Associate Director, Biostatistics

2 weeks ago

Austin, United States Innova Solutions Full time

A client of Innova Solutions is immediately hiring for an Associate Director, Biostatistics.  Position type: Full-time– Contract   Duration: 3+ Months  Location: REMOTE  As Associate Director, Biostatistics, you will:  Job Description: 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.  Responsibilities:  1. Lead in indication/study level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective  2. 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  3. Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements  4. Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results  5. Contribute to developing standards and research in advanced statistical methodologies  6. Author/review regulatory documents or scientific publications  Requirements:  1. 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  2. Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction  3. Experienced as study lead statistician and contributing to strategy discussion in cross functional settings  4. Experienced in study level work including authoring SAP and TFL specification  5. Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance  6. Solid understanding of mathematical and statistical principles  7. Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies.  Thank you  Lailun Sheikh  Phone:   PAY RANGE AND BENEFITS:  Pay Range*: $75.00-$90.00 per hour.  *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.  Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and 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, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). 

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