Senior Statistical Programmer - Raleigh, United States - Mantell Associates

Description

Mantell Associates have the privilege of supporting a legacy CRO client who are expanding their Early Phase Statistical Programming division in the US.

Senior Statistical Programmer - Responsibilities:
Work on Phase I studies for the Early Phase Translation Medicine Group
Work with a variety of data including PKPD data
This is a small team so the correct programmer must be willing to wear multiple hats.


Senior Statistical Programmer - Requirements:
Ideal candidates will be problem solvers, confident, able to work autonomously right away
Hands-on experience in SDTM, ADaM and TLF programming with heavy emphasis in ADaM (strong understanding and hands on exposure with ADaM basics required)
Recent experience supporting early phase studies
Familiar with CDISC guidelines
Experience creating PK NCA files (ADPC, ADPP datasets, and TFL's), and CRT packages (ADaM datasets, define files, ADRG) within CDISC environment
Creating ADaM safety datasets (ADSL, ADLB, ADVS, ADEX, etc.) and specifications from scratch
Experience with NONMEM Dataset creation and analysis for PopPK, PopPD, PK Analysis, PD Analysis. (Required)
Experience with exposure response analysis
Exposure to cross over design and have supported pooling of PK parameters
Experience generating PC and PP datasets
Experience in CNS TA strongly preferred
5+ years' hands-on CDISC programming experience required

Please note, this is a remote opportunity, but the successful candidate must reside within the US or Canada.

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at

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