Director, Statistical Programming

About Definium Therapeutics

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

Responsibilities

• 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

Qualifications and Skills

• 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