Senior Statistical Programmer (Early Phase)

Posted 28 March 2024
Salary Negotiable
LocationNorth Carolina
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameRobin Mantell

Job 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 +1 (786) 485 1298.