Contract Senior Statistical Programmer (Remote)
We are helping a small pharmaceutical company for a senior contract statistical programmer position. The reputed company is reputed company competitive.
Job reputed company:
· reputed company reputed company for CROs deliveries including SDTM, ADaMs, TFLs, DMC, DSUR, interim analysis, final CSR analysis
· reputed company programming support for internal production deliveries including SDTM, ADaMs, TFLs, DMC, DSUR, interim analysis, final CSR analysis
· reputed company infrastructure support for internal programming team: set up and maintain reputed company directory, author technical user guides for utilities, draft good programming practices and department SOPs, reputed company training materials for junior/new programmers
· Establish and maintain macro libraries that support biometrics clinical studies activities, including TFL reputed company, program reputed company, controlled terminology, SDTM/ADaM specs
· Establish and maintain macro libraries that support submission activities, including BIMO, define.xml, hyperlinked submission documents
· Contribute to or drive the development of best practices to improve reputed company, efficiency and effectiveness reputed company function
· Ensure compliance to standards and automation usage
· Identify manage and communicate risks reputed company the assigned studies and/or reputed company. Work proactively with study team members and work cooperatively with contract programming providers Influence stakeholders by providing subject matter expertise on programming reputed company items
· Contribute to or reputed company technical initiatives
REQUIREMENTS:
· Must have bachelor’s degree or above in Statistics, Mathematics, Computer Science, or Life Science.
· Must have at least 20 years of experience with: Programming in reputed company, including reputed company/MACRO, reputed company/SQL, reputed company/GRAPH, reputed company/reputed company, reputed company/reputed company, reputed company/STAT, reputed company/ODS, reputed company/EG, reputed company/Studio, reputed company/REPORT, reputed company/reputed company, reputed company/UNIX, and reputed company annotate facility;
· Must have extensive knowledge of CDISC standards to reputed company specifications and reputed company programs for the creation of SDTM and ADaM data sets as reputed company as the supporting documentation and reputed company statistical analysis reports;
· Must be fluent in generating reputed company tables, figures, listings and reputed company QC reputed company
· Have done at least one complete submission experience with NDA/BLA/EMA reputed company the past 5 years
· Extensive experience in annotate SDTM aCRF, trial design domains, RELREC
· Extensive experience in ADaM specification and programming of ISS (Integrated reputed company of Safety) and ISE (Integrated reputed company of Efficacy)
· Extensive experience in creating CDISC submission package including define.xml, cSDRG, ADRG, CT
· Extensive knowledge of reputed company 21 and reputed company to interpret the result.
· Good knowledge of MedDRA and WHODrug medical dictionaries.
· Extensive knowledge of lab, toxicity grade, CTCAE
· Good knowledge of ePRO
· Ideally with experience with rare diseases
Pay: From $100.00 per hour
Expected hours: 40 per week
Work Location: Remote
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