12 дней назад
Principal Stats Programmer (VAX)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Stats Programmer (VAX) (SAS/R/CDISC): Delivering statistical programming for vaccine research across pre-clinical, clinical, translational, and CMC activities with an accent on SDTM/ADaM datasets, integrated clinical databases, and compliant CDISC submissions. Focus on designing complex macros, pooling data across studies, preparing TLFs and e-submissions, and leading quality-controlled programming deliverables.
Location: Hyderabad, India
Company
is a global healthcare company developing vaccines and medicines to help protect people from infectious diseases.
What you will do
- Plan and deliver statistical programming activities across the vaccine R&D value chain.
- Review protocols, statistical sections, case report forms, and statistical analysis plans; create mock TLFs.
- Write programming specifications and deliver compliant CDISC SDTM/ADaM/TLF data packages with submission documentation.
- Build integrated clinical databases by pooling SDTM and ADaM data from multiple studies for ISS, ISE, ISI, DSUR, PBRER, and safety surveillance analyses.
- Develop exploratory and post-hoc analyses, perform quality control, and complete validation documentation.
- Lead complex studies and projects, guide junior staff, and ensure timely, high-quality delivery in compliance with SOPs and standards.
Requirements
- 8+ years of experience in statistical programming for clinical research, including experience with vaccine studies.
- More than 3 years of SAS experience with strong skills in Base, STAT, Macro, Graph, SQL, and R.
- Experience programming CDISC SDTM and ADaM datasets, including specifications, P21, controlled terminology, value-level metadata, analysis results metadata, define.xml, and reviewer guides.
- Experience solving complex programming problems, creating complex macros, pooling data across studies, and planning pooling specifications.
- Successful experience leading several concurrent studies or projects, with strong organization, critical thinking, teamwork, and project management skills.
- Bachelor’s or master’s degree in statistics, mathematics, computer science, or a related health sciences field, or equivalent experience. Highly effective written and spoken English is required.
Nice to have
- Experience preparing e-submissions.
Culture & Benefits
- Work within ’s Hyderabad Hub and collaborate with the Vaccines Global Biostatistical Sciences team.
- Contribute to vaccine research supporting public health and infectious disease prevention.
- Equal-opportunity workplace committed to diversity, equity, and inclusion.
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