Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific with a strong focus on quality, professional development, and supportive culture.
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)
Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
Definium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint, searching for patient-centric, intelligent individuals.
Lead statistical strategy for hematology studies across phases of development.
Oversee generation and validation of TLFs and other statistical outputs.
Contribute to IND, NDA/BLA, and other global submissions.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets.
Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer using its expertise in chemistry. Nuvalent is an early-stage company bringing together experienced scientists and industry veterans with a proven track record in oncology drug development.