Director, Statistical Programming

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Definium Therapeutics

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51 - 200 Mitarbeiter

Gegründet 2019

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

Healthcare • 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

• Manage a group of statistical programmers to provide programming support for assigned projects from datasets creation (or validation) to data analysis • Join the regulatory filing team and serve as the lead statistical programmer to support integrated data analyses and ensure all data requirements are met for regulatory filing • Responsible for delivering high quality analysis datasets (SDTM and ADaM) from meeting CDISC standards to ensuring accuracy of all derived variables either for assigned clinical trials or for integrated databases • Responsible for delivering high quality integrated databases to support integrated safety and efficacy analyses • Responsible for high quality DEFINE packages for SDTM and ADaM either for assigned clinical trials or for integrated databases • Work closely with biostatisticians to manage vendor’s deliverables from quality to timeline • Perform statistical data analysis using own SAS programs as needed to support decision making, regulatory communication or drug product commercialization • Perform independent validation using own SAS programs to ensure accuracy of statistical vendor’s deliverables • Participate in developing necessary SOPs or processes governing statistical programing activities

🎯 Anforderungen

• Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 15 years of experience in using statistical programming to support clinical trial data analysis in pharmaceutical, biotech or CRO environment • Rich experience of building and leading statistical programming groups to deliver across programs often with competing priorities • Deep understanding about data standards with solid knowledge in creating DEFINE packages to support regulatory filing • Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED) • Extensive experience in managing statistical vendors to deliver with quality and speed and within the budget • Strong organizational skills, project and resources management skills • Detail-oriented and hold high standards of excellence for Statistical Programming group’s deliverables • Deliver and communicate effectively in the work-from-home environment • Strong track record of problem solving with demonstrated interests of continued learning and growing • Excellent interpersonal skills and is a good team player. • Preferred Experience: Experience in providing statistical programming support for CNS clinical trials • Experience in providing statistical programming support for regulatory filing.

🏖️ 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!