SunnyvaleRecruiter Since 2001
the smart solution for Sunnyvale jobs

Principal Statistical Analyst

Company: AbbVie
Location: Sunnyvale
Posted on: December 5, 2019

Job Description:

General Position Summary/Purpose: Provide programming support to produce analysis, reports and graphs on all PCYC drugs. Review program codes and suggest alternative solutions that may be efficient. Interact with GRAs, medical writers, clinicians, statisticians, data management and medical affairs personnel, and other members of PCYC R&D. Reports to the site Director, Biostatistics and Data Management and on a dotted line relationship to the Director of Statistical Computing. Key Accountabilities/Core Job Responsibilities:

  • Ensure technology updates occur as needed.
  • Provide programming support to analyze clinical data and generate reports and graphs on all PCYC drugs in the clinical phase.
  • Hire consultant programmers to meet short-term needs of additional programming resources.
  • Work with Director of Statistical Computing to establish and ensure adherence with programming and output standards and utilization of systems and processes to maximize efficiency of the statistical programming function.
  • Lead the development of new processes and provide accurate and timely responses to complex requests from clients and guide clients on possible options for deliverables for non-routine requests. Basic:
    • B.S., M.S. or Ph.D. in statistics, computer science, mathematics or a related field, required.
    • 7 years of experience in the pharmaceutical industry generating analysis , reports and graphs for individual studies and ISS, ISE, NDA submissions to FDA.
    • Minimum of 2 years of supervisory experience.
    • Excellent programming skills especially in SAS.
    • High degree of technical competency and strong communication ability, both oral and written.
    • Fluency in 2 or more or relevant programming languages, such as R, Python, Perl, Ruby, Java, or C++ required.
    • Competent in SAS programming and Macro development.
    • Excellent problem solving, leadership, communication and interpersonal skills
    • Working knowledge of current regulatory requirements and guidance.
    • Demonstrated ability to debug SAS programs and assist programmers.
    • Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience.
    • Thorough understanding of ICH Guidelines and relevant regulatory requirements.
    • Understand CDISC standards and applicability to clinical database design/capture and reporting.
    • Knowledge in integrating SAS with other leading technologies such as Extensible Markup Language (XML), Microsoft Office, etc. to support electronic submissions.
    • Knowledge of Pinnacle 21.
    • Understand about reviewer's guides and Define.xml. Education and Experience:
      • MS in Statistics, Computer Science, Bioinformatics, Biostatistics, or related field with 9+ years of relevant experience; OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.

Keywords: AbbVie, Sunnyvale , Principal Statistical Analyst, Professions , Sunnyvale, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Professions Jobs


Lyft Driver (No Experience Needed)
Description: What is Lyft Lyft matches drivers with passengers who request rides through the Lyft smartphone app. Signing up to be a Lyft driver is the perfect opportunity for you to set your own schedule and be (more...)
Company: Lyft
Location: San Rafael
Posted on: 12/16/2019

Parts Delivery
Description: br br Our Parts Delivery drivers provide excellent customer service through the safe and efficient delivery
Company: O'Reilly Auto Parts
Location: Tracy
Posted on: 12/16/2019

Office Associate Distribution Center
Description: Office Associate Distribution CenterApplyLocation:Tracy, CaliforniaWe at Crate and Barrel want to ensure we help our customers, love, how they live, in the moments that matter. At our Distribution Centers, (more...)
Company: Crate and Barrel
Location: Tracy
Posted on: 12/16/2019


Project Manager (Construction)
Description: MDE Electric is a major electrical contractor on large multi-family, mixed-use projects throughout the Bay Area. MDE is seeking an experienced project manager to join us in our Sunnyvale office. Purpose: (more...)
Company: MDE Electric Company
Location: Sunnyvale
Posted on: 12/16/2019

Tracy Team Truck Drivers: $24,000 Sign-On Bonus Per Team - Split!
Description: Apply Today br br TRACY TEAMS OR SOLOS THAT WANT TO TEAM br br Teams for Immediate Seating or we will find you a Team Partner br br 12K sign on bonus for each driver paid out 1,000.00 per (more...)
Company: US Xpress
Location: Ceres
Posted on: 12/16/2019

DevOps Architect
Description: DEVOPS ARCHITECT SUNNYVALE, CA ATLANTA, GA Here, you will have the opportunity to build the future of DevOps for some of the most innovative and successful organizations in the world, including Amazon, (more...)
Company: Comrise
Location: Sunnyvale
Posted on: 12/16/2019

Security Architect - Contract
Description: MUST WORK ONSITE IN SUNNYVALE, CA 6 MONTH CONTRACT, POTENTIAL TO GET EXTENDED US CITIZEN/GC
Company: Flashii App
Location: Sunnyvale
Posted on: 12/16/2019

Data Analyst
Description: This role will involve coding, analytical modeling, root cause analysis, investigation, debugging, testing and collaboration with the business partners, product managers ABOUT
Company: Sigmaways Inc
Location: Sunnyvale
Posted on: 12/16/2019

Business Process Analyst, SaaS (Contract)
Description: With a powerful combination of Digital Experience, Cloud Networking, and Cloud Edge solutions, Riverbed The Digital Performance Company provides a modern IT architecture for the digital enterprise, delivering (more...)
Company: Riverbed Technology, Inc.
Location: Sunnyvale
Posted on: 12/16/2019

Analyst, Tech Operations - Risk & Payments
Description: Intro: Facebook's mission is to give people the power to build community and bring the world closer together. Through our family of apps and services, we're building a different kind of company that connects (more...)
Company: Facebook
Location: Sunnyvale
Posted on: 12/16/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds