General Dynamics Information Technology

We are helping a small pharmaceutical company for a senior contract statistical programmer position. The rate is very competitive.

Job Summary:

· Provide oversight for CROs deliveries including SDTM, ADaMs, TFLs, DMC, DSUR, interim analysis, final CSR analysis

· Provide programming support for internal production deliveries including SDTM, ADaMs, TFLs, DMC, DSUR, interim analysis, final CSR analysis

· Provide infrastructure support for internal programming team: set up and maintain standard directory, author technical user guides for utilities, draft good programming practices and department SOPs, make training materials for junior/new programmers

· Establish and maintain macro libraries that support biometrics clinical studies activities, including TFL generation, program index, 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 quality, efficiency and effectiveness within function

· Ensure compliance to standards and automation usage

· Identify manage and communicate risks within the assigned studies and/or projects. Work proactively with study team members and work cooperatively with contract programming providers Influence stakeholders by providing subject matter expertise on programming related items

· Contribute to or lead 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 SAS, including SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/ACCESS, SAS/BASE, SAS/STAT, SAS/ODS, SAS/EG, SAS/Studio, SAS/REPORT, SAS/ACCESS, SAS/UNIX, and SAS annotate facility;

· Must have extensive knowledge of CDISC standards to develop specifications and SAS programs for the creation of SDTM and ADaM data sets as well as the supporting documentation and complex statistical analysis reports;

· Must be fluent in generating summary tables, figures, listings and provide QC check

· Have done at least one complete submission experience with NDA/BLA/EMA within the past 5 years

· Extensive experience in annotate SDTM aCRF, trial design domains, RELREC

· Extensive experience in ADaM specification and programming of ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy)

· Extensive experience in creating CDISC submission package including define.xml, cSDRG, ADRG, CT

· Extensive knowledge of Pinnacle 21 and able 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