p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'}p.p2 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px 'Helvetica Neue'; min-height: 14.0px}

THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 

POSITION SUMMARY:

Residing in our Boulder, CO office, the Senior Biostatistician will contribute key statistical expertise to our rapidly growing Companion Diagnostics program and will lead study design, data analysis, analysis validation, and oversee development of statistical analysis plans. This person will work closely with program technical leads, data scientists, and quality assurance personnel to think creatively and achieve ambitious goals to advance the treatment of cancer.

 

RESPONSIBILITIES:

· Design and analyze data from high-throughput sequencing studies, including analytical validation experiments and clinical studies aimed at advancing cancer therapies

· Lead study statistical design, sample size calculations, development of statistical analysis plans, data review, and task management

· Develop and execute statistical analysis plans in collaboration with contract CRO statisticians based on input from cross-functional study team

· Contribute to study reports and communicate results to scientists, quality assurance, and regulatory personnel

· Adhere to standard operating procedures and work in a manner compliant with regulatory standards

· Work closely with the director of biostatistics to 1) ensure adherence to timelines and quality standards across the unit and 2) advance statistical methodology and practice

· Serve as a mentor to junior biostatisticians and interns

 

QUALIFICATIONS:

· MS or PhD in Statistics, Biostatistics or related field

· 5+ years (PhD) or 10+ years (MS) of relevant industry experience including working as a biostatistician

· MS or PhD in statistics, biostatistics, or related field

· Expertise in analytical validation study design and analysis, specialize in statistical methods used to support products for regulatory submissions

· Understanding of molecular biology (experience with high-throughput sequencing preferred) 

· Proficiency with R programming (SAS considered)

· Excellent writing and communication skills

· Experience with data analysis in a regulated environment

· Ability to create visualizations that effectively communicate results

· Ability to meet goals in a fast-paced environment