Jobs
Meine Anzeigen
Meine Job-Alerts
Anmelden
Einen Job finden Tipps & Tricks Firmen
Suchen

Senior director, biostatistics, europe

Schwyz
Revolution Medicines
Inserat online seit: 10 Juni
Beschreibung

PpRevolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers. The company’s RD pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi‑selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C‑selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D‑selective inhibitor; and RMC-5127, a RAS(ON) G12V‑selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. /p h3The Opportunity /h3 ul liServe as the statistical lead for European access strategies, ensuring alignment between Global Clinical Development, European regulatory (EMA, MHRA, Swissmedic...) and regional/local Market Access needs to support successful European launches in collaboration with global and regional cross‑functional teams. /li liPartner with Regional and Local Market Access and HEOR functions to design and lead/oversee the execution of statistical analyses required for value dossiers, including PICO, indirect treatment comparisons, network meta‑analyses, and RWE generation. /li liPartner closely with the development statistical lead, provide statistical support for EU regulatory interactions, including EMA Scientific Advice, MAA, Type II variations, and post‑authorization commitments. /li liEnsure statistical methodologies align with EU guidance (ICH, EMA guidelines, CHMP expectations). /li liContribute to the global statistical strategy, ensuring study designs and endpoints satisfy both regulatory approval and reimbursement dossier standards in Europe, proactively addressing diverse data requirements for payers across different European jurisdictions. /li liProvide statistical expertise and support for regional study projects including study design, data analysis, and interpretation of results, to ensure high‑quality and scientifically sound outcomes. /li liCollaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately. /li liDrive and lead department initiatives, best practices, and guidelines. /li /ul h3Required Skills, Experience and Education /h3 ul liPh.D. or M.S. in Statistics/Biostatistics or related fields, a minimum of 10 years (for Ph.D.) and 15 years (for M.S.) of experience in the biotech/pharma industry as a statistician. /li liAbility to work independently and within a team. /li liSolid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials. /li liExcellent verbal and written communication skills are required. /li liGood interpersonal and project management skills is essential. /li liAdvanced methodological and technical skills. /li liStrong problem solving and critical thinking abilities. /li liProficiency in SAS and/or R. /li /ul h3Preferred Skills /h3 ul liStrong track record in submitting with EMA filing with proven experience in supporting HTA submissions (e.g. to GBA, HAS) as well as reimbursement dossier contributions in major European markets. /li liExperience in engaging with European scientific advice/early payer. /li liDeep understanding of evolving landscape of EMA, MHRA and Swissmedic, and the evolving landscape of joint clinical assessments (JCA) in Europe, in addition to European legislation requirements. /li liActive participation in NDA/BLA filing through label negotiations advantageous. /li liHands‑on experience in design and analysis of oncology trials. /li /ul /p #J-18808-Ljbffr

Bewerben
E-Mail Alert anlegen
Alert aktiviert
Speichern
Speichern
Ähnliche Jobs
Jobs Schwyz
Jobs Schwyz (Bezirk)
Jobs Schwyz (Kanton)
Home > Stellenanzeigen > Senior Director, Biostatistics, Europe

Jobijoba

  • Karriere & Bewerbung
  • Bewertungen Unternehmen

Stellenanzeigen finden

  • Stellenanzeigen nach Job-Titel
  • Stellenanzeigen nach Berufsfeld
  • Stellenanzeigen nach Firma
  • Stellenanzeigen nach Ort

Kontakt / Partner

  • Kontakt
  • Veröffentlichen Sie Ihre Angebote auf Jobijoba

Impressum - Allgemeine Nutzungsbedingungen - Datenschutzerklärung - Meine Cookies verwalten - Barrierefreiheit: Nicht konform

© 2026 Jobijoba - Alle Rechte vorbehalten

Bewerben
E-Mail Alert anlegen
Alert aktiviert
Speichern
Speichern