Associate Director, Statistical Programming

Location
Sunnyvale, CA
Posted
Apr 11, 2018
Ref
2352
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

General Position Summary/Purpose:

  • Responsible for the planning and tracking the Statistical Programming staff activities
  • Manage and coordinate the Statistical Programming staff to ensure efficient use of the resource and work flow
  • Build and enforce the appropriate standards in the department
  • Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Oversee and manage the work flow of generating study specific and ad-hoc clinical data listings, summary tables and figures.

Key Accountabilities/Core Job Responsibilities:

  • Manage Statistical Programming Department activities.
  • Oversees the work of direct reports 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, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Manage 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.
  • 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.

Qualifications:

  • Priority management/supervisory experience
  • 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 in multiple project.
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Solid knowledge of SAS Programming language.

Experience:

  • Minimum 15 years Pharmaceutical/Biotech programming experience with management experience.
  • Experience working with Oncology trials and NDA submission experience is highly desirable.
  • 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

  • MS or higher degree in Statistics, Math or Scientific Discipline.

#Li-SH23