Manager Biostatistics

GQR; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

GQR is seeking a Senior Manager, Biostatistics, to lead statistical efforts for a leading biopharmaceutical organization. This remote role focuses on strategic input in study design, statistical analysis, and regulatory submissions, catering to candidates with significant experience in biostatistics within the clinical trials domain.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Paid maternity leave

Paid paternity leave

Qualifications

• 3+ years’ experience with PhD or 6+ years with MS.
• Expertise in clinical trial design and regulatory submissions.
• Strong programming skills in SAS and R.

Responsibilities

• Lead statistical tasks and guide study teams in clinical trial design.
• Develop and review statistical documents including SAPs and DMC charters.
• Contribute to protocol development and perform advanced statistical analysis.

Skills

Analytical skills

Communication

Programming in SAS

Programming in R

Education

PhD in Biostatistics/Statistics

MS in Biostatistics/Statistics

Job description

This range is provided by GQR. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

LinkedIn Top Voice | VP @ GQR | MIT AI/ML Certified Executive Recruiter | Built Teams for 100+ Biotech & Pharma Leaders | Getting You the Recognition…

Summary:

Our client, a leading biopharmaceutical organization, is seeking a Senior Manager, Biostatistics (Contractor) to lead statistical efforts across pivotal clinical studies. This role will involve strategic input into study design, statistical analysis, and regulatory submissions. It's a remote position based in Massachusetts, ideal for someone with advanced experience in biostatistics within the clinical trials space.

Responsibilities:

• Lead statistical tasks and guide study teams in clinical trial design and execution.
• Develop and review statistical documents including SAPs, DMC charters, and TFL specifications.
• Contribute to protocol development and regulatory filings.
• Perform advanced statistical analysis and develop novel methods where appropriate.
• Collaborate with cross-functional teams across biometrics, regulatory, and clinical functions.
• Review and contribute to regulatory documentation and scientific papers.

Requirements:

• PhD in Biostatistics/Statistics with 3+ years’ experience or MS with 6+ years.
• Expertise in clinical trial design, analysis, and reporting.
• Experience with regulatory submissions (NDA/BLA/MAA) and health authority interactions preferred.
• Strong programming skills in SAS and R; CDISC knowledge is a plus.
• Familiarity with ICH/FDA/EMA guidelines.
• Excellent analytical, communication, and time management skills.

Pay Rate:

$90.00/hour (W2 Contractor)

Full-time, 40 hrs/week

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Paid maternity leave

Paid paternity leave

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