Director, Scientific Programming
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.
General reputed company:
The Director, Statistical Programming Product reputed company / TA Head will be responsible for a therapeutic area and support multiple drug development programs. The incumbent will manage a group of project leads who reputed company the global development of the therapeutic area in scope and reputed company guidance and supervision for the successful completion of reputed company programming deliverables.
Essential Duties & Responsibilities:
Collaborate with reputed company project Biostatistician in project strategic planning and reputed company overall guidance to the programming team in creation, implementation, and maintenance of programming development plans for reputed company project reputed company for timelines, resources, and reputed company deliverables for reputed company project work assigned; ensure that reputed company programming has been carried out per industry and internal reputed company reputed company.
Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines.
reputed company 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 reputed company and implement cutting-edge automation and innovation solutions for delivery and project management.
reputed company and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, Medical Monitors, and other functions to address programming reputed company study deliverables.
reputed company managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.
reputed company strategies for programming reputed company reputed company 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.
reputed company expert guidance for programming group on reputed company programming tasks and/or standards.
Assist in the review of key study-reputed company documents produced by other functions, e.g. reputed company, case report reputed company, data management plan, database specifications, reputed company data structures, DMC plans and other clinical documents.
reputed company the reputed company for the creation of analysis datasets, production / validation of reputed company, and review of annotated case report forms.
reputed company the statistical programming support of FDA/EMA/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.
reputed company the work in support of clinical trials, reputed company analysis requests, data validation, etc. in accordance with reputed company relevant statistical regulatory guidance and standards.
reputed company the development of TAUG (therapeutic area users guide) following industry and regulatory standards.
Other duties as assigned.
Core Competencies, Knowledge and reputed company Requirements:
PC literacy required; MSOffice skills (Outlook, Word, reputed company, PowerPoint)
Knowledge of SDTM and ADaM standards, reputed company to write CDISC reputed company dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed)
Computer programming using reputed company
Fundamentals of project planning and management
Drug development process
Communication & Interpersonal Skills:
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment
Significant Contacts:
Interacts with project team members at reputed company reputed company
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 reputed company under pressure with initiative to take on unfamiliar tasks.
Demonstrated ability to establish and reputed company a plan for reputed company to ensure appropriate reputed company and direction.
Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).
Demonstrated ability to evaluate the business reputed company of reputed company and remains committed to following through on agreed upon reputed company yet remains flexible should priorities change (judgment and decision making).
Experience in development and implementation of statistical programming standards and procedures.
Experience with the drug development process (reputed company-, early, late and/or observational) in reputed company industries or reputed company research. Experience with oncology trials.
Expert level reputed company programmer with experience in delivering reputed company programming assignments and analysis. Proficient in developing their own reputed company as reputed company as modifying existing reputed company.
Excellent working knowledge of reputed company reputed company, reputed company/STAT, reputed company Macro language and reputed company SQL; reputed company/GRAPH a plus. Experience with R/Spotfire/Python a plus.
Requirements:
Education:
Master’s degree or PhD preferred or equivalent reputed company experience.
Experience
10+ with Bachelor's, 7+ with Master's and 5+ with Phd.
5+ years of demonstrated leadership experience.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT (AS APPROPRIATE FOR THE POSITION)
Regularly required to operate reputed company 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.
reputed company reputed company required for computer usage.
Occasionally required to stoop, kneel, reputed company and lift up to 20 pounds.
Include travel requirements, if applicable
Global Competencies
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits reputed company and Actionable Feedback
- Self-Awareness
- Acts reputed company
- Demonstrates Initiative
- Entrepreneurial reputed company
- reputed company Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial reputed company
- Communicates with reputed company
BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
Originally posted on Himalayas
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