Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”

Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA®), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.

The position will be responsible for providing support and technical guidance of statistical programming to clinical project teams, and managing CROs, implementing quality control process. Individual must have solid SAS Programing skills and be ready to lead the statistical programing support for early and late-phase clinical development and medical affairs studies including analyzing data. This position is for a flexible, motivated, and pro-active candidate who can function successfully with a limited guidance. The candidate will report to the head of biostatistics.

Responsibilities:

• Responsible for reviewing the statistical analysis plans and the corresponding analysis shells for tables, figures, and listings.

• Manage and coordinate CROs as required and perform quality control checks for SAS codes and outputs.

• Reviews SDTM ADaM mapping specs, validates SDTM, ADaM datasets and TFLs Identifies problems and develops global tools that increase the efficiency and capacity.

• Responsible for maintaining/archiving medical database, SAS programs and results, and documentations. Participates in technical meetings including internal and external representatives.

• Effectively develops SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PSUR, interim analysis. Responsible for statistical datasets, data definition documents, tables, figures, and listings for regulatory submissions.

• Collaborate with data management to ensure high-quality preparation of study databases.

Requirements:

• Master's Degree in statistics, biostatistics, Computer Science, or closely related field with 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 submissions 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 the 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 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.

Manager/Sr. Manager, Statistical Programming: Base Salary Range $130,000 - $150,000

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