requirements, ensuring accurate representation in database design and compliance with protocol specifications.
  • Ability to manage screen review presentations, communicate effectively with cross-functional teams, and explain specifications prior to database build.
  • Proven ability to lead technical discussions, provide strategic input on database design, and collaborate with clinical, data management, and programming teams.
  • Skilled in stakeholder communication, including presenting complex technical concepts in a clear and concise manner.
  • Proficiency in test case creation for CRF UAT, Data Flow UAT, and Edit Check UAT, ensuring thorough validation and compliance.
  • Familiarity with QC, UAT, platform testing, and creating and executing test scripts.
  • Strong verbal and written communication skills, with the ability to collaborate effectively across multiple disciplines and regions.
  • Strong organizational skills and the ability to prioritize work to meet deadlines.
  • Excellent interpersonal and project management skills, with the ability to collaborate effectively with individuals at all levels and from diverse backgrounds.

    • Preferred Qualification

  • Familiarity with other Medidata modules (e.g., CTMS, RTSM, TSDV, Coder, Lab Admin) and their integrations.
  • Understanding of relational databases and data capture standards (e.g., CDSIC / CDASH).
  • Advanced computer skills, including proficiency in MS Office (Word, PowerPoint, Excel, Outlook), with the ability to manage complex data analysis and pivot tables.
  • Strong quantitative and analytical skills, with excellent critical thinking and problem-solving abilities.
  • Ability to manage multiple technical projects and provide training to team members.
  • Capacity to learn new technologies quickly and disseminate information effectively.
  • Ability to innovate and transform current industry practices into more efficient solutions.
  • Expertise in providing subject matter expertise, training, and mentoring to team members.
  • Ability to lead discussions on best practices and facilitate input from team members.
  • Ability to work independently and creatively within a collaborative, complex team environment.
  • Experience in CRF Completion Instruction (CCI) document creation and maintenance.
  • Proven ability to handle databases for complex protocols involving multiple cohorts, parts, or adaptive designs, including handling dynamic visit schedules and conditional logic.
  • In-depth understanding of the Drug Development Process, Software Development Life Cycle, Computer Validation Process, FDA regulations, ICH-GCP, and other relevant Health Authority Guidelines.
  • Solid understanding of database structures, programming languages, and integration of external data sources (e.g., IRT, RTSM, lab data, imaging, eCOA, safety systems).
  • Experience with Agile methodologies in clinical research and database development.
  • Ability to identify and mitigate risks in database design and implementation.
  • Experience in managing studies across multiple regions and therapeutic areas.
  • Experience in writing, programming, or configuring data validation checks.

    • Category Quantitative Sciences & Evidence Generation

    Astellas is committed to equality of opportunity in all aspects of employment.

    EOE including Disability / Protected Veterans

    Skills Required

    Test Case Creation, protocol analysis