Assoc. Director, Statistical Programming Project Lead
BeiGene
Cambridge
5d ago

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.

Position Summary : The Associate Director, 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 Duties & 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 algorithm.

    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 group 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 Core Competencies, Knowledge and Skill Requirements : PC literacy required;
  • MSOffice skills (Outlook, Word, Excel, PowerPoint), SAS Knowledge of SDTM and ADaM standards, able to write CDSIC 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 DESIRED BACKGROUND AND EXPERIENCE (Include License or Certifications) Experience leading teams supporting FDA / EMEA / CDE filings.

    Solid knowledge and 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.

    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).

    Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions 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 (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.

  • Proficient in developing their own code as well as modifying existing code. Excellent working knowledge of Base SAS, SAS / STAT, SAS Macro language and SAS SQL;
  • SAS / GRAPH a plus. Experience with R / Spotfire / Python a plus. REQUIREMENTS Education : Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience Experience : 10+ years’ of directly related experience in biometrics (along with a M.

  • S.). 12+ years with a Bachelor’s, and 7+ with a PhD. 4+ years of demonstrated leadership experience Licenses or Certifications : N / A Competencies : Ethics - Treats people with respect;
  • Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Planning / Organizing - Prioritizes and plans work activities;
  • Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

    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 development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills;
  • Shares expertise with others. Dependability - Follows instructions, 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.

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