Associate Director, Statistical Programming
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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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
- 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
- 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
- Ensures excellence in the programming of analysis ready
datasets, tables, listings, and figures for which they are
- 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
- W orking knowledge on CDISC SDTM, ADaM, Define.xml and
- 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
- Exhibits routine and occasionally complex problem solving
skills, seeking direction when appropriate.
- Extensive knowledge of drug submission requirements global
- 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
- 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
- Completes assigned tasks under supervision Decis ion-making and
- Provide input into decisions that impact the technical
components of programming
- Responsible for completing assigned programming tasks within a
- Participate in initiatives to drive innovative solutions
- Strives to understand the changing external and internal
- 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
- 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
- Ability to work in a global ecosystem (internal and
- Develop expertise required across statistical programming and
- 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
- Minimum of 12 years experience in the Pharmaceutical Industry,
or relevant Regulatory environment.
- Familiarity with eCTD format and content of regulatory
- Proven leadership roles on small continuous improvement
- Experience in regulatory submissions throughout the development
- 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
- 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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