Emcure Pharmaceuticals - Principal Statistical Programmer - SAS Platform

Job Description

Location : Mumbai & Chennai. Skill : SDTM, ADAM and TLF. Exp : 5+ years core experience in Clinical SAS Programming is mandatory. Jd An Individual Contributor role : Productive hands-on programming, supporting deliverables in the study/project/portfolio/standards team, of medium to high complex statistical programming deliverables to support assets and study teams. Performs tasks independently with mentorship or advise from Programming Leads within the organization. Acts as co-lead/lead on selected projects/initiatives/activities and also study deliverables as needed. Guide, mentor, monitor programmers within the team and collaborate with SDSL's on timelines, resource management and deliverables with quality. Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones. Ensures adherence to high quality programming standards in their daily work. Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance. Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables. Active self-learning and delivering on solutions in the space of statistical programming and data standards. Contribute to SDSA initiatives globally and locally. Skills Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field. At least 5 6 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. Understanding of clinical data and drug development process, CDISC standards required. Statistical Programming and SAS hand-on experience. Clinical trials expertise with an understanding of data operations required for the reporting of clinical. Good understanding of ICH and regulatory guidelines. Working knowledge of clinical data and relevant data standards. Is able to work with stakeholders across timezones under tight timelines. Strong written and oral communication skills, and time and project management skills. Strong competencies and interests for innovation and problem solving. Proven ability to operate with limited oversight. Knowledge of at least 1 Therapeutic Area. (ref:hirist.tech) Show more Show less