Senior Statistical Programmer

Location
San Diego, California
Posted
Mar 27, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Senior Statistical Programmer will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies. 

ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):

  • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
  • Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Review output across SAS programs to ensure consistency.
  • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Assist Clinical Data Managers with data review via SAS programmed data checks and listings.
  • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Participate in the development and/or maintenance of departmental procedures and standards.
  • Review CRFs, edit check specifications, and table mock-ups.
  • Work collaboratively with cross functional groups, study team, and vendors.
  •  May assist in creation of table, figure, or listing mockups under supervision of statisticians.

QUALIFICATIONS:

  • Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
  • Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
  • Demonstrate extensive knowledge of CDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • NDA submission experience is a plus.

REQUIRED KNOWLEDGE AND ABILITIES:

  • Strong verbal and written communication skills are essential.
  • Excellent organization and multi-tasking skills.   
  • Ability to work independently and prioritize with minimal daily instruction.
  • Ability to think strategically in order to improve current processes.