Associate Director, Biostatistics

Stelle nicht auf LinkedIn

🕒 vor 2 Monaten

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mails für Remote-Jobs erhalten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

Definium Therapeutics

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2019

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Definium Therapeutics ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das präzise psychedelisch-abgeleitete Therapeutika für psychiatrische und neuroentwicklungsbedingte Störungen entwickelt. Das Unternehmen konzentriert sich auf pharmazeutisch optimierte Formulierungen von Lysergid (LSD) und ein R-Enantiomer von MDMA, um Zustände wie schwere depressive Störung, generalisierte Angststörung und Kernsymptome von Autismus-Spektrum-Störung zu behandeln. Es treibt die Kandidaten mit einem wissenschaftlich fundierten, evidenzbasierten Ansatz durch präklinische und klinische Studien voran.

Beschreibung

• Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting • Serve as the biostatistician conducting integrated data analyses to support regulatory filing dossier preparation • Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objectives, endpoints and sample size • Author statistical methods section in the protocol and review the protocol throughout • Make certain the accuracy of randomization algorithm and contribute to eCRF design to ensure that study objectives, data analysis and data collection are aligned • Work with statistical vendors and internal Statistical Programming team to deliver study results or integrated analyses with quality and speed • Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication • Conduct data analyses as needed by using own SAS programs in collaboration with internal Statistical Programming team

🎯 Anforderungen

• A PhD degree in Statistics, Biostatistics or relevant fields with at least 7 years’ working experience, or a Master’s degree in Statistics, Biostatistics or relevant fields with at least 10 years’ working experience, in pharmaceutical or biotechnology companies • Solid statistical knowledge and experience in clinical trial design (early to late phase), data analysis, and reporting • Rich experience in authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions • Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed • Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis • Working knowledge of regulatory guidance relevant to clinical trials from design to analysis • Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals • Strong organizational and project management skills; demonstrated interest in continued learning and growing • Detail-oriented and hold high standards of excellence for their work products • Deliver and communicate effectively in the work-from-home environment • Excellent interpersonal skills and is a good team player

🏖️ Vorteile

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave and some fun fringe perks!