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

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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 +1 (786) 485 1298.