Biostatistics Associate Director, Biostatistics - Remote Texas
Orbis Clinical is seeking a remote-based Associate Director, Biostatistics until the end of the year.
Job Title: Associate Director, Biostatistics
Location: Remote
Contract: Until the end of the year
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
- 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
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $93.10 per hour, can vary depending on employment status.
- Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
