BeOne Medicines · 3 days ago
Associate Director, Scientific Programming
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$152K/yr - $202K/yr
6+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking an Associate Director of Scientific Programming. The role involves leading statistical programming efforts for multiple development programs, ensuring deliverables meet industry standards and collaborating with various teams to support clinical trials and regulatory submissions.
Pharmaceuticals
Responsibilities
Collaborate with lead project Biostatistician in project strategic planning and provide overall guidance to the programming team in creation, implementation, and maintenance of programming development plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned; ensure that all programming has been carried out per industry and internal standard practice
Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines
Contribute to the development and implementation of programming resource algorithms
Collaborate with programming managers and project leads, lead the effort of project resource planning and tracking
Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables
Contribute to strategies for programming related matters in submission to regulatory agencies, publications and other communications as needed
Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities
Be a technical resource for programming groups to provide advice on complex programming tasks and/or standards
Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
Oversee the projects for the creation of analysis datasets, production / validation of output, and review of annotated case report forms
Lead the statistical programming support of FDA/EMEA/CDE regulatory submissions follow CDISC standards
Contribute to departmental process and standards initiatives such as tools and CDISC standards
Collaborate and support the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming
Oversee the work in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards
Lead the development of TAUG (therapeutic area users guide) following CDISC Industry standards
Other duties as assigned
Qualification
Required
Master's degree in a quantitative or scientific field (e.g., Computer Science, Statistics, Mathematics, Life Science) preferred with 6+ years of relevant experience
Experience with CDISC standards (SDTM, ADaM)
Familiarity with regulatory submission deliverables (e.g., TFLs, ISS/ISE, eCTD)
Knowledge of clinical data structures and study designs
Experience with ClinPharm/PK analyses
Familiarity with workflow automation and reproducibility
Ability to oversee multiple studies or programs
Vendor/CRO oversight experience
Cross-functional collaboration with Statistics, Clinical, Data Management, Clinical Pharmacology, Medical Writing, and Regulatory
SAS (Base, Macro, SQL)
R (data manipulation, analysis, visualization)
Python (scripting, data manipulation)
SQL / relational databases
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase