Senior Manager, Statistical Programming - Full-time / Part-time

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Job DescriptionAbout the role:

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 to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Manager where you will be team-oriented and collaborative, with a strong understanding of the statistical programming function. Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet. As part of the Statistical Programming team, you will report to the Director and work with the Statistical Quantitative Sciences (SQS) organization.

How you will contribute:

• Aid in the preparation of high-quality regulatory submissions and preparing supporting documentation across the drug development lifecycle and Marketing Applications, under the direction of the Submission Excellence Lead for Statistical Quantitative Sciences (SQS).
• Work on ISS studies and contribute to the broader improvement of submissions (ad hoc regulatory work such, as 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 e.g. BIMO, and SDSP.
• Improve the efficiency of the 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 the automation team to architect macros for submission efficiencies.
• Apply technical knowledge and experience to deliver statistical programming deliverables to support study teams with limited supervision early in the role and independently later in the role.
• Ensure excellence in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible.
• Ensure adherence to high-quality programming standards.
• Occasionally attend submission working group meetings for high-visibility projects in the regulatory pipeline.
• Be 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 (e.g. FDA, PMDA, NMPA, EMA) pertaining to submitting clinical trial data to regulatory authorities.
• Working knowledge of CDISC SDTM, ADaM, Define.xml, and submission standards.
• Advanced knowledge of GCP/ICH standards and FDA requirements with prior experience filing an NDA/MAA/BLA.
• Ensure appropriate documentation and QC for all of their programming deliverables.
• Exhibit routine and occasionally complex problem-solving skills, seeking direction when appropriate.
• Experience with ICH and regulatory guidelines.
• Work 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:

• Bachelor's or Master's Degree in Statistics, Biological Sciences, IT, or related field.
• Equivalent combination of education and training in lieu of degree.
• Minimum of 8 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 is 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.

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 a 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.

Takeda SQS is open to flexible or remote working for some roles. Such roles will have a connection to a Takeda R&D center.

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

Base Salary Range: $130,200 to $186,000, based on the candidate's 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.

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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.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time