Senior Manager, Biostatistics

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Biostatistics to lead statistical support for clinical trials in Oncology. This pivotal role involves designing innovative studies, conducting advanced statistical analyses, and collaborating with cross-functional teams to achieve project objectives. The ideal candidate will possess a strong background in drug development, excellent communication skills, and a passion for pioneering statistical methods. Join a dynamic team dedicated to advancing clinical research and making impactful contributions to patient care. This is a unique opportunity to influence the future of oncology treatment and be part of a mission-driven organization.

Qualifications

• PhD with ~3 years experience or MS with ~6+ years experience required.
• Strong statistical programming skills in SAS and/or R are essential.

Responsibilities

• Design clinical trials and provide strategic inputs for data-driven decisions.
• Conduct advanced statistical analysis and ensure robust data analysis.

Skills

Knowledge of drug development

Clinical study design

Statistical programming skills (SAS and/or R)

Excellent oral and written communications skills

Strong collaborative skills

Project management skills

Innovative statistical methods

Complex modeling

FDA and ICH regulations knowledge

Inter-personal skills

Education

PhD in statistics/biostatistics

MS in statistics/biostatistics

Job description

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Job Description

About the role:
The Biostatistics, Senior Manager is responsible for providing statistical support for early and late phase clinical trials in the Oncology Therapeutic Area statistics group and timely delivery of statistical deliverables. This role contributes to Takeda's mission.

How you will contribute:

• Design clinical trials, provide strategic inputs and innovative solutions, and support the team to make data-driven quantitative decisions
• Conduct advanced statistical analysis and ensure robust and accurate data analysis through extensive knowledge in biostatistics
• Support the adoption of novel designs and innovative statistical methods
• Facilitate execution and delivery collaboration with cross-functional teams to achieve project objectives
• Lead and be accountable for study level delivery strategies being implemented with effective risk identification and mitigation

Skills and qualifications:

• Knowledge of drug development, clinical study design, trial simulations, analysis methodology and data interpretation.
• Innovative thinker, driving the adoption of novel design, innovative statistical methods and complex modeling.
• Knowledge of FDA and ICH regulations and industry standards applicable to study design, data analysis of clinical trials and regulatory submissions.
• Statistical leadership and support for quantitative decision making, regulatory meetings, and submissions.
• Strong collaborative skills and ability to effectively work with a cross-functional team to achieve project objectives.
• Strong statistical programming skills (SAS and/or R).
• Excellent oral and written communications skills.
• Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases. (Experience in Oncology preferred.)
• Strong inter-personal skills.
• Strong project management and time management skills.

EDUCATION:

Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials:

• PHD with ~ 3 years experience
• MS with ~ 6+ years experience

BEHAVIOURAL COMPETENCIES:

• Inspire teamwork
• Assess benefit risk of options
• Develop understanding of business beyond SQS
• Focuses on priorities

Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time