Sobi - Swedish Orphan Biovitrum AB (publ)

Principal Programmer

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $125,000 - $170,000 per year

Job Level

Lead

About the role

  • The Principal Programmer 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 being on the most expert in the field.
  • Drive and support company projects: Data and programming standards.
  • Enablement and finalization of regulatory submissions, regulatory response documents and other external clinical documents (e.g. publications) across multiple therapeutics area.
  • In-house database preparation and validation (e.g. Analysis datasets).
  • In-house preparation and validation of output (Table, Listing and Figure (TLFs)).
  • Pooling strategy for integrated analysis (pooling of data, ISE/ISS TLFs).
  • Preparation, review and finalization of regulatory document (e.g. Define.xml, Reviewer’s guide …).
  • Deep insight in CDISC standards.
  • Provide strong technical programming support to Data Management.
  • Prepare, support and enable corporate clinical meta-data, external clinical dictionaries (e.g. CDISC CT, MedDRA, and WHO DD) and corporate standard reporting systems: SAS macro utility programs and associated tools.
  • Support clinical studies with programming skills: Review study documents (e.g. protocol, CRF, SAP, and Clinical Study Report).
  • Take ownership and provide sponsor oversight of outsourced studies to CROs.

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 written and verbal Communication skills in English
  • Excellent knowledge of SAS programming and associated features and their applications in pharmaceuticals industry environment, in particular clinical trial data setting and clinical submissions (Base SAS, SAS Macro and SAS Graph)
  • Familiar with CDISC conventions, i.e. SDTM and ADaM models and related controlled terminologies, and knowledge or some experience using these models
  • Familiar with common external coding dictionaries (MedDRA and Standard MedDRA Queries, SMQ and WHO DD), knowledge or some experience of other external dictionaries (e.g. SNOMED, WHOART, COSTART and UNII)
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingBase SASSAS MacroSAS Graphstatistical programmingregulatory submissiondata validationclinical trial dataCDISC standardspooling strategy
Soft Skills
communication skillsmentoringsupportownershipoversight
Certifications
Bachelor of Science (BSc)