Clinical Programmer

SDC (Statistics & Data Corporation); Hyderabad; On-site; INR 500,000 - 900,000; Full time

Benefits offered by this job

Flexible work schedule

Career development opportunities

Employee benefits & culture programs

Job summary

SDC (Statistics & Data Corporation) is seeking a candidate to design and implement clinical database applications supporting clinical research and biostatistics analysis. You will collaborate with clinical data managers and biostatisticians to develop database build specifications and gain acceptance through user testing.

Responsibilities include developing data entry screens, implementing data quality checks, and documenting all work per FDA regulations and company SOPs.

Qualifications

• 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.
• Able to provide both "user-friendly" and technical documentation
• Excellent written and verbal communication skills
• C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge / experience not required, but desirable

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
• Utilize copies of like database elements from library structures or other similar studies during builds
• Assist in batch loading external data from vendors (e.g., central lab data)
• Assist in management of user access to clinical databases
• Participate in writing departmental documentation (e.g., training documents, process guidances)
• Participate in other clinical programming and data management activities, as required
• Adhere to all aspects of the SDC's quality system
• Comply with SDC's data integrity & business ethics requirements
• Perform other duties as assigned
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Skills

Relational databases

PL/SQL/SQL/XML programming

Interpersonal skills

Documentation skills

Written and verbal communication

OO languages (C++, .NET, VB or SAS)

Education

Bachelor's degree in computer science or related field

Commensurate experience in clinical database programming/DBA

Job description

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. Communicates database build, edit check programming and related document review statuses to management and the project teams.

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
• Utilize copies of like database elements from library structures or other similar studies during builds
• Assist in batch loading external data from vendors (e.g., central lab data)
• Assist in management of user access to clinical databases
• Participate in writing departmental documentation (e.g., training documents, process guidances)
• Participate in other clinical programming and data management activities, as required
• Adhere to all aspects of the SDC's quality system
• Comply with SDC's data integrity & business ethics requirements
• Perform other duties as assigned
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

Requirements

Required Skills

• 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
• Able to provide both "user-friendly" and technical documentation
• Excellent written and verbal communication skills
• C++, .NET, Visual Basic or other object-oriented language, and/or SAS programming knowledge / experience not required, but desirable

Education Or Equivalent Experience

• Bachelor's degree in computer science or other related quantitative or scientific discipline.
• Commensurate experience with clinical database programming and database administration will be considered as an alternative to a degree

Benefits

Why SDC

• 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

Take a look at how you can join our team!