Senior Scientist, Biostatistics, Clinical Safety Statistics

Scorpion Therapeutics; Rahway (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in Rahway, NJ, seeks a PhD-level statistician to provide statistical support for program-level evaluation of clinical safety data and collaborate with cross-functional safety teams across development stages.

You will design, develop, and evaluate safety evaluation methods and tools, perform ongoing aggregate analyses, and communicate results in oral and written reports using SAS and R to meet regulatory expectations.

Qualifications

• PhD in statistics/biostatistics or related field or Master’s plus 3+ years of relevant experience.
• Experience with survival analysis, meta-analysis, and Bayesian methods.
• Strong communication and cross-functional collaboration capabilities.

Responsibilities

• Provide statistical support for program-level evaluation of clinical safety data.
• Collaborate with cross-functional safety teams to plan and execute ongoing safety evaluations across development stages.
• Design, develop, and evaluate processes/tools for product safety evaluation, including ongoing aggregate safety evaluation at the program level.
• Collaborate with statisticians and statistical programming staff to deliver high-quality outputs meeting analysis requirements and regulatory expectations.
• Prepare oral/written reports communicating safety evaluation results.
• Assess need for novel statistical methodology and suitability of software.
• Conduct research on innovative statistical methods for clinical safety evaluation.

Skills

Study design & statistical analysis

SAS & R proficiency

Cross-functional collaboration

Attention to detail & multitasking

CDISC knowledge

Education

PhD in statistics/biostatistics or related field

Master’s + 3+ years relevant experience

Tools

SAS

R

Job description

Responsibilities:

• Provide statistical support for program-level evaluation of clinical safety data.
• Collaborate with cross-functional safety teams to plan and execute ongoing safety evaluations across pre- and post-marketing development stages.
• Design, develop, and evaluate processes/tools for product safety evaluation, including ongoing aggregate safety evaluation at the program level.

Primary Activities:

• Support strategic planning and scientific reasoning for safety evaluations.
• Plan and execute ongoing aggregate safety evaluations, including cumulative meta-analysis of safety.
• Design and apply safety evaluation methods, processes, standards, and tools (including enhanced graphical analyses).
• Collaborate with statisticians and statistical programming staff to deliver high-quality outputs meeting analysis requirements and regulatory expectations.
• Prepare oral/written reports communicating safety evaluation results.
• Assess need for novel statistical methodology and suitability of software.
• Conduct research on innovative statistical methods for clinical safety evaluation.

Education/Minimum Requirement:

• PhD (or equivalent) in statistics/biostatistics or related field, or Master’s plus 3+ years relevant experience.

Required Skills:

• Study design and statistical analysis knowledge (survival analysis, meta-analysis, Bayesian).
• SAS and R (R-Shiny a plus) for statistical/data processing.
• Strong oral/written communication and cross-functional collaboration.
• Initiative, attention to detail, high-quality execution, and ability to manage multiple priorities.

Preferred Skills:

• CDISC (SDTM, ADaM), observational epidemiology methods (confounding control), AI tools for writing/programming, regulatory knowledge for safety signal detection/evaluation/reporting, drug discovery/development and disease biology; interest in publication/research.