Lead Statistical Programming Manager

2 weeks ago


Lexington, Kentucky, United States Takeda Pharmaceutical Company Ltd Full time


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Position Overview
Takeda Pharmaceutical Company Ltd.

is looking for a Lead Statistical Programming Manager with expertise in Lexington, MA. The ideal candidate will possess:
- A Master's degree in Mathematics, Computer Science, or a related discipline, or a foreign equivalent, accompanied by 6 years of relevant experience; OR
- A Bachelor's degree in Mathematics, Computer Science, or a related discipline, or a foreign equivalent, with 8 years of relevant experience.

Essential Qualifications:
- Conduct program analysis and implement quality control measures for analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials.
- Develop standard macros that can be utilized across various studies.
- Lead and coordinate study-level programming and oversight activities for the analysis of clinical trial data, ensuring both quality and timeliness.
- Prepare deliverables for regulatory submissions to agencies such as FDA, EMA, PMDA, and others (e.g., eCRTs, ISS, ISE, BIMO, P21 checks) and provide assistance for regulatory inquiries.
- Execute statistical analyses utilizing various SAS procedures including Freq, Univariate, Means, Logistic, GLM, Mixed, and Lifetest procedures.

Company headquarters are located in Lexington, MA, with the option for up to 100% telecommuting available from any location within the U.S.

This is a full-time position with a salary range of $145,000 to $223,200 per year.

Work EnvironmentEmployee
Employment TypeRegular
ScheduleFull time

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