Join a sponsor-dedicated team, progressing with in-house study activities over the years. Experienced R programmer needed to provide technical expertise for Biostatistics department to meet internal and external needs.
Lead the sponsors Biostatistics group R implementation team.
- Develop internal and external R packages for clinical trial analysis (ADaM, tables, figures, listings).
- Validate R packages.
- Lead implementation in R and train other Biostatistics team members.
- Conduct statistical programming work of clinical data using R.
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
- Create and / or validate all safety and efficacy study output requirements (e.G. ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.
G. Protocol, SAP, aCRF)
Collaborates with peers and statisticians to ensure the quality and accuracy thus submission readiness of clinical data as required by authorities (i.
E. SDTM, ADaM, tables, figures, listings, define.Xml).
Qualifications :
- Approximately 5 years or more in R programming for clinical trial data (Tidyverse, etc.), including developing and validating R packages.
- Bachelor s degree in Math, Stats, Computer Science or similar
- Git / GitHub knowledge
- Knowledge of pharmaceutical clinical development (i.E. Understanding of safety deliverables and efficacy analysis supporting regulatory submissions)
- CDISC experience
- SAS experience a plus
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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