Manager, Statistical Programmer
Lexington, Massachusetts- Job Level: Senior
- Travel: Minimal (if any)
Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics.
We nurture a culture that encourages disciplined risk-taking, supports innovation, values diversity and emphasizes implementation.
We want to hire and develop the best talent to join us on our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine!
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’sPrivacy Noticeand 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
Takeda Development Center Americas, Inc. is seeking a Manager, Statistical Programmer in Lexington, MA with the following requirements: Master’s degree in Math, Computer Science, or related field or foreign academic equivalent plus 6 years of related experience OR Bachelor’s degree in Math, Computer Science, or related field or foreign academic equivalent plus 8 years of related experience. Required skills: program analysis programs and quality control checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials; create standard macros that can be adapted to multiple studies; lead and organize study level programming and oversight activities for analysis of clinical trial data, ensuring quality and timeliness; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical analysis using various SAS procedures such as Freq, Univariate, Means, Logistic, GLM, Mixed, and Lifetest procedures. Company headquarters in Lexington, MA. Up to 100% telecommuting allowed from any location in the U.S.
Apply on-line at www.takedajobs.com and search for Req #R0118219.
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:
JOB LOCATION: Lexington, MA
POSITION: Manager, Statistical Programmer
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Manager, Statistical Programmer with the following duties: Lead study level programming and oversight activities ensuring quality and timelines; lead multiple studies, activities and parts of projects including studies or exploratory work related to clinical drug R&D; perform programmatic review/validation of analysis datasets and TLFs to ensure high quality of deliverables; program and perform thorough checks on SDTM Annotated CRF’s, Specifications, datasets along with Define.xml, Reviewer Guide, BIMO dataset and listings), P21 checks; create Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS); create TLFs to support submission Q&As in a quick turnaround, support, ad-hoc requests from (FDA, EU, PMDA) multiple agencies or potential Advisory Committee Meeting; create standard macros that can be adapted to multiple studies; own assigned tasks, identifies the need for and actively seeks input from others; engage cross functionally to progress tasks with proven influencing skills; contribute to process improvement initiatives; establish internal and external presence on topics of interest.
REQUIREMENTS: Master’s degree in Math, Computer Science, or related field or foreign academic equivalent plus 6 years of related experience OR Bachelor’s degree in Math, Computer Science, or related field or foreign academic equivalent plus 8 years of related experience. Required skills: program analysis programs and quality control checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials; create standard macros that can be adapted to multiple studies; lead and organize study level programming and oversight activities for analysis of clinical trial data, ensuring quality and timeliness; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical analysis using various SAS procedures such as Freq, Univariate, Means, Logistic, GLM, Mixed, and Lifetest procedures. Company headquarters in Lexington, MA. Up to 100% telecommuting allowed from any location in the U.S.
Full time. $130,200.00 - $223,200 per year. Competitive compensation and benefits.
Qualified applicants can apply at Takeda careers page at: https://www.takedajobs.com. Please reference job #R0118219. EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MAU.S. Base Salary Range:
Kristin Test
$133,000.00 - $228,000.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
Lexington, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeHow you'll shine
Many talents one goal
Our pipeline
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
Jobs for you
- Mo's Awesome Queen of the Land Boston, Massachusetts Category: Quality
- Senior Electronic Data Capture Engineer Boston, Massachusetts, Remote Category: Data Sciences
- Manager, Statistical Programmer Lexington, Massachusetts Category: Data Sciences
- Associate Director, Clinical Data Standards Cambridge, Massachusetts Category: Clinical Development
About our location
Join our talent community
Get customized job alerts sent right to your inbox. Plus, get the latest in company news and other important resources by signing up for our talent community.