Remote Senior Manager Biostatistics – Contract

Innova Solutions Inc; Austin (TX); Remote; USD 103,000 - 110,000; Full time

Benefits offered by this job

Medical & pharmacy coverage

Dental & vision insurance

401(k)

HSA & FSA

Life Insurance

Pet Insurance

Disability coverage

Legal protection

Paid time off & leaves

Employee Assistance Program

Job summary

Innova Solutions is seeking a Senior Manager Biostatistics to lead statistical activities for clinical trials on a remote, full-time contract basis. The role focuses on study design, sample size determinations, and regulatory interactions, with responsibilities spanning protocol and SAP authoring, DMC charter work, and cross-functional collaboration.

The ideal candidate holds a PhD in Statistics or Biostatistics with at least 5 years in pharma, and is proficient in SAS/R with CDISC experience.

Qualifications

• PhD or equivalent with post-graduate experience in the clinical trials setting.
• Experience with NDA/BLA/MAA activities and regulatory interaction.
• Experience as study lead statistician and contributing to cross-functional strategy discussions.
• Experience authoring SAP and TFL specifications.
• Familiarity with ICH guidelines and FDA/EMA guidance.
• Solid mathematical and statistical foundations.
• Proficient in SAS and R; CDISC knowledge is a plus.

Responsibilities

• Contribute to study level tasks from statistics perspective, including design and sample size.
• Author/review statistics sections in protocols, SAPs, and DMC charters.
• Create/review study randomization files.
• Develop TFL shell and review CRFs and other study documents.
• Participate in study-related meetings and ensure deliverables' statistical integrity.
• Provide statistically sound input to meet project objectives and regulatory requirements.
• Independently conduct analyses as suggested by data.
• Propose novel statistical approaches to improve efficiency and sensitivity.
• Contribute to developing standards and research in advanced statistical methodologies.
• Author/review regulatory documents or scientific publications.

Skills

Study design

Sample size planning

Regulatory collaboration

Statistical analysis

SAS

R

CDISC SDTM/ADaM

Education

PhD in Statistics or Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Innova Solutions is seeking a Senior Manager Biostatistics to lead statistical activities for clinical trials on a remote, full-time contract basis. The role focuses on study design, sample size determinations, and regulatory interactions, with responsibilities spanning protocol and SAP authoring, DMC charter work, and cross-functional collaboration.

The ideal candidate holds a PhD in Statistics or Biostatistics with at least 5 years in pharma, and is proficient in SAS/R with CDISC experience.