Senior Biostatistics Lead - Clinical Trials (Remote)

Innova Solutions Inc; Austin (TX); Remote; USD 103,000 - 124,000; Full time

Benefits offered by this job

Medical & pharmacy coverage

Dental/vision insurance

401(k)

HSA and FSA

Life Insurance

Pet Insurance

Disability insurance

Sick time

Paid leaves

Employee Assistance Program (EAP)

Job summary

Innova Solutions seeks an Associate Director of Biostatistics (remote) to lead statistical aspects of clinical studies, support regulatory submissions, and provide technical leadership across teams. The role demands a PhD in statistics or biostatistics and substantial post-graduate experience in pharma trials.

Responsibilities include study design, regulatory interactions, and advanced statistical methodology development. Strong SAS/R and CDISC SDTM/ADaM knowledge are required.

Qualifications

• PhD in Statistics or Biostatistics with post-graduate experience in clinical trials.
• Experience contributing to regulatory filings and interactions (NDA/BLA/MAA).
• Expertise in SAS and R with CDISC standards (SDTM/ADaM).

Responsibilities

• Lead indication/study level tasks including regulatory interactions and filing, ensuring statistical integrity.
• Contribute to study design, sample size, SAP and DMC charter; create review of CRFs and documents.
• Provide input on statistical methodology and regulatory data requirements for submissions.
• Develop standards and research in advanced statistical methods; author/regulatory documents.

Skills

Statistical leadership

Regulatory interactions

Study design

SAS

R

Education

PhD in Statistics or Biostatistics

Tools

CDISC SDTM

CDISC ADaM

Job description

Innova Solutions seeks an Associate Director of Biostatistics (remote) to lead statistical aspects of clinical studies, support regulatory submissions, and provide technical leadership across teams. The role demands a PhD in statistics or biostatistics and substantial post-graduate experience in pharma trials.

Responsibilities include study design, regulatory interactions, and advanced statistical methodology development. Strong SAS/R and CDISC SDTM/ADaM knowledge are required.