Senior Biostatistics Lead - Clinical Trials & Data Analysis

Alkermes; United States; Hybrid; USD 200,000 - 213,000; Full time

Job summary

Alkermes, headquartered in the United States, offers a hybrid work environment with 60% time in the office and 40% from home. The role is onsite at our Waltham, MA office at least 3 days per week and is not eligible for full remote work.

The incumbent will plan and execute biostatistical activities to support design and analyses of clinical studies and medical affairs tasks, including SAS/R analyses, protocols, SAPs, CSRs and manuscripts. Travel ~10% is expected.

Qualifications

• PhD in Biostatistics, Statistics or Applied Mathematics is required.
• At least 4 years of pharma/biotech/CRO experience.
• Experience with designing and analyzing Phase I-IV trials and regulatory submissions.

Responsibilities

• Plan and execute biostatistical analyses for clinical studies and medical affairs.
• Contribute to study protocols, SAPs, CSRs, and manuscripts.
• Possibly supervise CRO statistical planning and analyses and provide training.

Skills

Biostatistics leadership

R

SAS

SAS/STAT

SAS/GRAPH

Data analysis

Clinical trial statistics

Communication to non-scientists

CRO management

Study design and analysis

Education

PhD in Biostatistics

Statistics

Applied Mathematics

Tools

R

Base SAS

SAS/STAT

SAS/GRAPH

Job description

Alkermes, headquartered in the United States, offers a hybrid work environment with 60% time in the office and 40% from home. The role is onsite at our Waltham, MA office at least 3 days per week and is not eligible for full remote work.

The incumbent will plan and execute biostatistical activities to support design and analyses of clinical studies and medical affairs tasks, including SAS/R analyses, protocols, SAPs, CSRs and manuscripts. Travel ~10% is expected.