The Statistician will provide analytical support for internal and external scientific projects with a focus on the analysis and interpretation of NGS data. In addition, the individual in this position will be the analytical lead for multiple IVD submissions and apply their statistical knowledge to diagnostic analytical study design in support of 510k and PMA approvals.
Job performance will involve a variety of activities including:
- Selection of appropriate methodology and development of statistical analysis plans
- Provide statistical analysis including design of statistical models and programming (R, SAS, and other appropriate languages)
- Collation, management, and interpretation of data
- Analytical study design for 510k and PMA approvals
- Infrastructure development and advising senior management on data analytics requirements
- Interaction and communication both written and verbal to internal stakeholders, clients, and regulators
- Collaborate with cross functional team to achieve company objectives
- Conduct work in accordance with standard operating procedures, QA/QC policies, and applicable regulatory guidelines
- Create SAS and/or R programs to implement linear regression models, linear mixed models, generalized linear models, generalized linear mixed models, non-linear models, survival analysis, simulation studies (e.g. MCMC) and power/sample size estimation
- Generate tables, figures and listings (TFLs) for presentation and interpretation of results in accordance with project requirements
- Validation of statistical results and code generated by other team members
- Provide guidance to internal and external stakeholders on topics such as statistical methodology and programming, regulatory requirements and operational efficiency.
- Collaborate in research and clinical efforts
- Supervise outsource statistical resources to ensure work is completed to requirements
- Attend on site client visits, regulatory meetings, and scientific meetings as appropriate
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
- Proficiency in SAS or R programming is required; Proficiency in both is preferred
- Training in the theory and application of statistics.
- Experience in 510K/PMA diagnostic study design preferred but not required
- Statistical genetics and/or molecular assay validation experience required
- Experience with next generation sequencing data (DNA and RNA) is preferred
- Proven ability to work independently and in a team environment
- Excellent analytical and problem-solving skills
- Proficient in written and verbal communication
- Legally authorized for employment in the United States of America
- Ph.D. in Statistics or Biostatistics or equivalent experience
ArcherDX, the NGS applications company, is developing and commercializing a novel approach to target enrichment chemistry. Next-generation sequencing technology based on Anchored Multiplexed PCR (AMP™) generates a highly enriched library of gene targets of interest for downstream genomic sequencing. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.
Unless otherwise stated, all descriptions above are preferred but not required for our ideal candidate. Consideration will be given for comparable experience. ArcherDX is an Equal Opportunity Employer.
We offer competitive compensation and generous benefits programs. E-mail your résumé in confidence with salary requirements to email@example.com.
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