Match score not available

Principal Statistical Programmer

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

Minimum 10+ years of statistical programming experience in life science industry and relevant bachelor's degree, Experience with NDA submissions, SAS programming, SDTM, ADaM industry data standards, and define.xml.

Key responsabilities:

Write specifications for SDTM and analysis datasets, develop algorithms and create datasets
Produce data listings, summary tables, and graphs using SAS software, and check their accuracy independently
Assist data management group with data edit checks and interact with project statisticians
Generalize project solutions for Biostatistics group and ensure compliance with regulatory requirements
Interact with other programmers, guide project team, and assist with e-submission experience

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
Following specifications, develops algorithms and writes programs to create datasets.
Produces data listings, summary tables and graphs using SAS software.
Independently check data listings, summary tables and graphs.
Imports and exports SAS data.
Assists data management group in performing data edit checks.
Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
Plays an active role in taking project solutions and generalizing them for the Biostatistics group.
Interacts with the project statistician and guides other programmers participating on a project team.
Experience with Pooled analysis, regulatory agencies requirements and e-submission experience.

Requirements:

Minimum of 10+ years of statistical programming experience in the life science industry and relevant bachelor's degree
Must have recent NDA submissions experience.
ISS/Client safety & efficacy experience is required.
Experience creating define.xml and experience with Pinnacle 21 and specifications.
SAS Certified Base and/or Advance Programmer experience is preferred.
Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS.
Experience with SDTM and ADaM industry data standards.
Good communication skills and attention to detail are crucial.
Proven ability to handle multiple tasks.
Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.