Senior Statistician

Tekgence Inc; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A leading company in the IT Services sector is seeking a Senior or Principal Statistician to leverage statistical expertise in optimizing clinical trials. The role involves managing projects, collaborating with experts, and ensuring data quality. Candidates should have a PhD in Statistics or Biostatistics and experience in the Pharma/Biotech industry, particularly with SAS. This is a remote position offering a contract employment type.

Qualifications

• 3+ years of experience in analyzing clinical trial data.
• Experience with drug development processes and regulatory submissions.
• Proficiency in SAS and understanding of CDISC standards.

Responsibilities

• Execute and manage synthetic control arm projects.
• Collaborate with various experts for data integration.
• Create and review clinical trial documents.

Skills

Statistical analysis

Clinical trial design

Communication skills

SAS

Data standardization

Education

PhD in Statistics or Biostatistics

Tools

SAS

Job description

Direct message the job poster from Tekgence Inc

IT Recruitment Manager | Talent Acquisition Leader in Tech | Client Relation | Connecting Top Tech Talent with Innovative Companies

Senior or Principal Statistician

Remote / EST

Please find the detailed Job Description (JD):

Senior or Principal Statistician

Your Mission:

• Leverage your statistical expertise and programming skills to execute, manage, and QC synthetic control arm (SCA) projects and develop innovative approaches to optimize clinical trials. An SCA is an external control created using appropriate statistical methods to achieve baseline balance and augment clinical trials with patient data from previous trials. Medidata has access to thousands of such trials in the Medidata Enterprise Data Store.
• Collaborate with data standardization experts, statistical programmers, biostatisticians, and other Medidata groups to support cross-trial data integration and assess data adequacy for research objectives.
• Create and review protocols, statistical analysis plans, and other clinical trial documents.
• Support and review specifications for ADaM datasets, guide statistical programmers, and perform QC on efficacy and safety data analyses using SAS.

Skills / Requirements:

• PhD in Statistics or Biostatistics; exceptional MS candidates may be considered.
• 3+ years of experience analyzing clinical trial data or managing QC in SAS within the Pharma/Biotech industry; additional programming skills are a plus.
• Strong skills in clinical trial design, analysis, and interpretation, especially in time-to-event, matching/weighting, or Bayesian methods.
• Experience with drug development processes, data standardization, and reporting.
• Knowledge of regulatory submissions, define.xml, FDA guidelines is advantageous.
• Proficiency in SAS, understanding of CDISC standards, and experience with Phase II/III Oncology trials are preferred.
• Excellent communication skills, ability to work under pressure, and multitask effectively.

Location: 6655 Deseo Dr, Suite 104, Irving, TX 75039 • www.tekgence.com

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Business Development, Healthcare, IT

Industries

• IT Services, Consulting, Banking

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