Senior/Principal Statistical Programmer

Company: PAREXEL
Location: Edwardsburg
Posted on: January 16, 2022

Job Description:

What will you do as a Senior/Principal Statistical Programmer at Parexel? You will provide technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, liaise with sponsors, Data Operations Leads, and other functional areas as required. In addition, the Principal Statistical Programmer can fill the Primary Statistical Programmer role on projects and liaise with sponsors, Data Operations Leads, and other functional areas as required. Furthermore, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets. Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.Lead a statistical programming team to successful completion of a study within given timelines and budgetMonitor project resourcing, project budgets, and identify changes in scopeInteract with Sponsors as the key contact with regard to statistical programming issuesProvide technical support and advice to the internal teamCheck own work in an ongoing way to ensure first-time qualityEnsure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed. *Opportunities available for FSO and FSP modelsQualificationsRequired skills and experience:Knowledge of the programming and reporting process At least 8 years of Statistical Programming experience for a Principal level role and 5+ years of experience for a Senior level role 5 plus years of proficiency in SAS programming 2+ years of ADaM, CDISC or SDTMKnowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application Strong leadership ability with proven lead experience in a Pharma settingDemonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change. Attention to detail and excellent analytical skills Excellent communication skills (verbal and written) Language Skills:Competent in written and oral English.Excellent communication skillsEducation:Educated to degree level in a relevant discipline and/or equivalent work experienceEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, South Bend , Senior/Principal Statistical Programmer, IT / Software / Systems , Edwardsburg, Indiana