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Senior Manager, Statistical Programming

Company: BeiGene, Ltd. APAC
Location: Fulton
Posted on: June 12, 2021

Job Description:

BeiGene 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.

The Senior Manager, Statistical Programming will work in BeiGene's Statistical Programming group to manage and support Statistical Programming deliverables for multiple clinical studies.

Essential Duties & Responsibilities:

  • Technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed

  • Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines

  • Address resourcing to adequately staff projects as needed

  • 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

  • Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables

  • Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for 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 group to provide advice on complex programming tasks and/or standards.

  • Contribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documents

  • Interface with outsourcing partners and vendor

  • Other duties as assigned

Core Competencies, Knowledge and Skill Requirements:

  • Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADAM datasets (as needed)

  • Computer programming using SAS

  • 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

Requirements:

  • Expert level SAS programmer with experience in delivering on complex programming assignments and analysis

  • Expert level knowledge and extensive hands-on experience of CDISC methodologies

  • Experience leading or working with centralized teams for Statistical Programming

  • Experience in Oncology Trials

  • Experience in FDA/EMEA/CFDA trial and regulatory submissions

  • Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research

Education:

  • Master's degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience

Experience:

  • Minimum 7+ years' clinical research and development programming experience using SAS

Core Competencies:

Ethics - Treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational values.

Communication - Listens and gets clarification; responds well to questions; speaks clearly and persuasively in positive or negative situations; writes clearly and informatively; able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; supports everyone's efforts to succeed; contributes to building a positive team spirit; shares expertise with others.

Adaptability - Able to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and opportunities for development; pursues training and opportunities for growth; strives to continuously build knowledge and skills; shares expertise with others.

Dependability - Follows instructions and responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; completes projects on time and budget.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental 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.

Keywords: BeiGene, Ltd. APAC, Columbia , Senior Manager, Statistical Programming, Other , Fulton, Missouri

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