Job Description
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Senior Manager, Statistical Programming Project Lead will be responsible for a product area and support multiple indication development programs. The incumbent will lead the global development of the project in scope and provide guidance and supervision for the successful completion of all programming deliverables.
Essential Functions of the Job:
- 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
Supervisory Responsibilities:
- Not Applicable
Computer Skills:
- SAS (Base, Macro, SQL)
- R (data manipulation, analysis, visualization)
- Python (scripting, data manipulation)
- SQL / relational databases
Other Qualifications:
- Master’s degree in a quantitative or scientific field (e.g., Computer Science, Statistics, Mathematics, Life Science) preferred with 5+ 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
Travel: Minimum
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $144,400.00 - $189,400.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
Originally posted on Himalayas
