Sign upLog in

Associate Director, Biostatistics

The Steely Group

Remote, IL(remote)

Apply
JOB DETAILS
SKILLS
Analysis Skills, Biometrics, Biostatistics, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data Interchange Standards Consortium (CDISC), Clinical Trial, Cross-Functional, Data Analysis, Data Quality, Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, ICH Regulations, Marketing Authorization Application (MAA), Mathematics, Multitasking, Problem Solving Skills, Quality Assurance, R Programming Language, Regulations, Regulatory Submissions, SAP, Sample Design, Scientific Method, Scientific Publications, Standards Development, Statistics, Technical Leadership, Technical Support, Unix Shell Programming, Writing Skills
LOCATION
Remote, IL
POSTED
22 days ago

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:
  • 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
  • Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
  • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
  •  Independently conduct analyses suggested by the data; 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

Requirements / Qualifications:
  • 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
  • Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline
  • Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

About the Company

T

The Steely Group

Resume Resources

Free Resume TemplatesFree Resume Builder