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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:
Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures
Perform programming validation to ensure quality of analysis datasets and programming outputs
Provides programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
Support the electronic submission preparation and review
Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements
Assesses impact on programming activities
Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
Provides leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices
Identifies opportunities for increased efficiency and consistency within team and our interactions with strategic vendors
Independently leads and / or performs programming assignments with minimal supervision
Support improvement initiatives
Requirements:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required
Proficiency in SAS
Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development
Demonstrated proficiency in analytical programming
Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21
Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
Have good understanding of regulatory, industry, and technology standards and requirements
Have good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
Demonstrated ability to work in a team environment with clinical team members