Principal Programmer
Pharmaron

Raleigh, North Carolina

Posted in Pharmaceuticals


This job has expired.

Job Info


Welcome to join our fast-growing team!

The Principal Statistical Programmer is responsible for providing leadership and hands-on support in the development and maintenance of the clients statistical programming capabilities which is required to meet regulatory obligations.

Pharmaron Clinical Services (PCS) located in Piscataway, New Jersey, is a full Contract Research Organization (CRO) dedicated to providing one-stop, high-quality clinical research and development services to our global partners. With a Staff of 3500, we provide full-service platforms in both China and the US. Our team is led by industry veterans with 15-25 years of experience.

Responsibilities:

  • Perform SAS data processes and analysis programming.
  • Works with Statistician and Statistical programmer to assure results are consistent with expectations, and Quality Control
    procedures are followed.
  • Lead the development and delivery of training.
  • Act as primary contact to ensure that company standards are implemented in all studies.
  • Works collaboratively to meet study deliverables and timelines for statistical data analysis and reporting.
  • Plans and carefully documents differences between programming results between program developer and Statistical QC
    programmer.
  • Provided programming support on ISS/ISE and post-submission activities.
  • Provide flexible and rapid response to programming requests.
  • Ensure consistency and adherence to standards within the project.
  • Confirms that tracking sheets are current for projects and confirm that results are consistent with earlier generated results.
  • Maintain up-to-date study documentation.
  • Identify opportunities to improve the methodology and provide practical solutions for problems.
  • Develop, program, test, and maintain computer validation/edit checks in SAS.
  • Validate peer programming.
  • Provide technical expertise and support to the Data Management team.
  • Routinely interface with cross-functional team members.
  • Participate in regular team meetings and provide input when appropriate.
  • Participate in the development of clinical programming SOPs and the development/optimization of clinical programming
    processes from study start-up to database lock.
  • Managing project priorities and timelines.
  • Have good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards, and protocol designs.
  • Review programming activities and costs in contracts.
  • Direct responsibility for supervising and training junior clinical programmers in the performance of their duties.
Qualifications:
  • BS degree or higher in programming or statistics.
  • SAS Experience in Pharmaceutical or equivalent: >=5 years, Oncology experience preferred.
  • Certified Base or Advanced SAS Programmer is a plus.
  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
  • Knowledge of CDISC standards and industry best practices.
  • Have good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards and protocol designs.
  • Strong SAS programming / Macros development / SAS graphs skills.
  • Excellent oral and written skills for cross-site and cross-function collaboration.
  • Dependable, motivated, focused, and detail orientated.
  • Ability to take direction as needed and work independently on project when necessary.
  • Capable of managing time effectively and adhering to timelines and project schedules Complementary Skills.
  • Working knowledge of SAS modules and utilities.
  • Ability to develop routines using the SAS Macro Language.
  • Understanding of biotech industry regulatory requirements.
  • Ability to use Microsoft Office tools: Word, Excel, PPT, etc.


This job has expired.

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