Takeda Pharmaceutical Looking for Associate Manager Programming at Pennsylvania Full Time

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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.

• Contribute to the preparation of Electronic Submissions ( eSUB ) components ( reviewer’s guides, annotated CRF, define and XPTs ) with compliance to eSUB standards.

• 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.

• 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.

• Collate source documents about regulatory filings/submissions on request.

CORE ELEMENTS RELATED TO THIS ROLE

• W orking knowledge on CDISC SDTM, ADaM, Define.xml and submission standards.

• Ensures appropriate documentation and QC for all of their programming deliverables.

• Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.

• 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

• Basic understanding of the pharmaceutical industry and statistical programming (eg, clinical development, the prescription drug distribution process, etc)

• Strong general knowledge of technical and programming methods with some applied experience

• Asks good questions and applies educational training

Leadership

• Developing excellent communication 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

Decision-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 ited 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 accelerate 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 3 years experience in the Pharmaceutical Industry, or relevant Regulatory environment.

• Familiarity with pharmaceutical product/process development.

• 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.

Empowering Our People to Shine

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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.

Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time