Director, Biostatistics

 

About Aquinox:

Aquinox is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K pathway. Our lead product candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. In September, 2016, we began enrolling patients in a Phase 3 clinical trial in our lead indication, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).  Other indications are under consideration for future investigation. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. 

Aquinox is publically traded on NASDAQ and has offices in Vancouver, BC and in San Bruno, CA.

 

The Opportunity:

Reporting to the Vice President, Clinical Operations, the Director, Biostatistics will play a key role on our growing Clinical Development and AQX-1125 teams. This role will provide senior scientific, clinical trial design, strategic data analysis and interpretation.

 

This position may be located in our office in either Vancouver, BC, Canada or San Bruno, CA, USA.

 

The Director, Biostatistics will:

  • Provide senior statistical expertise for global clinical development
  • Provides key statistical interface with regulatory agencies in responses to relevant regulatory questions, and ensuring the generation of high-quality clinical trial data to aid in programmatic decision-making.
  • Provides a key statistical leadership role in the support of regulatory filings and submissions
  • Supports the development of clinical protocols based on sound research methodologies, available regulatory guidance or precedent, and appropriate endpoint and patient population selection.
  • Development of statistical plans
  • Develop or contribute to the Investigator’s Brochures
  • Provide statistical input to key study documents which may include CRFs, data management plans, monitoring plans, and safety plans
  • Perform ongoing review of study data including line listing reviews and blinded data reviews to assure highest scientific data quality
  • Ensure clinical database lock activities are completed to the highest quality
  • Provide in depth statistical review and interpretation of data leading to Clinical Study reports
  • Author and review statistical sections, as appropriate, of regulatory documents including INDs, annual reports, NDAs, briefing packages for Regulatory Authorities
  • Contribute statistical review and input for scientific publications and presentations
  • Provide statistical support collaboratively to other departments internally Clinical, Nonclinical/Preclinical, Technical Operations/CMC, Medical Affairs, Regulatory, Quality as requested
  • Ability to oversee and manage CRO biometric teams.

 

Experience:

  • Ph.D. in Biostatistics or closely related discipline with a minimum of 10 years of experience in pharmaceutical and biotech industry, or an MS in Biostatistics or equivalent with a minimum of 12 years of experience in pharmaceutical and biotech industry  
  • Previous experience with all phases of clinical research and New Drug Applications 

 

Education and other Requirements:

  • PhD in Biostatistics preferred
  • Experience in immunology, urology and/or gastroenterology desirable
  • Thorough knowledge of GCP and ICH Guidelines associated with clinical research and regulatory submissions (NDAs and/or BLAs, INDs), and other regulatory documents (CSRs, IBs and clinical study protocols) required
  • Demonstrated ability to develop complex statistical/clinical concepts
  • Demonstrated initiative and results orientation
  • Strong written and oral communication skills, and ability to communicate to a variety of scientific and non-scientific stakeholders
  • Ability to multitask and collaborate in a busy team-oriented work environment
  • Creative problem solver with the ability to address issues quickly independently, balanced with judgement to escalate issues as needed
  • Strong attention to detail and dedication to accurate and high-quality work
  • Able to travel ~ 15% of time (e.g. to Scientific Meetings, Investigator or Regulatory Meetings as necessary)
  • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to clinical trials – Phase 1 through 4.

 

Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity! We provide a collaborative and innovative environment with competitive incentive packages and rewards. Moreover, we provide the opportunity to partake in meaningful work.

Interested candidates are invited to forward their resume and cover letter to careers@aqxpharma.com, indicating why you feel you are a fit for the Director, Biostatistics role at Aquinox Pharmaceuticals, Inc.

We thank all applicants for their interest; only those chosen for an interview will be contacted.