Associate Director, Statistical Programming

Location
South San Francisco, CA, United States
Posted
Aug 28, 2020
Ref
1995463529
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Statistical Programming

Position Overview:

The Associate Director, Statistical Programming will be responsible for statistical programming activities across multiple studies at indication level or compound level. This individual will play a key role for ensuring statistical programming datasets and outputs are delivered with high quality on time and within budget. This position will report to the Director, Statistical Programming.

Duties and Responsibilities:
  • Represent statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines
  • Collaborate with functional leadership to ensure adequate resources are allocated to meet the needs
  • Ensure statistical programming deliverables are delivered within the timelines agreed to
  • Review CDM documentation (such as CRF specification, data transfer agreements, data management plan, SDTM annotated CRF), Statistical Analysis Plan and TFL shell for consistency across the indication/compound, and provide statistical programming feedback
  • Ensure CRO statistical programming deliverables are accurate, complete, and compliant with CDISC standards by reviewing CRO deliverables and perform acceptance check and validation
  • Ensure consistency of statistical programming deliverables across indication/compound
  • Perform hands-on programming to generate TFLs to support publication and decision making
  • Create and maintain reusable macros at compound/indication level
  • Ensure adherence to company policies and relevant regulatory guidance
  • Assist in the development and maintenance of statistical programming policies, procedures, training and standards
  • Provide training and mentorship to junior statistical programmer

Qualification:
  • Bachelor's degree or advanced degree in statistics, computer science or other relevant scientific field. Master's degree preferred.
  • Minimum of 8 years of experience in statistical programming and analysis of clinical trial data in pharmaceutical/biotech industry
  • Minimum of 5 years of experience as lead statistical programmer
  • Experience of NDA/BLA submission preferred
  • Experience of CRO oversight preferred

Skills/Competencies:
  • Demonstrated proficiency and expertise in SAS programming for data analysis in clinical trials
  • In-depth knowledge of programing practices and concepts, and relevant regulatory guidelines
  • Extensive knowledge of CDISC standards and Pinnacle 21 validator
  • Demonstrated expertise in creating and reviewing ADaM specification
  • Broad knowledge in data collection, monitoring, cleaning and analysis throughout clinical development
  • Ability to apply programming knowledge and skills to problem solving for team
  • Ability to clearly communicate complex issues and articulate technical ideas to non-technical audiences
  • Ability to manage concurrent projects in a fast-paced environment
  • R programming skills, including R Markdown and R Shiny preferred


Principia Biopharma is an equal opportunity employer.