Sr. Statistical Programmer

Katalyst CRO; Omaha (NE); On-site; USD 75,000 - 90,000; Full time

Job summary

A clinical research organization is seeking an experienced statistical programmer to manage programming deliverables for clinical trials. The ideal candidate will have a strong background in SAS programming, CDISC standards, and experience leading studies. Responsibilities include developing programming efficiencies and collaborating with stakeholders. This role requires excellent communication skills and the ability to mentor junior staff. A solid understanding of the clinical trials process, especially in ophthalmology, is preferred.

Qualifications

• 5+ years of experience supporting clinical trials for regulatory submissions.
• Strong history as a study or program lead preferred.
• Experience with ophthalmology is a plus.

Responsibilities

• Ensure statistical deliverables are programmed and validated as per regulatory standards.
• Lead and manage statistical programming priorities for clinical studies.
• Mentor junior statistical programmers.

Skills

SAS programming skills

SQL

CDISC standards knowledge

Statistical methodologies

Cross-functional collaboration

Communication skills

Planning and organizational skills

Education

Bachelor's or master's degree in Biostatistics, Statistics or related field

Tools

Pinnacle21

Job description

Responsibilities

• Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies.
• Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools
• Maintains a basic understanding of relevant industry trends in standards implementation, clinical statistical programming, and ophthalmology
• Provides technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical programming services. Supports collaboration with Data Management to facilitate SDTM development
• Develops programming efficiencies (eg, local macros) to ensure efficient programming work
• Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics
• Develops specification documents for datasets, and all other supporting documents (eg, define.xml, annotated CRFs, reviewer\'s guides)
• Develops programming efficiencies (eg, global macros) to ensure consistent and efficient work across studies
• Leads and manages statistical programming priorities and task assignments for clinical studies and submissions
• Tracks and escalates concerns related to changes in scope of services
• Mentors junior statistical programmers

Requirements

• Bachelor\'s or master\'s degree or international equivalent in Biostatistics, Statistics, or programming-related field
• 5 or more years of experience supporting clinical trials for regulatory submissions with sufficient experience as a study or program lead, preferred
• A high level of SAS programming skills including SQL and macro development
• Good knowledge and application of CDISC standards for SDTM and ADaM
• Experience with Pinnacle21 and writing reviewer\'s guides is a plus
• Basic understanding of standard statistical methodologies is expected
• Experience with ophthalmology is preferred
• Good understanding of statistical programming topics in medical product development
• Excellent technical and programming logic skills
• A successful history of cross-functional collaboration
• Sound knowledge of all relevant regulations and guidelines
• Excellent verbal and written communication skills
• Good planning and organizational skills with the ability to adapt and adjust to changing priorities
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment
• A strong interest in developing expertise in ophthalmology