Senior Statistical Programmer (Clinical Sas Programmer), South Africa

When our values align, there's no limit to what we can achieve.

Parexel is currently seeking a Senior Statistical Programmer to join us in South Africa, dedicated to a single sponsor.

Picture Yourself At Parexel :

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.

What You'll Do At Parexel :

• 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.

Role Requirements :

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• 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 database.
• 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.

Additional Requirements :

• Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings.
• Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
• Experience in other software packages (e.g., R)
• Experience with the Linux operating system.