Senior Statistical Programmer

Location
Emeryville, CA, United States
Posted
Oct 19, 2019
Ref
oPrg6fwm
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
PRIMARY PURPOSE OF POSITION:

This position is responsible for applying advanced programming techniques to support the development and validation of statistical programs to be used for monitoring, analyzing and reporting of clinical trials data for regulatory submissions and publications across multiple disease areas at Santen Inc.

MAJOR DUTIES OF POSITION:
  • Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
  • Applies advanced level programming techniques to the planning, implementation, and maintenance of software for the monitoring, reporting, and analysis of clinical trials
  • Participates in study statistical programming development and documentation to include the of data sets, tables, listings and graphs to meet project timelines
  • Serve as lead programmer to be responsible for the timeline and quality of all statistical analysis deliverables
  • Conducts program verification, identifies bugs and resolves technical problems
  • Uses creativity to solve complex programming problems
  • Works closely with Santen Inc. Biostatistics to create analysis files specifications and analysis outputs following the instructions provided in Statistical Analysis Plan (SAP)
  • Assists in the preparation and distribution of reports to the project team members
  • Works effectively with cross functional groups within Biometrics and the study team
  • Participates in monitoring CRO activities and reviewing CRO deliverables as necessary
  • Participates in the development of standard reporting tools for the statistical programming group
  • Contributes to developing Biometrics SOPs and guidelines
  • Contributes in the development, implementation and documentation of programming standards, templates and conventions, including potential implementation issues
  • Works with pre-clinical and clinical research staff to plan and query results for studies to support global development plans
  • Contributes to the implementation of CDISC standards for Santen studies
  • Serves as a Subject Matter Expert (SME) in Statistical Programming and mentors junior programmers
  • Serves as an expert troubleshooter

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum of 12+ years of SAS programming with 5+ years of Pharmaceutical clinical trial experience
  • MS in Statistics, Biostatistics, or Computer Science required. Ph.D. preferred.
  • Strong understanding of clinical trial data and extremely hands on in data manipulation, analysis and reporting of analysis
  • Advanced knowledge of Base SAS including data steps, PROC's, SAS MACRO and SAS GRAPH
  • Advanced knowledge of SAS/STAT or other statistical software
  • University level statistics course(s) or equivalent experience in statistics
  • Ability to interpret tabular and graphical clinical data presentations
  • Knowledge and application of p-values, confidence intervals, regression analysis, advanced general linear models including repeated measures models, survival analysis, non-parametric analysis, randomization, and proficiency in implementing these ideas in clear, efficient SAS code
  • Experience with EDC and some Clinical Data Management packages (Oracle Clinical or equivalent clinical EDM system) and relational database theory
  • Preferred experience working on FDA submissions
  • Preferred hands-on experience implementing SDTM and ADaM data standards
  • Able to give effective presentations to small groups such as project teams
  • Ability to effectively influence others
  • Ability to independently make high-level decisions
  • Strong cross-functional collaboration skills and ability to work with culturally diverse team members
  • Excellent verbal, written, organizational skills

List working relationships inside/outside of the organization other than your Direct Manager:
  • Biometrics staff members to including programming, statisticians and CDMs
  • Cross functional study team members
  • CRO programming staff membersPHYSICAL DEMANDS:The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to speak to a host of external individuals, domestically and globally; spend considerable time spent at computer; and be able to stand, kneel and stoop for filing, etc.