Senior Clinical Programmer

Statistics & Data Corporation; Hyderabad; Sur place; INR 1 200 000 - 2 600 000; Plein temps

Résumé du poste

Statistics & Data Corporation (SDC) seeks a Senior Clinical Programmer to design and implement clinical database applications supporting research and biostatistics. You will work with data managers and statisticians to translate specifications into robust database builds and testing.

Mentoring junior programmers and ensuring compliance with FDA guidelines are key aspects. The role emphasizes developing data entry screens, data quality checks, and documentation according to SOPs and regulatory

Qualifications

• Bachelor's degree in computer science or a related field with 6+ years of programming experience.
• Six+ years leading database programming, with at least 3 years in a clinical environment.
• Familiarity with FDA regulations and guidances (e.g., 21 CFR Part 11) is preferred.

Responsabilités

• Assist in developing, validating, and maintaining clinical databases for trials.
• Document study databases in line with SOPs and data management plans.
• Build and validate data entry screens for electronic data capture (EDC).
• Implement and test data quality checks per validation manuals.
• Mentor junior clinical programmers and support project teams.

Connaissances

Lead database programming

Relational databases

SQL/PL/SQL

FDA regulations knowledge

Formation

Bachelor's degree in CS or related field

Description du poste

• Industry Pharma/Biotech/Clinical Research
• Work Experience 7-10 years
• Country India

About Us

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Description

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Senior Clinical Programmer

Job Summary

Works as part of a project team to design and implement clinical database applications in support of clinical research and biostatistics analysis. Works with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing. Develops data entry screens and programs, and data quality edit checks to comply with related specifications. Accomplishes database structure testing. Processes database programming change requests. Documents all work fully according to FDA regulations and guidances, and company SOPs. Actively promotes standards for the development and acquisition of systems. Communicates with the end-users. Mentors/trains junior level clinical programmers.

Primary Responsibilities

• Assist in developing, validating, and maintaining clinical databases for clinical trials using a variety of validated software applications
• Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management plans
• Build and validate data entry screens (paper and/or electronic data capture (EDC))
• Implement and test data quality checks in accordance with the study data validation manual
• Assist in developing and maintaining global library of clinical database forms, edit checks, and other regularly used programs and routines
• Utilize copies of like database elements from library structures or other similar studies during builds
• Batch load external data from vendors (e.g., central lab data)
• Participate in internal and external team meetings, as necessary
• Assist in management of user access to clinical databases
• Assist in managing and updating medical coding dictionaries, including but not limited to MedDRA and WHODrug
• Participate in other clinical programming and data management activities, as required
• Mentor junior level clinical programmers
• Adhere to all aspects of the Statistics & Data Corporation’s quality system
• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

Required Skills

• At least six years’ experience assuming lead database programming responsibilities on projects, with a minimum of 3 years in a clinical environment
• Excellent understanding of relational database structures
• Fast, accurate programming skills using assorted application software
• PL/SQL, SQL, and XML programming skills
• Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships
• Demonstrated ability to provide both “user-friendly” and technical documentation
• Ability to provide expertise to guide department in continued efficiency and growth
• Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP)
• Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment
• C#, C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge / experience not required, but desirable
• Medidata Rave and iMedNet EDC knowledge / experience not required, but desirable
• Reporting application development (e.g. JReview, Business Objects, Spotfire) knowledge / experience not required, but desirable

Education or Equivalent Experience

• Bachelor’s degree in computer science or other quantitative or scientific discipline with 6+ years’ experience in database programming and demonstrated working knowledge of scientific principles.
• Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.