Manager, Statistical Programming

Location
Berkeley, California
Posted
Feb 28, 2018
Ref
17-066R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Supports all clinical trial statistical programming activities, including writing and reviewing specifications, developing SAS programs to create CDISC-conforming data tabulations and analysis datasets and generate statistical outputs such as tables, listings and figures, reviewing and validating programmed datasets as well as statistical outputs produced in-house or by contract research organization (CRO) products, and coordinating the work of other statistical programmers.

This position may provide technical and project oversight of contract programmers.

Responsibilities
  • Writes and documents development and validation programs to produce study data tabulation model (SDTM) data sets, analysis data sets (ADS), and statistical outputs/reports.
  • Tracks and documents program development/validation/production status.
  • Writes or reviews SDTM, ADS, and report specifications prepared internally or by CROs.
  • Designs, develops, and documents software systems and code libraries to improve efficiency and quality.
  • May supervise the work of other statistical programmers.
  • Reviews statistical analysis plans and other relevant documents.
  • Writes statistical programming standard operating procedures (SOPs) and work instructions.
  • Contributes to the development of plans and timelines for internal and CRO work.
  • Ensures compliance with SOPs, work instructions, ICH/GCP, and any other applicable local and international regulations.
  • Participates in internal/external audits and regulatory inspections as required.
  • Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.
Qualifications
  • BA/BS is required. MA or MSc in statistics/biostatistics or a related discipline is highly desirable. 
  • Strong SAS programming skills, including macros and statistical procedures.
  • Extensive experience in clinical trial statistical programming.
  • Has a thorough understanding of clinical trials design, endpoints and data process.
  • Knowledge of ICH/GCP.
  • Knowledge of CDISC SDTM and ADaM standards.
  • Ability to work on multiple projects simultaneously and adjust to changing priorities.
  • Excellent verbal and written communication skills and interpersonal skills.
  • Excellent organizational and project management skills and attention to detail.
  • Effective working within a cross-functional team and highly collaborative.