Principal Programmer
Pharmaron

Job Info

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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.