Senior/Principal Statistical Programmer
Company: Spectrum Pharmaceuticals Inc.
Posted on: July 15, 2019
Summary: This position is responsible for leading Statistical
Programming activities including hands-on programming of
statistical analysis and datasets. The person is responsible for
statistical programming deliverables of Phase I-IV clinical trials
and to provide input to specifications to ensure that the
clinical/statistical programming elements are in line with the
overall deliverables and to ensure adherence to ICH guidelines,
Good Clinical Practices, and regulatory requirements.
- Represent Clinical and Statistical Programming in meetings with
internal cross-functional and external customers
- Act as the primary department contact, when necessary, to
ensure that department standards are implemented in all studies
- Work closely with statisticians, and medical monitors for
pre-specified and ad hoc study data analyses; work with data
management personnel to identify data issues
- Generate SDTM datasets, ADaM datasets, tables, listings,
figures and project specific macros and formats; import/export
external data from/to other platforms and other software
- Prepare data specifications describing all datasets and
- Perform data checks as needed, to ensure integrity and
correctness of data displays, prepare documentation for
- Program customized data displays, (including data listings,
summary tables and routine graphics) in accordance with approved
statistical analysis plan and shell displays for clinical research
studies. Code is to be written using Base SAS programs, SAS
procedures, or standardized macros. Perform data checks as needed
to understand structure and content of data.
- Perform external data loads, i.e., labs, ECGs, etc., as needed
and perform data reconciliations
- Develop and validate technical programming specifications for
transforming raw data using SDTM standards
- Review CRFs/eCRFS, edit check specifications and table
mock-ups; maintain and approve protocol specific documents as
Skills, Education and Experience:
- 4 year degree in life Science, Computer Science or equivalent;
- 6-8 years statistical programming experience in the
Pharmaceutical, Biotechnology, or Contract Research Industry.
- Ability to clearly communicate processes and standards with
management and team members.
- Knowledge of clinical database design, specifically electronic
- proficiency in SDTM models and experience transforming raw data
into those standards.
- Knowledge of creating all necessary files, documents and
analyses to support electronic submissions In eCTDformat
- Knowledge of:
- Data Management and Pharmacovigilance processes in clinical
- Relational databases.
- Good clinical practices.
- Good programming practices.
- 21CFR Part 11 standards.
- Integrated summary safety/efficacy analyses for regulatory
- Safety data and coding dictionaries
Position location and/or Territory and Travel
- Position is located in Irvine, CA.
Keywords: Spectrum Pharmaceuticals Inc., Irvine , Senior/Principal Statistical Programmer, IT / Software / Systems , Irvine, California
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