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TakedaPharmaceutical Nordics AB · 1 day ago

Senior Manager, Statistics

Boston, MA

Full-time

Onsite

Mid, Senior Level

$137K/yr - $215K/yr

3+ years exp

Takeda is a global, values-based, R&D-driven biopharmaceutical leader committed to delivering life-transforming treatments. The Senior Manager, Statistics will provide statistical support in clinical development within the Neuroscience Therapeutic Area, managing projects and leading data strategy development to optimize clinical trial designs.

Pharmaceuticals

Responsibilities

Lead and be accountable for study/program level delivery

Effectively drive and influence project teams towards seamless delivery while enabling and making decisions

Conduct advanced statistical analyses and perform trial simulations to provide innovative solutions and to optimize clinical trial designs

Implement a quantitative decision making framework to support data-driven decisions in clinical development

Participate in preparation of regulatory submissions and responses to regulatory agencies

Contribute to asset level strategies to identify and mitigate delivery risks

A Senior Manager, Statistics, through her/his daily work, should have impact on:

Global project sub-teams (e.g., Evidence Generation)

Broadly DQS functions

Parts R&D functions

Qualification

Statistical programming SASStatistical programming RAdvanced statistical analysesDrug development knowledgeFDAICH regulationsProject management skillsCollaborative skillsOral communicationWritten communicationDecision making

Required

Advanced knowledge of drug development, clinical study designs, trial simulations, analysis methodology and data interpretation

Advanced knowledge of pharmaceutical industry, overall drug development process and expertise in the cross-functional interfaces with the statistics function

Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions

Strong statistical programming skills (SAS and R)

Excellent oral and written communications skills

Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases

Strong project management skills

Strong collaborative skills and ability to work with a cross-functional team to achieve project objectives

PhD with approximately 3+ years of experience

MS with approximately 6+ years of experience

Be able to make decisions

Initiate and foster collaborative relationships