Senior Statistical Programmer - San Diego, CA | Biospace
Get Our FREE Industry eNewsletter

Senior Statistical Programmer

Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
6/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biostatistics, Biotechnology, SAS,

Job Description

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.

Requirements

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 with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
• 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.