Manager, Statistical Programmer
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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 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: 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, MA
U.S. Base Salary Range:
Kristin Test
$133,000.00 - $228,000.00
The 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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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 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: 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, MA
U.S. Base Salary Range:
Kristin Test
$133,000.00 - $228,000.00
The 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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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