Senior SDTM Programmer (R Prog)
Veramed · India ·
- Seniority
- Senior
- Employment
- Full time
- Experience
- 5+ years
- Company size
- 501-1000
A senior statistical programmer at a biometrics-focused CRO, building and validating CDISC SDTM clinical trial datasets in R, writing and reviewing mapping specifications, performing QC and Pinnacle 21 validation, reviewing clinical documents, and mentoring junior team members across client projects.
Position: Senior Statistical Programmer
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
About the Role
We are actively hiring for the role of the Senior Programmer 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.
Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.