Senior Biostatistics Manager — Clinical Trials Lead

PTC Therapeutics, Inc.; New Jersey; On-site; USD 148,000 - 180,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Biostatistics to lead statistical design and analysis for clinical programs. You will define study designs, analyze data, and craft messages for internal and external stakeholders.

The role requires collaboration across functions, interaction with regulatory agencies, and adherence to SOPs, with 25% travel and a strong emphasis on timely, high-quality deliverables.

Qualifications

• PhD or MSc in statistics or related field with extensive pharma/CRO experience.
• Strong programming in SAS and/or R; statistical methodology and analysis plans.
• Experience interacting with regulatory agencies and preparing study reports.

Responsibilities

• Ensure timely, high-quality statistical deliverables for trials and analyses.
• Develop statistical analysis plans and study designs; review CRFs and data quality.
• Collaborate with cross-functional teams and regulatory bodies; manage vendor relationships.

Skills

Independent work

Analytical thinking

Time management

Regulatory knowledge

Education

PhD in Statistics

MS in Statistics

Tools

SAS

R

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Biostatistics to lead statistical design and analysis for clinical programs. You will define study designs, analyze data, and craft messages for internal and external stakeholders.

The role requires collaboration across functions, interaction with regulatory agencies, and adherence to SOPs, with 25% travel and a strong emphasis on timely, high-quality deliverables.