Statistical Programmer Contract
JGB BioPharma Consulting
San Francisco Bay Area, California
Sage St. Clair
Phone, Email, Postal Address:
How to Apply:
# of Openings: 1
Develop and review SAS(r) programs and output for the management and reporting of clinical trial data and act as a Programmer for increasingly complex or multi-protocol projects. Will be a primary resource for the development and validation of programs which create datasets conforming ADaM specifications, as well Tables, Listings, and Figures (”TLFs”).
- – BS Degree (MS preferred) in Computer Science, Biostatistics, Statistics, or a related quantitative discipline.
- – Minimum of 7 of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- – Knowledge of using SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment to develop and validate analysis datasets, tables, listings, and figures/graphs.
- – Ability to clearly communicate processes and standards with management and team members.
- – Constructing technical programming specifications.
- – Working in a team environment.
- – Leading projects and teams.
- – Knowledge of CDISC SDTM and ADaM models and experiences in transforming raw data into those standards.
- – Knowledge of Relational Databases.
- – Good Clinical Practices.
- – Good Programming Practices.
- – 21CFR Part 11 Standards.
- – Integrated Summary Safety/Efficacy Analyses, NDA/ BLA submissions.
- – Safety data and Coding Dictionaries (MedDRA and WHODD).
- – Creating all documents necessary to support an electronic submission in the eCTD format.
- – Spotfire experience preferred.
- – Provide input to specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
- – Represent Clinical and Statistical Programming in meetings and cross-functional project teams.
- – Must demonstrate the ability to comprehensively integrate statistical concepts with SAS Programming in an efficient and effective manner.
- – Must also communicate well with other stake-holders in translating concepts/requirements into technical specifications and providing our customers with sensible programming solutions.
- – Participate in programming efforts for the preparation of electronic submissions.
- – Ensure quality of personal work and the work of the team.
- – Interact with project team members in related disciplines e.g. Data Management, Clinical, and Biostatistics.
- – Develop SAS programs for ad hoc tables, listings, and graphs. Write, modify, and maintain programs that produce diagnostics and listing for data review in support of Data Management.
- – Carry out electronic data transfer (both incoming and outgoing). Develop and review programs to ensure the data transfer has been produced to specification.
- – Review and interpret Report and Analysis Plans and provide comments for assigned projects.
- – Set up programming environment and utilities to assist and facilitate Clinical Data Management activities.
- – Review draft and final production runs for projects to ensure quality and consistency.
- – Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
- – Carry out all activities according to Good Clinical Practice (GCP). Ensure adherence to programming guidelines.
- – Independently develop and validate programs that generate analysis datasets based on or ADaM specifications.
Operating Systems: Spotfire
Date Posted: 8-8-2019