Statistical Programmer

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• This person will be responsible for development and generation of analysis datasets, tables, listings, and graphs from assigned clinical sources using SAS and/or R; leading development and maintenance of associated operating procedures; and participating in external industry forums (e.g., CDISC, SDTM, and relevant User Groups).
• This individual performs with minimal guidance on moderately difficult deliverables.
• Utilize programming standards to develop efficient and accurate programs using SAS and/or R.
• Support creating and/or maintaining Programming Infrastructure in SAS and/or R.
• Support in developing and maintaining R scripts for data analysis, statistical modelling, and visualization is a plus.
• Keeping up to date with the latest R packages, techniques, and best practices is desirable.
• Work with Data Management leadership to provide input on reporting processes and standards.
• Support programming deliverables for clinical trials and support for any custom Data Management reports.
• Participate in the development and maintenance of global harmonized processes and procedures for programming.
• Provide quality programming deliverables.
• Facilitate the delivery of standard metric reports.
• Ability to design, implement and maintain moderately complex programming deliverables across a wide variety of clinical platforms and thereputic areas.
• Conduct independent QC programming and peer review of code and deliverables.
• Demonstrated ability work in teams to deliver critical milestones.
• Connect – Participate in strategic partnerships with Clinical and Biostatistics functions at the Enterprise level to ensure MD programming practices meet the needs of the organization.
• Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and SDTM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine SDTM standards.
• Lead – Present opportunities in programming practices that increase quality of deliverables.
• Deliver – ensure high quality programming deliverables for clinical programs are delivered on time and in compliance to regulations and SOPs, seamlessly across all Franchises.

Requirements:

• A bachelor's degree in Statistics, Computer Science or related discipline (required).
• Minimum 4 years of system support in clinical research within Medical Device or Pharmaceuticals.
• Proficiency in Base SAS, SAS/STAT and SAS Macro language.
• Strong debugging, problem-solving, and documentation skills.
• Excellent verbal and written communication skills.
• Support the maintenance of established SAS platform.
• Support the maintenance of a global SAS macro library.
• Work with Clinical Data Science (CDS) partners, and leadership in Clinical Operations and Franchise to set implement plans for timely delivery of reports, metrics, and study deliverables.

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