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Job Description

The Real World Data (RWD) team in the DQS Center of Excellence focuses on conversion of RWD sources into CDISC compliant SDTM and ADaM datasets for submission to health authorities.

Topic: RWD conversion programming (various sources) to CDISC to include data specs, programs, documentation and automation plans

As per FDA submission guidance for Industry, the structure of Real World Evidence (RWE) calls for clear, traceable to its source Real World Data (RWD), high quality data aligned with CDISC standards as closely as possible. The SDTM Trial Design Model provides a standardized way to format & describe the data submitted to Health Authorities. Currently RWD formats vary and do not match Clinical Trial data formats, content and structure. Review, restructuring and reformatting requires a manual process. This manual process is a time-consuming effort and is often completed on an as-needed basis.

Motivation:

Having consistency and accuracy in RWE domains development is very important for a successful submission. Based on the complexity of converting the RWD source to SDTM, sometimes the information still require manual review and discussion of interpretation or applicability, so comprehensive automation may not be possible. Standardizing and automating as much as possible will allow for hyper-focused review of that which cannot easily be categorized or mapped.

Objectives:

During the 12-week period, the intern will be guided and is expected to finish the action items below:

Familiarize self with CDISC standards and RWD formats (2 weeks): CDISC SDTM guidelines and core domain structures
Understanding Clinical Trials, data collection/use and submission standards
Familiarize with Takeda environment (SCE) for programming.
Familiarize mapping for RWD to SDTM.
Follow DQS CoE RWD team approach for mapping various sources RWD (1 week)
Create mapping specification for mapping various sources. (7 weeks)
Capture major specification differences between Flatiron RWD and new source. (1 week)
Deliver a presentation at the end of the internship. (1 weeks)

Impact:

The proposed effort would allow standardization of information that is captured by alternate RWD sources.
It would facilitate faster availability of RWE SDTM and subsequently ADaM and TLFs for RWE analyses, regardless of submission plans (i.e., it could make publication and exploratory work proceed faster).
Will reduce manual intervention and allow reduction of errors and inconsistencies arising out of manual approach.

References:

CDISC: Conformance Rules v1.1 for SDTMIG v3.2 and v3.3 CDISC: SDTM Metadata Submission Guidelines v2.0 CDISC SDTM Implementation Guide (Version 3.2) - Section 7 Trial Design Datasets

CDISC SDTM Implementation Guide (Version 3.2) - Section 7.5 How to Model the Design of a Clinical Trial

How You Will Contribute:

As an RWD Conversion Programming Intern, you will have the opportunity to…

Familiarize self with CDISC standards and RWD formats (2 weeks):
CDISC SDTM guidelines and core domain structures
Understanding Clinical Trials, data collection/use and submission standards
Familiarize with Takeda environment (SCE) for programming.
Familiarize mapping for RWD to SDTM.
Follow DQS CoE RWD team approach for mapping various sources RWD (1 week)
Create mapping specification for mapping various sources. (7 weeks)
Capture major specification differences between Flatiron RWD and new source. (1 week)
Deliver a presentation at the end of the internship. (1 weeks)

Internship Development Opportunities:

Become familiar with CDISC standards
Learn about different formats and sources of RWD
Learn about Health Authority submission requirements

Job Requirements:

This position will be Hybrid out of the Cambridge, MA location
Must be pursuing a Master’s Degree in life sciences, computer science, quantitative science, or data science related fields
Excel skills. Strong programming skills and algorithm development capability. Ability to create datasets and statistical analysis outputs using SAS and/or R.
The candidate is expected to consistently display good interpersonal skills, be able to successfully communicate well both verbally and in writing in a US business environment, be willing and able to accept and incorporate feedback, to take responsibility for planning their work and delivering agreed results, and be good at follow-through and completion of tasks. Initiative and an inquisitive nature are highly desirable.

Internship Eligibility

Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship

Must be currently enrolled in a degree program graduating December 2026 or later

The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)

The intern must be able to commit to one of these time frames

Able to work full time 40 hours a week during internship dates

Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program

Program Highlights:

Hands-on experience with real projects and responsibilities

Dedicated mentorship program pairing interns with experienced professionals

Networking opportunities with industry professionals and fellow interns

Internship events focused on professional and skills development

Exposure to multiple business areas or departments within a Pharmaceutical Organization

Applications will be accepted between October 31st- November 16th

Takeda Compensation and Benefits Summary

We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Cambridge, MA

U.S. Hourly Wage Range:

$21.00 - $46.00

The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. internship benefits vary by location and may include:

Paid sick time

Civic Duty paid time off

Participation at company volunteer events

Participation at company sponsored special events

Access to on-site fitness center (where available)

Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.

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

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Paid Intern (Fixed Term) (Trainee)

Time Type

Full time

Job Exempt

No

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