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.
These responsibilities of this position will be to: 1) Interact with BDM to generate STDM specifications and validate both SDTM and ADaM data sets 2) Validate the SAS code per study SAP instructions, 3) Validate the PK and PK/PD output files (TFLs). 4) Work with other members in the Pharmacometric function to generate exploratory (ad hoc) Tables and Figures. This individual will provide SAS programing support, data set creation, validation and management within the clinical pharmacometric function. Working across functional areas with BDM and Clinical Pharmacology, the incumbent will support the creation of SAS code specification from the approved study SAP, and validation of SDTM data set.
From SDTM data set this position will:
- Create and/or validate ADaM data sets
- Create and/or validate NONMEM data sets
Working in close association with Clinical Pharmacology generate exploratory post hoc Tables and Figures from raw data in LIMS and clinical study database
- Generate Study Tables, Figures, and Listings (TFLs):
- Create TFL shell based on Study SAP
- Populate TFL from SDTM and/or ADaM Data set
- Validation and finalization of TFLs
Additional responsibilities include:
- Maintain Pharmacometric SAS Network folder structure
- Support the non-clinical CDISC/SEND data set initiatives
- Bachelors degree +7 years experience or Masters degree +4 years experience
- Prior experience in successful regulatory NDA/BLA submissions.
- Background in creating SDTM and ADaM data sets in SAS.
- Well experienced in SDTM and ADaM data set validation.
- Well experienced Generate and validate TLF.
- Experienced in in generation and validation of NONMEM data sets for Pop PK and PK/PD.
- Experienced in generation of high quality graph in SAS and/or R
- Experienced in creation of exploratory PK and PK/PD data set from LIMS and clinical raw data sets.
- Prior experience in support of Clinical Pharmacology, modeling & simulation, and other pharmacometric activities.
- Proficient in SAS programming.
- Proficient in Excel/ and Excel macro generation.
- Basic understanding of WinNonLin and NONMEM is desirable.
- Basic understanding of biostatistics.
- Highly experienced in data file creation and management.
- Able to take directives and work independently.
- Excellent interpersonal skills.
- Manage multiple programs with competing and aggressive time lines.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.