||September 04, 2020
||Private Sector BioStat Jobs
At Aural Analytics, we're developing the world’s most advanced suite of clinical-grade speech analytics for health applications, across the lifespan.
We’re looking for a biostatistician who will assist in guiding study designs and objectives, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, and writing up data analyses for the purpose of regulatory submissions, publications and/or other types of project reports.
- Collaborate with clients to provide guidance on experimental design and study objectives in a regulatory context, including power analyses
- Assist in writing study protocols and statistical analysis plans ensuring that appropriate regulatory requirements and study objectives defined in the study protocol are followed
- Select appropriate statistical approaches and conduct statistical analyses to meet client and/or regulatory requirements. Develop and/or review tables, listings, figures (TLF) and study reports.
- Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol
- Assist in performing analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
- Perform statistical QC of study data and final clinical study reports
- Contribute to the development of standard operating procedures for clinical trials
- Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
- Experience with creating study protocols and statistical analysis plans
- Experience with modeling time series data and complex endpoints
- Strong analytical skills, with the ability to process scientific and medical data
- Proficiency with R and SAS
- Ability to work independently
- Ability to identify data issues, present problems, and implement solutions.
- Excellent communication skills, with a demonstrated ability to convey technical concepts clearly, concisely, and understandably to colleagues of all backgrounds
- Good organizational and time management skills, with the ability to multi-task
- Familiarity with clinical trial design and analysis activities and strong knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Strong interpersonal communication and presentation skills
Education or Equivalent Experience:
- Masters or doctorate degree in biostatistics, statistics or other related, scientific field, and 5-7 years of relevant professional experience;
- or an equivalent combination of relevant education and/or experience.
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