Statistical Programming Lead

4 weeks ago


Bedminster, New Jersey, United States Intra-Cellular Therapies, Inc Full time

Intra-Cellular Therapies, Inc. is seeking a highly skilled Statistical Programming Lead to join our team. The successful candidate will be responsible for providing technical guidance and support to clinical project teams, managing CROs, and implementing quality control processes.

The ideal candidate will have a strong background in SAS programming, experience with CDISC SDTM and AdaM models, and the ability to work effectively with cross-functional teams. This is a fantastic opportunity for a motivated and proactive individual to take on a leadership role in our biostatistics department.

Key Responsibilities:

  • Review and implement statistical analysis plans and corresponding analysis shells for tables, figures, and listings.
  • Manage and coordinate CROs as required and perform quality control checks for SAS codes and outputs.
  • Validate SDTM, ADaM datasets, and TFLs, identifying problems and developing global tools to increase efficiency and capacity.
  • Maintain and archive medical databases, SAS programs, and results, and documentations.
  • Develop SAS programs for clinical study reports, regulatory submissions, and IB updates, DSUR, PSUR, and interim analysis.

Requirements:

  • Master's Degree in statistics, biostatistics, computer science, or a closely related field with a minimum of 3 years of experience (for Manager) and 7 years of experience (for Sr. Manager) in pharmaceutical clinical trials.
  • Experience writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials.
  • Experience with creating all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE.
  • Experience with SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language.
  • Experience with CDISC SDTM and AdaM models and transforming raw data into these standards.
  • Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry.

Intra-Cellular Therapies, Inc. is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability, or any other legally protected status.



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