AbbVie Pharmacyclics Senior Manager, Statistical Programming in Sunnyvale, California

Senior Manager, Statistical Programming

Location: Sunnyvale, CA

# of Openings: 1

Description

General Position Summary/Purpose:

  • Manage and coordinate the Statistical Programming staff to ensure efficient use of the resource and work flow

  • Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.

Key Accountabilities/Core Job Responsibilities:

  • Manage Lower level personnel.

  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.

  • Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.

  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs usingBase SAS, SAS Macros, SAS/STAT, SAS/Graph,SAS/SQLand 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.

  • Acts as a liaison between statistical programming, subcommittees and project teams as needed.

  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.

  • May serve as external spokesperson for the organization.

  • Acts independently to determine methods and procedures on new assignments.

  • May provide guidance to other lower level personnel.

  • Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)

  • Develop 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.

Qualifications:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.

  • Experience in the analysis of complex Oncology clinical trial data.

  • Experienced in managing programming staff.

  • Solid knowledge of CDISC standard (SDTM & ADaM).

Experience:

  • Minimum 12 years Pharmaceutical/Biotech programming experience with minimum 3 years management experience.

  • NDA submission experience is a plus

  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.

Education Requirements (degree, certifications, etc.): Include must have and preferred

  • BS/MS in Statistics, MathorScientific Discipline.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled