Overview
On Site
Full Time
Skills
CDISC
SAS
ADS
SAP
Mentorship
Project Management
Optimization
Standard Operating Procedure
Pharmaceutics
Biotechnology
Research
Specification Gathering
Management
SAS/BASE
SAS/MACROS
SAS/STAT
SAS/GRAPH
SAS/SQL
SDTM
Relational Databases
Good Clinical Practice
MedDRA
Job Details
Responsibilities:
- You'll be at the forefront of developing and validating programs that create datasets conforming to CDISC standards.
- Your expertise will drive the creation of Tables, Listings, and Figures for analysis purposes.
- Depending on the complexity of the study, you may lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
- You'll also have the opportunity to mentor junior programmers and represent Statistical Programming in meetings with internal and external clients.
- re you prepared to integrate statistical concepts with SAS Programming efficiently and effectively.
- Support development of technical programming specifications for SDTM, ADS or ADaM standards.
- Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications.
- Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
- Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications.
- Manage external vendors and contract programmers.
- Provide project progress updates of programming activities.
- Review, maintain, and approve protocol-specific documents as necessary.
- Provide guidance and mentoring to peer, junior-level Programmers and contract staff.
- Support project leadership ensuring that department standards are implemented in all studies.
- Contribute ideas and thoughts towards the optimization of standard operating procedures.
- Lead team meetings when appropriate.
- Independently and collaboratively resolve problems.
- Statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
- Clearly communicate processes and standards with management and team members.
- Competence in using SAS/Base, SAS/Macro, SAS/STAT.
- Knowledge of SAS/Graph, and SAS/SQL.
- Knowledge and implementation of.
- SDTM and ADaM principals.
- Relational Databases.
- Good Clinical Practice principals.
- Good Programming Practice principals.
- 21CFR Part 11 Standards principals.
- Integrated Summary Safety/Efficacy Analyses.
- Safety data and Coding Dictionaries (MedDRA and WHODD).
- ICH eCTD format.
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