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Senior Manager, Statistical Programming

Remote: 
Full Remote
Contract: 
Salary: 
224 - 258K yearly
Experience: 
Senior (5-10 years)
Work from: 
Massachusetts (USA), United States

Offer summary

Qualifications:

Bachelor’s degree in Statistics or related field, 6 years of related experience, Experience with clinical study results, Ability to create SDTM and ADAM datasets, Experience in regulatory submissions.

Key responsabilities:

  • Create programming plans and reports
  • Support regulatory submissions to FDA/EMA
  • Handle efficacy data and endpoints
  • Organize integrated summary of data
  • Provide programing for FDA committee meetings
Biolife Plasma Service logo
Biolife Plasma Service Pharmaceuticals Large https://www.biolifeplasma.com/
5001 - 10000 Employees
See more Biolife Plasma Service offers

Job description

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Your missions

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’s Privacy Notice and 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 Senior Manager, Statistical Programming in Lexington, MA with the following requirements: Bachelor’s degree in Statistics, Biostatistics or related field or foreign equivalent degree plus 6 years of related experience. Prior experience must include: Experience in Creating Programing plans, evaluation and reporting of clinical study results, in regulatory submissions to FDA and EMA agencies in different Therapeutic area; Programing experience in Clinical data standards, creating both SDTM and ADAM datasets following CDSIC guidelines; Experience in programing support for FDA meetings, Advisory committee meetings along with performing Ad-hoc requests for publications, posters, and other needs; Experience in handling and programing efficacy data including creating primary endpoints in different Therapeutic area; Experience in planning, organizing, handling, and programing integrated summary of safety and efficacy data from multiple studies including Phase 1-4. Up to 100% remote work allowed from anywhere in the U.S.

Full time. $224,000 - $258,000 per year.

Apply on-line at https://jobs.takeda.com and search for Req #R0134645.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Verbal Communication Skills
  • Analytical Thinking
  • Organizational Skills

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