Manager, Statistical Programming, Statistical & Quantitative Sciences
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Job Description
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 Programming, Statistical & Quantitative Sciences
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Manager, Statistical Programming, Statistical & Quantitative Sciences with the following duties: Lead multiple studies, activities, and parts of projects including studies or exploratory work related to clinical drug R&D; lead study-level programming and oversight activities ensuring quality and timeliness such as (SDTM Annotated CRFs, SDTM/ADaM Specifications, and datasets along with Define.xml, Reviewer Guide), and P21 checks and TLFs); ensure high-quality deliverables; support submissions and Q&As in a quick turnaround, support, ad-hoc requests from (FDA, EU, PMDA) multiple agencies or potential Advisory Committee Meetings; recommend strategic decisions that impact the statistical programming function; participate in initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions; build strong relationships and collaborates effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, and medical directors. Up to 100% remote work allowed from anywhere in the U.S.
REQUIREMENTS: Bachelor's degree in Life Science, Computer Science, Bioinformatics, or related field plus 6 years of related experience. Required skills: Apply clinical SAS Programming Skills by utilizing SAS software (BASE, STAT, GRAPH, MACRO) to produce well-formatted datasets, tables, listings, figures, and outputs requested per programming specifications, Statistical Analysis Plan, and other study-related documentation; Utilize the knowledge of therapeutic indications (such as Oncology, CNS, Ophthalmology, etc) and different clinical phases and clinical trial processes to analyze and create/QC datasets/outputs as per regulatory requirements; Utilize knowledge of CDISC standards and eCRT package to do technical spec, aCRF annotation as per, and to write programs to create or QC SDTM datasets/ADaM datasets, create/review define.xml, and ADRG/SDRG); Lead clinical study-level programming to ensure quality and on-time delivery of the project; Recommend strategic decisions that impact the statistical programming function and write study-specific macros; Collaborate with cross-functional teams, including statisticians, safety teams, clinical operations, data managers, and clinical researchers.
Full time. $145,000 - $186,000 per year. Competitive compensation and benefits.
Qualified applicants can apply at Takeda careers page at: Please reference job #R0120978 . 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
149 100,00 $ - 255 600,00 $
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
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 Programming, Statistical & Quantitative Sciences
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Manager, Statistical Programming, Statistical & Quantitative Sciences with the following duties: Lead multiple studies, activities, and parts of projects including studies or exploratory work related to clinical drug R&D; lead study-level programming and oversight activities ensuring quality and timeliness such as (SDTM Annotated CRFs, SDTM/ADaM Specifications, and datasets along with Define.xml, Reviewer Guide), and P21 checks and TLFs); ensure high-quality deliverables; support submissions and Q&As in a quick turnaround, support, ad-hoc requests from (FDA, EU, PMDA) multiple agencies or potential Advisory Committee Meetings; recommend strategic decisions that impact the statistical programming function; participate in initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions; build strong relationships and collaborates effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, and medical directors. Up to 100% remote work allowed from anywhere in the U.S.
REQUIREMENTS: Bachelor's degree in Life Science, Computer Science, Bioinformatics, or related field plus 6 years of related experience. Required skills: Apply clinical SAS Programming Skills by utilizing SAS software (BASE, STAT, GRAPH, MACRO) to produce well-formatted datasets, tables, listings, figures, and outputs requested per programming specifications, Statistical Analysis Plan, and other study-related documentation; Utilize the knowledge of therapeutic indications (such as Oncology, CNS, Ophthalmology, etc) and different clinical phases and clinical trial processes to analyze and create/QC datasets/outputs as per regulatory requirements; Utilize knowledge of CDISC standards and eCRT package to do technical spec, aCRF annotation as per, and to write programs to create or QC SDTM datasets/ADaM datasets, create/review define.xml, and ADRG/SDRG); Lead clinical study-level programming to ensure quality and on-time delivery of the project; Recommend strategic decisions that impact the statistical programming function and write study-specific macros; Collaborate with cross-functional teams, including statisticians, safety teams, clinical operations, data managers, and clinical researchers.
Full time. $145,000 - $186,000 per year. Competitive compensation and benefits.
Qualified applicants can apply at Takeda careers page at: Please reference job #R0120978 . 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
149 100,00 $ - 255 600,00 $
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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