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Stats Programmer
Posted on 6/7/2022
INACTIVE
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
R
SAP
Requirements
  • Attention to detail, ability to be self-driven and solid organization skills
  • Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Statistical Programming
  • Experiences with programing and reporting common statistical methods for clinical studies
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
  • Ability to successfully work together with a (virtual) team (including international teams as required) as well as independently
  • Excellent analytical skills
  • Effective time management in order to meet daily metrics or team objectives
  • A master's degree in a science discipline with at least 5 years' experience or a bachelor's degree in a science discipline with at least 10 years' experience
Responsibilities
  • Leading or overseeing, and where applicable performing, end to end statistical programing activities from study start-up to clinical study report
  • Interacting with inhouse clinical operation staffs, clinical data mangers, statisticians, and other clinical team members in study team activities
  • Leading interactions with CROs and third-party vendors (e.g. clinical laboratories) on statistical programming activities. Ensuring on time and quality deliveries of SAP, TFLs, SDTM and ADaM from CROs or vendors
  • Leading or overseeing the development of SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
  • Leading or overseeing the development of complex specifications for SDTMs and ADaM datasets
  • Leading or overseeing the development of SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
  • Reviewing CRO deliverables including Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Reviewing SDTM and ADaM specifications
  • Reviewing study randomization plan
  • Reviewing SAPs and TFL shells from a programming perspective for studies and leading the development of complex TFL shells from a programming perspective
  • Providing programing support for publications or presentations in clinical studies or regulatory sciences
  • Developing and maintaining standard operating procedures (SOPs), work instructions and training guides etc
  • Assisting in on-boarding, or mentoring new team members, including on-site consultants
Desired Qualifications
  • Proficiency in SAS. R-language is a plus
JUUL Labs

1,001-5,000 employees

Smoking alternative
Company Overview
JUUL Labs' mission is to transition the world's billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products.
Benefits
  • A place to grow your career. We’ll help you set big goals - and exceed them
  • People. Work with talented, committed and supportive teammates
  • Equity and performance bonuses. Every employee is a stakeholder in our success
  • Boundless snacks and drinks
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • Excellent medical, dental and vision benefits
Company Values
  • Earn trust
  • Better together
  • Embrace the challenge
  • Lead with empathy
  • Enjoy the journey