JobDescription:
Summary / purpose of theposition
The SeniorBiostatistician for Health Technology Assessments (HTA) is an IpsenGlobal Biometry biostatistician supporting the development of HTAin collaboration with Ipsen Health Economics and Outcomes Research(HEOR) and Global Value and Access teams.
He/Sheis responsible for the discussion and implementation of rigorousinformative and when appropriate innovative statistical models andanalysis methodologies that optimally address the researchobjectives. This position supports all Ipsen therapeuticareas.
He/She is responsible for designingimplementing and reporting in a quality timely and accurate mannerthe statistical processes in clinical trials applying state of theart concepts and tools to the interpretation of clinical trial dataso that the evaluation of such data will withstand interrogationand examination by payer bodies.
He/She overseesexternal vendors for outsourced activities and is responsible forthe corresponding deliverables (quality budget andtimelines).
Main responsibilities/ job expectations
Related to studyactivities
- Conductexploratory statistical analyses of Ipsen clinical trial data insupport of HTA objectives
- Contribute toauthoring of Global Value and Access deliverables (e.g. GlobalValue Dossiers Orphan Drug Designation submissions) and assist inevidence synthesis and economic modeling
- Provide expert statistical advice to address questionsfrom local country authorities in the reimbursement reviewprocess
- Provide statistical input forselection and evaluation of external vendors and takeresponsibility for ensuring that the Service Provider statisticaldeliverables meet project specifications and that they are producedto defined quality content and timetable standards and to liaisewith the Purchasing Manager to facilitate the achievement of timelyrelevant robust contracts and schedules of works.
- Plan schedule and track all statistical activities toensure high quality timely and accurate completion of statisticaldeliverables.
- Manage the Statistical input tothe reimbursement review process addressing payer questions in atimely technically sound and clearly presented manner.
- Develop Statistical processes within the Ipsen Group byworking with other statistician colleagues (i.e. Modelling andSimulation).
- Develop implement or advise onappropriate new statistical developments by keeping abreast ofcurrent issues and developments in statistical theory andapplication.
- Maintain a good network ofcontacts with outside bodies relevant to clinical statistics bothwithin the EU and North America.
- Any otheractivity which may be reasonably required from time totime.
- Complete all the above activities withinthe framework and in compliance with RD SOPs and otherdocumentation in force within the Ipsen.
Specifics ofPosition
- Ability tomanage projects: plan activities and tasks identify projectconstraints and dependencies identify and mitigate risks report onproject status produce progress metrics and communicate efficientlywith external vendors as well as internal partners
- Ability to produce high quality accurate work to meetdeadlines
- Ability to interact well with staffof differing disciplines
- Ability to mentorcolleagues in development of statistical thinking
- Welldeveloped time management communication presentationanalytical and interpersonal skills
- Responsible flexible and accountable with a proactiveapproach
- Expert knowledge and experience usingR and SAS and other statistical software
EHSresponsibilities
- Comply with applicable EHS regulations andprocedures.
- Participate in the sites EHSperformance by reporting risks malfunctions orimprovements
- Participate in mandatory EHStraining
Knowledgeabilities experience
Education /Certifications:
MS/PhD instatistics or biostatistics or related field
Experience:
Ideal: PhD with 4 years of experience in a similarposition. Good experience of participating in selection andmanagement of external vendors
Minimum: MS with7 years of experience as statistician in clinicalresearch
Key TechnicalCompetencies Required
- Advanced knowledge of Statistics and the drug developmentprocess applied to clinical studies
- Advancedunderstanding of statistical methods used in evidence synthesis(e.g. network metaanalysis indirect treatment comparisons) toclinical trial data
- High knowledge ofinternational standards (ICH GCP CDISC ) and regulatory submissionexperience (FDA EMA etc.)
- Proficiency withstatistical software tools such as SAS R SPlus EAST JMPC etc. Highlevel of expertise of oversight and management of externalvendors
- Strong attention to detail excellentcommunication skills good interpersonal skills and crossculturalunderstanding and sensitivity
- Ability to seethe big picture while keeping an eye on details
- Independent problemsolving and selfdirectionskills
- Ability to manage multiple complexprojects and assess resource needs
Lifelancer () is atalenthiring platform in Life Sciences Pharma and IT. The platformconnects talent with opportunities in pharma biotech healthsciences healthtech data science and ITdomains.
Please use the below Lifelancer linkfor job application and quickerresponse.
/jobs/view/30115cead6cc22217cd835e8a507ab88
RemoteWork :
No