Associate Director, Biostatistics

Innova Solutions • Austin, NY

1d • Remote

About The Position

The Associate Director of Biostatistics acts as indication/study statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance.

Requirements

• PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
• Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction
• Experienced as study lead statistician and contributing to strategy discussion in cross functional settings
• Experienced in study level work including authoring SAP and TFL specification
• Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
• Solid understanding of mathematical and statistical principles
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies.

Responsibilities

• Lead in indication/study level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
• Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Contribute to developing standards and research in advanced statistical methodologies
• Author/review regulatory documents or scientific publications

Benefits

• Medical & pharmacy coverage
• Dental/vision insurance
• 401(k)
• Health saving account (HSA)
• Flexible spending account (FSA)
• Life Insurance
• Pet Insurance
• Short term and Long term Disability
• Accident & Critical illness coverage
• Pre-paid legal & ID theft protection
• Sick time
• other types of paid leaves (as required by law)
• Employee Assistance Program (EAP)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree