Senior Statistical Programmer (ADaM + R Prog)
Veramed · India ·
- Seniority
- Senior
- Employment
- Full time
- Experience
- 5+ years
Senior statistical programmer supporting clinical trials across clients and therapeutic areas: programming and QC of ADaM/SDTM datasets and TFLs in SAS, CDISC validation, data checks/exploration, and mentoring junior team members. Core tech is SAS and R with CDISC standards.
Purpose
The role of the Senior Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas.
Key Responsibilities:
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
Technical:
• Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
• Author and review simple and complex study TFL shells
• Author and review simple and complex dataset standards
• Perform data checks and data exploration (e.g. using frequencies, histograms)
• Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice
• Complete and review CDISC Validation tool reports
• Ensure the appropriate standards are being applied and adhered to
• Familiarisation 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
Minimum Qualification Requirements
- BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
- 5+ years of hands-on experience in creation & Validation of ADaM, SDTM datasets
- 5+ Years of experience in TLF
- R programming experience is a must - preferably expert level
Other Information/Additional Requirements
• Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Proficiency in data handling using SAS or other statistical software (e.g. R)
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Ability to work independently and as part of a team
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.