Director, Biostatistics

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Definium Therapeutics

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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

• Provide statistical input to the creation of clinical development plan for the assigned compound(s) • Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objective, endpoints and sample size • Play as an integral part of a protocol development team by authoring statistical methods section and reviewing the protocol throughout • Ensure the accuracy of randomization algorithm and contribute to eCRF design to ensure data collection’s alignment with study objectives • Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP • Hold the primary responsibility of working with statistical vendors to implement the SAP and deliver study results with quality and speed • Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis) • 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 Statistical Program group for validation • Contribute to the development of Biometrics’ SOPs

🎯 Anforderungen

• A PhD degree in Statistics or Biostatistics with at least 10 years’ working experience in pharmaceutical or biotechnology companies • Solid statistical knowledge and experience in clinical trial design from early to late phase, data analysis and reporting • Strong track record using statistical methods to solve real problems emerged in clinical trials and resulted in right decision-making and/or compound advancement • Rich experience is authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions of high quality • 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 interests of continued learning and growing • Detail-oriented and hold high standards of excellence for own 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!