Associate Director, Statistical Programming

Location
94080, South San Francisco
Posted
Jun 07, 2018
Ref
N18-037-24-03
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

ABOUT RIGEL:

Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.

POSITION SUMMARY:

The Associate Director of Statistical Programming is responsible for taking a lead role in the planning, tracking the statistical programming activities, managing, and coordinating resources to ensure efficient work flow.  The Associate Director of Statistical Programming responsibilities include building and enforcing the appropriate standards in the department and will design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Oversees the work on projects to ensure on-time, on-target and within-budget results
  • Acts as a liaison between statistical programming, data management, clinical operation, subcommittees and project teams as needed
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results
  • Acts independently to determine methods and procedures on new assignments
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data
  • Manage creating CDISC SDTM and ADaM files Creating SAS export files and Define.xml for Electronic Submission to FDA. Mange the activities of Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements
  • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection
  • Recognizes inconsistencies and initiates resolution of data problems
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles
  • Serve as external spokesperson for the organization as needed
  • Manage the developing of SAS coding and table templates for preparing, processing and analyzing clinical data 
  • Create/acquire tools to improve programming efficiency or quality
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports

KNOWLEDGE AND SKILL REQUIREMENTS

  • Ability to use professional concepts to achieve objectives in creative and effective ways
  • Experience in the analysis of complex clinical trial
  • Ability to manage multiple projects concurrently
  • Ability to use professional concepts to achieve objectives in creative and effective ways
  • Solid knowledge of SAS Programming language
  • Minimum 10 years Pharmaceutical/Biotech programming experience
  • Minimum 3 years of supervisory or lead management experience
  • Experience working with oNDA submission experience is highly desirable
  • Strong SAS programming and management background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
  • MS or higher degree in Statistics or other related discipline

 

Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity.

All individuals are encouraged to apply.