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As a member of Parexel’s Statistical Programming group, you analyze, summarize, and graphically present clinical data to assess the safety and efficacy of the clinical trial. It requires attention to detail, a commitment to quality, and effective communication to ensure new treatments reach patients faster. You will work in different therapeutic areas assessing a variety of data entries and endpoints in an ever-changing environment. We provide a fertile environment for growth, with extensive training, mentoring, and technical knowledge sharing. You will work closely with the client and Parexel teams and collaborate to maximize the collective strength. Experience a supportive and motivating work environment where our teams offer an inherent breadth of knowledge within a diverse and inclusive workplace.
Job Responsibility:
Provide technical support and expert advice to internal and external sponsors on statistical programming projects to support clinical trial activities
Work independently to support various programming activities related to analysis and reporting of clinical study data
Fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas
Monitor quality, timelines, resource allocation, and productivity in relation to budget
Project management for statistical programming
Advise and negotiate statistical programming timelines
Requirements:
Bachelor's in Statistics, Mathematics, Pharmaceutical Science, Data Analytics or related field. Employer will accept post-secondary academic coursework and/or relevant work experience which is evaluated as equivalent to a U.S. Bachelor’s degree in accordance with 8 CFR § 214.2(h)(4)(iii)(D)
7 years of progressive experience in statistical programming
7 years of experience with: Programming and reporting process
FDA 21 CFR Part 11 regulations
Regulatory requirements (ICH-GCP, CDISC, and electronic submissions)
Analyzing data from Phase I, II, and III clinical trials
SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Step, Proc Step, and Functions
Generating reports, tables, and listings for statisticians
Building structured, CDISC, SDTM, or ADaM databases for clinical studies
Leading teams in a statistical programming environment
Pinnacle 21 for CDISC compliance validation
and R programming for statistical analysis and visualization