Sr. Statistical Programmer

Katalyst Talent Agency

Omaha, NE, United States

14 days ago

Prepare application

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

5 years minimum

Working hours

Regular working hours

Job source

Coherent Remote File System (CRFS) SAS (Software) SQL Databases Programming Logic Data Management

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

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

This job is hosted externally. Click below to view the full posting and apply.

Prepare application

Loading talks and stories from around this role…