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.
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.
Work with Equip’s Data Science Team and Clinical Leadership to lead the end-to-end design of internal research projects.
Work with Equip’s Data Science Team and Clinical Leadership to meet Equip’s research mission and objectives by performing advanced statistical modeling and analysis.
Manage the lifecycle of IRB submissions and ensure all internal projects adhere to the highest ethical and regulatory standards.
Equip is the leading virtual, evidence-based eating disorder treatment program with a mission to ensure that everyone with an eating disorder can access treatment that works. Founded in 2019, Equip has been a fully virtual company since its inception and is proud of its highly-engaged, passionate, and diverse Equisters that have created Equip’s culture.
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.
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.
Design and execute analyses for analytical validation studies.
Perform relevant statistical analyses for studies of varying complexity.
Produce high quality presentations and author documentation.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. They aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions.
Directs the operational oversight and execution of clinical site start-up.
Manages CRO relationship and oversight to ensure appropriate scope of work.
Develops collaborative relationships with investigative sites.
Bristol Myers Squibb is focused on developing innovative drugs against targets of solid tumors. They are a dynamic biotechnology company headquartered in San Diego, CA, and aim to be the global leader in radiopharmaceuticals.
Develop, review, and update study-related training materials and documents.
Serve as Subject Matter Expert for clinical sites and provide guidance on protocol interpretation and eligibility requirements.
Partner with field Clinical Research Associates (CRAs) and CTAs to resolve issues identified during site visits.
ImmunityBio is a commercial-stage biotechnology company focused on developing cell and immunotherapy products designed to strengthen the immune system to eliminate cancerous or infected cells. They are publicly traded with headquarters in Southern California, working collaboratively to transform the lives of patients.