Biostatistician

Company Overview

Auxogyn is a privately held company and leader in reproductive health. We provide novel scientific and clinically validated solutions to IVF clinicians and their patients by translating scientific discoveries in early embryo development into clinical tools that improve patient outcome. The company’s flagship product, the Eeva Test, delivers objective information regarding embryo development that IVF clinicians and patients can use to make important treatment decisions.

Auxogyn’s Eeva System is the first and only non-invasive device FDA has cleared to date to aid in embryo selection. Auxogyn received FDA clearance for the Eeva System in June, 2014. The Eeva System also received the CE mark in July 2012, and it is currently available for use in selected countries in the EU and Canada.

Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech. Follow the company on Twitter @Auxogyn.

Position Summary

As a member of Auxogyn Clinical Research Team, this position is responsible for developing statistical methods and data analysis procedures to analyze large registry, clinical trial and observational study data. This position is the key liaison with internal team in generating analysis and reports to various teams through data management, data scrubbing, statistical analysis, data mining, and report writing. This position will have a moderate amount of interaction with clinical study leadership, data management support teams, and research teams.

Major Duties and Responsibilities

  • Demonstrate a thorough understanding of statistical concepts and methodologies.
  • Perform complex statistical data analysis independently including but not limit to ANOVA, regression, generalized linear models, multivariate analysis, intra-and inter class variability.
  • Provide statistical input into protocol and case report form (CRF) development for clinical studies (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data).
  • Participate in the preparation of written reports that summarize the analysis of data, interpret the findings and provide conclusions and recommendations.
  • Develop, modify, and maintain computer programs which effect automated management of large sets of data.
  • Working with data sources to model trends and, relating those trends to changes in outcomes in the population.
  • Assure data accuracy and completeness in operational work, reports, files and databases.

Preferred Qualifications

Qualifications, Skills & Experience

  • MS in Statistics, Biostatistics, or related field with applied statistics training relevant to clinical trials and/or Medical Device research.
  • Minimum of five (5) years Medical Device or related industry experience for statistical support.
  • Ability to clearly describe advanced statistical techniques and interpret results.
  • Experience collaborating with non-statisticians to design, analyze and interpret data.
  • Proficiency with SAS statistical software.
  • Ability to manage multiple projects in a fast paced environment.
  • Possess excellent communication skills (oral and written.) Strong analytical and problem solving skills
  • Ability to meet deadlines and produce high quality deliverables.
  • Experience working in clinical data management applications (e.g. Oracle Clinical, Clindex, Datafax, Medidata, Rave) and report tools.
  • Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
  • Submissions experience a plus.
  • Experience working with relational databases a plus.

Special Skills, Abilities, and Requirements

  • Expert knowledge of good data management and good documentation practices
  • Strong knowledge of FDA 21 CFR Part 11 Regulation
  • In-depth knowledge of Health Insurance Portability and Accountability Act

Demonstrated Personal Characteristics

Candidate must be driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others. Essential attributes of the successful candidate is one who:

  • Is Action Oriented:
    • Motivated by results
    • Full of energy when faced with challenges
    • Able to make and implement tough decisions
    • “Proactive” as opposed to “reactive”
  • Deals with Ambiguity:
    • Can be flexible and adaptable in a complex, changing environment
    • Can comfortably handle risk and uncertainty
  • Works Collaboratively:
    • Practices attentive and active listening
    • Has the patience to hear people out and to search for constructive input
  • Exemplifies Interpersonal Savvy and Integrity:
    • Relates well to all kinds of people—both inside and outside the company
    • Builds constructive and effective relationships
    • Uses diplomacy and tact
    • Adheres to an appropriate set of core values and beliefs
    • Always acts with uncompromising integrity
  • Makes Quality Decisions:
    • Makes good decisions based on a mixture of analysis, wisdom, experience, and judgment
    • Seeks and encourages diverse input
    • Can challenge the status quo and think outside the box
    • Is sought out by others for advice and solutions
  • Is Respected as a Leader:
    • Leads and influences constituents with possible divergent interests to complete a common goal
    • Is recognized within the biostatistical community or related industry peers

We offer a competitive compensation package including health insurance, stock options and a challenging work environment. We are an equal opportunity employer.

Qualified candidates please send your resume to [email protected].

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