Sr. Statistical Programmer, Pharmacometrics

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POST DATE 8/31/2016
END DATE 10/26/2016

Regeneron Pharmaceuticals, Inc. Tarrytown, NY

Company
Regeneron Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360512
AJE Ref #
576029863
Location
Tarrytown, NY
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. br / br / Summary: br / These responsibilities of this position will be to: 1) Interact with BDM to generate STDM br / specifications and validate both SDTM and ADaM data sets 2) validate the SAS code per br / study SAP instructions, 3) validate the PK and PK/PD output files (TFLs). 4) Work with other br / members in the Pharmacometric function to generate exploratory (ad hoc) Tables and Figures. br / br / Responsibilities: br / This individual will provide SAS programing support, data set creation, validation and br / management within the clinical pharmacometric function. br / br / Working across functional areas with BDM and Clinical Pharmacology, support the creation of br / SAS code specification from the approved study SAP, and validation of SDTM data set. br / br / From SDTM data set this position will: /p ul dir="ltr" li Create and/or validate ADaM data sets /li li Create and/or validate NONMEM data sets /li /ul p br / Working in close association with Clinical Pharmacology generate exploratory post hoc Tables br / and Figures from raw data in LIMS and clinical study database /p ul dir="ltr" li Generate Study Tables, Figures, and Listings (TFLs): /li li Create TFL shell based on Study SAP /li li Populate TFL from SDTM and/or ADaM Data set /li li Validation and finalization of TFLs /li /ul p br / Additional responsibilities include: /p ul dir="ltr" li Maintain Pharmacometric SAS Network folder structure /li li Support the non-clinical CDISC/SEND data set initiative /li /ul p 1) Prior experience in successful regulatory NDA/BLA submissions. br / 2) Background in creating SDTM and ADaM data sets in SAS. br / 3) Well experienced in SDTM and ADaM data set validation. br / 4) Well experienced Generate and validate TLF. br / 5 Experienced in in generation and validation of NONMEM data sets br / for Pop PK and PK/PD. br / 6) Experienced in generation of high quality graph in SAS and/or R br / 7) Experienced in creation of exploratory PK and PK/PD data br / set from LIMS and clinical raw data sets. br / 8) Prior experience in support of Clinical Pharmacology, modeling & br / simulation, and other pharmacometric activities.