Job Description

COMPANY OVERVIEW

Founded in 2002, Intra-Cellular Therapies (ITI) is a biopharmaceutical company developing novel drugs, leveraging technology from the lab of Nobel laureate Dr. Paul Greengard, for the treatment of neuropsychiatric and neurodegenerative diseases.

Our mission is to develop innovative treatments to improve the lives of individuals suffering from neuropsychiatric and neurologic disorders, thereby reducing the burden on patients and their caregivers. Patient needs are the core of our efforts.

With headquarters located in the heart of NYC on the Alexandria Center for Life Science campus, we have access to some of the brightest scientific minds in the industry. This has enabled us to assemble a talented and passionate Research & Development team focused on finding innovative solutions for CNS and non-CNS diseases.

For more information please visit the Intra-Cellular Therapies, Inc. website at http://www.intracellulartherapies.com.

POSITION DESCRIPTION:

We are currently searching for Statistical Programmers at various levels in our Biostatistics department. The title offered (Manager, Director, etc.) will depend on the qualifications of the candidate. NYC Metropolitan area candidates who can eventually work in our NYC office are preferred.

You will be responsible for providing statistical programming support including technical guidance of statistical programming to clinical project teams as well as managing CROs, and implementing quality control process. You must have SAS Programing skills and be ready to assume the statistical programing support for studies in early and/or late-stage clinical development including analyzing data. This position is for a flexible, motivated, and pro-active candidate who can function successfully with some guidance.

RESPONSIBILITIES:

• Review statistical analysis plans and the corresponding analysis shells for tables, figures, and listings.
• Provide statistical programing support in SAS for Phase 1 to Phase 4 studies including regulatory filings
• Manage and coordinate CROs as required and perform quality control checks for SAS codes and outputs
• Review SDTM ADaM mapping specs, validates SDTM, ADaM datasets and TFLs
• Identify problems and develop global tools that increase the efficiency and capacity
• Maintain/archive medical database, SAS programs and results, and documentation
• Participate in technical meetings including internal and external representatives.
• Effectively develop SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PSUR, interim analysis.
• Assume responsibility 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
• Complete all company-based and job-related training as assigned by ITCI within the required timeline
• Additional duties as assigned by ITCI management

POSITION REQUIREMENTS:

• Master's or PhD Degree in statistics, biostatistics, or closely related field with minimum of 2 years of experience in pharmaceutical clinical trials.
• Experience writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials
• 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
• Demonstrating a high level of character and ethics; acts in line with a clear and visible set of values & beliefs
• Must be able to perform all essential functions of the position, with or without reasonable accommodation

Please send resume and cover letter for immediate consideration.

EOE

Company Description

Founded in 2002, Intra-Cellular Therapies (ITI) is a biopharmaceutical company developing novel drugs, leveraging technology from the lab of Nobel laureate Dr. Paul Greengard, for the treatment of neuropsychiatric and neurodegenerative diseases. Our mission is to develop innovative treatments to improve the lives of individuals suffering from neuropsychiatric and neurologic disorders, thereby reducing the burden on patients and their caregivers. Patient needs are the core of our efforts. With headquarters located in the heart of NYC on the Alexandria Center for Life Science campus, we have access to some of the brightest scientific minds in the industry. This has enabled us to assemble a talented and passionate Research & Development team focused on finding innovative solutions for CNS diseases. For more information please visit the Intra-Cellular Therapies, Inc. website at http://www.intracellulartherapies.com.