Associate Director, Statistical Programming

Remote

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 leadproductcandidate,lysergidetartrate(our proprietary orally disintegrating tablet form oflysergide(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 bythe recognitionthat patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to addresstheunderlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

As Associate Director, Statistical Programming, this role will provide statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization. Reporting to Director, Statistical Programming Lead, this role will serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed.

Working with the study lead biostatistician, this individual will oversee the deliverables from statistical vendors to ensure high quality and meeting timelines. Additionally, this role will perform statistical data analyses and partner with the Clinical Data Management group to support data cleaning activities.

Responsibilities:

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
• Review and ensure high quality of Define packages for integrated datasets from meeting CDISC standards to meeting regulatory requirements as part of electronic submission
• Work closely with study lead biostatistician to manage vendor’s deliverables from quality to timeline
• Perform independent validation (QC) to ensure accuracy of statistical vendor’s deliverables from datasets to analytic outputs
• Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
• Review CRF and/or Data Transfer Specification to ensure that data collection will meet the study objectives, requirements, and standards in CDISC format
• Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures
• Perform statistical analysis to support publications, and/or regulatory correspondence as needed
• Perform other duties as assigned

Qualifications and Skills:

• Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at…