Principal Programmer

Software EngineerSoftware EngineerFull TimeRemoteTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

35 days ago

Salary

$125K - $170K / year

Bachelor Degree10 yrs expEnglish

Job Description

• Provides communication skills and expertise in the preparation of regulatory, clinical, and marketing documents throughout drug development, post-marketing and life-cycle management. • Provides mentoring and support to individual members of the Statistical Programming Team. • Drive and support company projects: Data and programming standards • Enablement and finalization of regulatory submissions and other external clinical documents across multiple therapeutics area • In-house database preparation and validation

Job Requirements

  • Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.
  • A minimum of 10-years experience of Statistical programming in the biotechnology/pharmaceutical industry
  • Experience of regulatory submission with FDA or PMDA
  • Experience of regulatory submission with EMA
  • Excellent knowledge of SAS programming and associated features
  • Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies
  • Excellent oral and written communication skills
  • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results

Benefits

  • Competitive compensation for your work
  • Generous time off policy
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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