Sobi - Swedish Orphan Biovitrum AB (publ)

rare strength

Principal Programmer

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

Location

Massachusetts

Posted

37 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