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Associate Director, Statistical Programming

Company: Takeda Pharmaceutical
Location: Newark
Posted on: January 24, 2023

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

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director where you will work on ISS studies and contribute to broader improvement of submissions (adhoc regulatory work such, BIMO, define) at Takeda and Build best practices and guidance documents around health authority submission-ready standards. You will also lead and organize programming activities for assigned clinical studies and projects As part of the Submission Excellence Programming team you will report to the Director or Senior Director, Programming and work closely with automation team to architect macros for submission efficiencies.

How you will contribute:

  • 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
  • Review documents for submission readiness and conformity to company and health authority guidelines e.g. BIMO, SDSP.
  • Improve 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.
  • 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 (e.g. 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.
    • 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. Minimum Requirements/Qualifications:
      • MS with 8+ years of industry-related experience.
      • BS with 10+ years of industry-related experience.
      • Proven track record of leading business process transformations and organizational culture change as well as driving programming expertise on programs with complex business deliverables
      • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
      • Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry. What Takeda can offer you:
        • Comprehensive Healthcare: Medical, Dental, and Vision
        • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
        • Health & Wellness programs including onsite flu shots and health screenings
        • Generous time off for vacation and the option to purchase additional vacation days
        • Community Outreach Programs and company match of charitable contributions
        • Family Planning Support
        • Flexible Work Paths
        • Tuition reimbursement More about us:

          At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

          This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

          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

          The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
          • In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Empowering our people to shine:

            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.

            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, Newark , Associate Director, Statistical Programming, Executive , Newark, New Jersey

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