Associate Director, Statistical Programming FibroGen
THIS JOB HAS EXPIRED Description:
The primary activities of the Associate Director, Associate Director, Statistical Programming, are to develop and review SAS(r) programs and output for the management and reporting of clinical trial data and act as a Lead Programmer for increasingly complex or multi-protocol projects
The Associate Director, Statistical Programming, will be a primary resource for the development and validation of programs which create datasets conforming to FibroGen and ADaM specifications, as well Tables, Listings, and Figures (?TLFs?). He/she will 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. He/she will represent Clinical and Statistical Programming in meetings and cross-functional project teams. He/she must demonstrate the ability to comprehensively integrate statistical concepts with SAS Programming in an efficient and effective manner. He/she must also communicate well with other stake-holders in translating concepts/requirements into technical specifications and providing our customers with sensible programming solutions.
The Associate Director will also assist the Head of Biometrics in reviewing bid proposals and in monitoring and tracking budgets for outsourced activities. He /she will assume the lead position for a compound in development.
Act as the Lead Programmer for assigned projects.
Lead programming efforts for the preparation of electronic submissions.
Ensure quality of personal work and the work of the team when acting as a Lead Programmer.
Interact with project team members in related disciplines e.g. Data Management, Clinical, and Biostatistics.
Assume team member responsibilities, including representing Statistical Programming at internal project team meetings, and audits.
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.
Assist the Head of Biometrics in reviewing bid proposals and in monitoring and tracking budgets for outsourced activities. He /she will assume the lead position for a compound in development.
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 FibroGen or ADaM specifications.
Independently develop and validate programs that generate tables, listings, figures/graphs using FibroGen specifications.
Master?s Degree in Computer Science, Biostatistics, Statistics, or a related quantitative discipline and a minimum of 15 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
Additionally, the successful candidate must minimally possess abilities in the following:
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.
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.
||San Francisco, CA |
THIS JOB HAS EXPIRED