Senior Statistical Programmer
Phone, Email, Postal Address:
# of Openings: 1
The Senior Statistical Programmer reports to the Director of Statistical Programming and is responsible to provide support for internal and contract statistical programming teams for multiple drug development programs in all phases of clinical development. This person will be an active team member in developing programs that generate analysis, datasets, produce tables, figures, and listings, validate statistical programs, write general SAS applications, and prepare documentation for electronic submissions as required. The incumbent will also participate in the review and evaluation of new technologies to improve efficiency and productivity as requested.
- – Accountable for timely and quality development and validation of all statistical programming deliverables as assigned.
- – Responsible for validation of statistical programming deliverables as well as accuracy and reliability of tables, figures, and listings including maintaining and/or reviewing validation documentation at the study level.
- – May act as lead programmer for some statistical programming deliverables.
- – Ensures statistical programming output meets ICH/GCP quality requirements in support of product development.
- – Participates in giving feedback on the development and administration of the clinical programming group policies and procedures (SOPs) to ensure compliance with regulatory standards and the achievement of a high quality and efficient clinical programming support function.
- – Participates in evaluation and selection of new computing technology and programming practices for continuous improvement of clinical programming.
- – Builds and maintains effective working relationship with cross-functional teams including Biostatistics, Data Management, and Clinical Operations, as well as contract research organizations.
- – Develops and/or reviews programming specifications for SDTM and ADaM as needed.
- – Participates in giving feedback on processes used by the Statistical Programming group to ensure processes are complied with and updated as necessary.
Skills / Education Requirements:
Bachelor’s degree in Biostatistics, Computer Science or other related fields.
Master’s or PhD degree in Biostatistics, Statistics, Computer Science or other related field.
– 5+ years statistical programming within pharmaceutical industry.
Qualifications (Minimum Required):
- – General ability to summarize and discuss status of deliverables and critical programming aspects (e.g. timelines, scope, resource plan) to Biometrics management.
- – Advanced knowledge of SAS/Base, SAS/Macro, SAS/Stat, SAS/Graph, SAS GTL and SAS/SQL in a windows environment.
- – Excellent verbal and written communication skills and the ability to clearly and effectively present information.
- – Excellent analytical, problem solving and organization skills with the ability to work on multiple tasks.
- – Flexible to changing priorities, detail-oriented, and ability to work well under pressure with initiative to take on unfamiliar tasks.
- – Demonstrated ability to establish and articulate a plan to ensure appropriate focus and direction.
- – Experience using industry standards such as CDASH, SDTM, and ADaM.
- – Demonstrates a sound understanding of CDISC principles and guidelines with a focus on SDTM and ADaM.
Date Posted: 9-18-2019