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Associate Director, Statistical Programming

Company: Takeda Pharmaceutical
Location: Rochester
Posted on: November 25, 2022

Job Description:

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda SQS is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles. Such roles will have a connection to a Takeda R&D center. ACCOUNTABILITIES

  • Under the direction of the Submission Excellence Lead for Statistical Quantitative Sciences (SQS), this specialized role within SQS will aid in the preparation of high- quality regulatory submissions and preparing supporting documentation across the drug development lifecycle and Marketing Applications.
  • This individual will also have an opportunity to work on ISS studies and contribute to broader improvement of submissions ( adhoc regulatory work such, BIMO, define ) at Takeda.
  • Build best practices and guidance documents around health authority submission -ready standards.
  • Review documents for submission readiness and conformity to company and health authority guidelines eg BIMO, SDSP.
  • I mprove the efficiency of submission reporting processes and improve the consistency, quality, and value of submission packages.
  • Provide education through guidance, subject matter expertise or consultation on electronic regulatory submissions by building submission -ready documents such as define, cSDRG, ADRG and performing a quality check and validating compiled submissions and finalizing the submission package.
  • Create and maintain submission templates and checklists.
  • Identify issues that may delay the completion of eSUB sections and escalate.
  • Work closely with automation team to architect macros for submission efficiencies .
  • A competent, hands on programmer who applies technical knowledge and experience to deliver statistical programming deliverables to support study teams with limited supervision early in role and independently later in role .
  • Actively engage as a member of industry standards organizations such as CDISC and PhUSE and work with industry experts to leverage and exchange knowledge and experience on regulations (eg FDA, PMDA) pertaining to the requirements for submitting clinical trial data to regulatory authorities.
  • Work closely with automation team to architect macros for submission efficiencies.
  • Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible.
  • Ensures adherence to high quality programming standards .
  • On occasion will attend submission working group meetings for high visibility projects in the regulatory pipeline.
  • An active promoter of talent, knowledge sharing, and collaborative spirit. CORE ELEMENTS RELATED TO THIS ROLE
    • CDISC and submissions experience.
    • Significant knowledge of regulatory requirements (eg FDA, PMDA, NMPA, EMA ) pertaining to submitting clinical trial data to regulatory authorities
    • W orking knowledge on CDISC SDTM, ADaM, Define.xml and submission standards
    • Advanced knowledge in GCP/ICH standards and FDA requirements with prior experience filing an NDA/MAA/BLA
    • Ensures appropriate documentation and QC for all of their programming deliverables
    • Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.
    • Extensive knowledge of drug submission requirements global regulatory submission
    • Good understanding of ICH and regulatory guidelines
    • Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.
    • May contribute to departmental innovation and process improvement projects. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
      • Working knowledge of current regulations, familiarity with eCTD format and content of regulatory filings Leadership
        • Developing excellent communicat ion to be able to convey both ideas and data, verbally and in writing
        • Uses education and internship experience knowledge for tasks
        • Completes assigned tasks under supervision Decis ion-making and Autonomy
          • Provide input into decisions that impact the technical components of programming
          • Responsible for completing assigned programming tasks within a study
          • Participate in initiatives to drive innovative solutions Interaction
            • Strives to understand the changing external and internal environment
            • Begin to build strong relationships and collaborate effectively with other interfacing Takeda functions, including but not lim i ted to statistics, data management, clinical operations Innovation
              • Comfortable challenging the status quo and bringing forward innovative solutions
              • Ability to recommend technical solutions using a wide variety of software ( eg SAS, R, Python)
              • Ability to communicate ideas around possible innovative solutions, and possibly ways to accelerat e existing milestones Complexity
                • Ability to work in a global ecosystem (internal and external)
                • Develop expertise required across statistical programming and computing environments
                • Develop awareness of best practices with data sharing
                • Develop awareness of programming input and standardization for novel data such as real world data, digital data, wearable device data EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
                  • Bachelor or Master Degree in Statistics, Biological Sciences, IT, or related field.
                  • Equivalent combination of education and training in lieu of degree
                  • Minimum of 12 years experience in the Pharmaceutical Industry, or relevant Regulatory environment.
                  • Familiarity with eCTD format and content of regulatory filings
                  • Proven leadership roles on small continuous improvement initiatives
                  • Experience in regulatory submissions throughout the development lifecycle
                  • Working knowledge of current regulations
                  • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language
                  • Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
                  • Working knowledge of clinical data and CDISC experience required
                  • Demonstrate skills in oral and written communications, managing and observing timelines
                  • Proven ability to operate with limited oversight
                  • Ability to effectively manage multiple tasks and projects Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Rochester , Associate Director, Statistical Programming, Executive , Rochester, New York

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