Live opening · Posted 13 days ago

Senior SDTM Programmer with R

Veramed · Greater Bengaluru Area (Remote)
Linkedin No
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At a glance

The key details from the original listing.

Posted 13 days ago
CompanyVeramed
LocationGreater Bengaluru Area (Remote)
Work modeNo
SourceLinkedin
Listed13 days ago

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About the role

Description supplied by the original job listing.

About the Role
We are actively hiring for the role of the Senior Programmer I - this role is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas.
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
Responsibilities
Technical:
SDTM Dataset Development
Develop and review SDTM mapping specifications.
Interpret protocol, CRF (Case Report Form), and data management documents to define mappings.
Program SDTM datasets using R.
Perform independent validation/QC of SDTM datasets and associated outputs.
Resolve discrepancies and document findings.
Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
Author and review simple and complex dataset standards
Perform data checks and data exploration (e.g. using frequencies, histograms)
Complete and review CDISC Validation tool reports
Ensure the appropriate standards are being applied and adhered to
Familiarization with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
Review of project management related documents
Maintain study master file documents and any other documents that are required to be audit ready
General:
Lead internal and client study team meetings effectively
Present study updates internally and at client meetings
Share scientific, technical and practical knowledge within the team and with colleagues
Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
Build effective collaborative working relationships with internal and client team members
Seek opportunities to develop innovative ideas, sharing when appropriate
Line management or mentorship of more junior team members
Contribution to development of internal training materials
Contribution to internal process improvement initiatives
Qualifications
Degree in a relevant field such as Mathematics, Life Sciences, Statistics, Computer Science, etc.
At least 5+ years of relevant industry experience
Required Skills
Strong hands-on experience with R Programming.
5+ years of hands-on experience in developing CDISC SDTM datasets.
Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
Good knowledge of CDISC standards and clinical trial processes
Knowledge of CDISC SDTM Implementation Guide, Define.xml, Pinnacle 21
Experience reviewing protocols, SAPs, CRFs, and CSR documents
Awareness of industry and project standards & ICH guidelines
Demonstrated problem solving ability and attention to detail
Ability to work independently and as part of a team
Excellent verbal and written communication skills
Interpersonal/teamwork skills for effective interactions
Self-management skills with a focus on results for timely and accurate completion of competing deliverables
Equal Opportunity Statement
We are committed to diversity and inclusivity.
About Veramed:
Veramed is a biometrics-focused CRO, primarily specializing in Statistics and Statistical Programming. Recently, we have also started expanding into Data Management and are in the process of building dedicated data management teams across the UK, US, and India. The company was founded in 2012 by Matthew Jones, a Statistical Programmer, and Emma Jones, a Statistician. Over the past 13 years, Veramed has grown significantly and now has a global workforce of around 750-800+ employees. We have a strong international presence, with three offices in the UK, two offices in Ukraine, and teams located in Spain, Germany, France, and the United States. In India, we launched our operations in March 2024, and within just two years we have grown to 170 employees, including contractors. Currently, we have an office in Bangalore, and our second office in Hyderabad will be launching soon. One of our key strengths is our employee retention, with a strong retention rate of around 92–93% globally. This role offers an excellent opportunity to work alongside experienced professionals, contribute to meaningful clinical research projects, and further develop your technical and programming skills in a collaborative environment

Work arrangement
No

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