Associate Director, Biostatistics

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🕒 April 3

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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!