JGB BioPharma Consulting Inc. - Statistical Programmer Contract

 

Statistical Programmer Contract

Company:
JGB BioPharma Consulting

Location:
San Francisco Bay Area, California

Contact Person:
Sage St. Clair

Phone, Email, Postal Address:
(650) 627-7652
sstclair@jgbbiopharma.com

How to Apply:
Email: sstclair@jgbbiopharma.com

# of Openings: 1

Abstract:

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”).

Requirements:

  • – 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.

Responsibilities:

  • – 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