Beigene

Beigene

Director, Scientific Programming

US-IN-Home Office · Director

Sponsorship not specified$182k-$242kDetected 6 days ago
PythonData StructuresSQLData AnalysisAccountingExcelSAPClinical TrialsFDA RegulatorySASLeadershipCommunicationProblem SolvingMentoringMicrosoft Office

About the role

  • Provides and Solicits Honest and Actionable Feedback

Responsibilities

  • Collaborate with lead project Biostati stician 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.
  • Lead or contribute to the development and implementation of programming resource algorithm.
  • Collaborate with managers, responsible and accountable for project resource planning and tracking.
  • Collaborate with intelligent solutions team to develop and implement cutting-edge automation and innovation solutions for delivery and project management.
  • Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.
  • Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities.
  • 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.
  • Lead the statistical programming support of FDA/EMA/CDE regulatory submissions follow 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.

Requirements

  • 10+ with Bachelor's, 7+ with Master's and 5+ with Phd.
  • 5+ years of demonstrated leadership experience.
  • Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
  • PC literacy required

Nice to have

  • Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.
  • Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).
  • Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research.
  • Experience with oncology trials.
  • Expert level SAS programmer with experience in delivering complex programming assignments and analysis.
  • Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL

Skills

  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment
  • Significant Contacts:
  • Interacts with project team members at all levels
  • Desired Background and Experience:
  • Experience leading teams supporting FDA/EMA/CDE filings.
  • Expert level knowledge and extensive hands-on experience of CDISC standards such as CDASH, SDTM, and ADaM
  • Experience leading or working with centralized teams for Statistical Programming
  • Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.
  • Experience in development and implementation of statistical programming standards and procedures.

Compensation

  • $181,900.00 - $241,900.00 annually BeOne 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.
  • 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.

Benefits

  • Close vision required for computer usage.
  • Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, Medical Monitors, and other functions to address programming related study deliverables.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
  • 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.

Company info

  • 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.

Equal opportunity

  • We are proud to be an equal opportunity employer.
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This listing is sourced directly from Beigene's careers page and normalized into a canonical job model.