Career Opportunity – Director, Biostatistics
Aquinox Pharmaceuticals, Inc. (AQXP) is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Aquinox has successfully completed multiple preclinical studies and clinical trials with AQX-1125 and is advancing through Phase 2 development. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
We are looking for an experienced, hands-on, Director, Biostatistics to complement our clinical operations team. This is an exciting time to join our team and help contribute to the analysis of data from current and planned clinical trials.
Reporting to the Senior Director, Clinical Development, the Director, Biostatistics will be responsible for providing expert strategic and tactical guidance for statistical and database deliverables for our studies. As the statistical lead for the Company, the Director, Biostatistics establishes and communicates the statistical requirements and impact of planned and completed projects to stakeholders, to ensure clinical studies are developed and completed in a manner that supports statistical analyses. This role also has the responsibility for sponsor oversight of data management activities for all clinical trials from inception to completion. The Director, Biostatistics role is hands-on; the successful candidate will support the conduct of clinical trials in addition to leading the function.
This role is full time and is located in our office in beautiful Vancouver, BC. The ideal candidate will have experience in Phase 3/NCE development, FDA interactions, and in multiple therapeutic areas, including inflammation and oncology.
This is a new and evolving role and can be adjusted to meet the career path and potential of the successful candidate.
- Provides expert guidance, input, analysis and review of statistical and data management deliverables for all studies.
- Provides ongoing guidance to senior management and the development team on statistical recommendations regarding study design, methodologies, goals and interpretation of results.
- Ensures all clinical studies are developed and completed in a manner that supports planned statistical analyses.
- Leads the statistical oversight of all projects, including scope analysis, timelines and budget.
- Leads the development of statistical analysis plans and the generation of statistical analyses for inclusion in clinical study reports, regulatory packages, and publications.
- Writes statistical sections and oversees their integration into clinical documents and amendments including hypothesis testing, sample size calculation, statistical methodology, etc.
- Ensures that Case Report Forms (CRFs) efficiently capture required trial data and are consistent with data standards.
- Leads the development and implementation of data management and programming work plans.
- Oversees data management operations to ensure that data for statistical analyses are collected and delivered on time, in a workable, usable, and understandable format.
- Oversees outsourcing of data management to CROs and supports Regulatory Affairs in negotiating with regulatory authorities on statistical matters.
- Ensures the development, maintenance and adherence with relevant statistical corporate policies and SOPs.
- Develops and maintains an integrated database.
Qualifications and Work Experience
- PhD in biostatistics and 5 years relevant experience; or Master’s degree in biostatistics and 10 years relevant experience; or an equivalent combination of education, training and experience.
- Experience /negotiating with regulatory authority statisticians is required.
- Phase 3/NCE experience required.
- Experienced in US FDA statistical expectations and requirements for developmental clinical studies and in preparing New Drug Applications (NDAs).
- A hands-on individual with experience working in a small emerging biotech/pharmaceutical company.
- Expert understanding and application of clinical trial statistical concepts, techniques and regulatory requirements. Experience with data mining, hypothesis generation and defence.
- Ability to develop, implement and manage statistical analysis plans (SAP).
- Ability to work independently and communicate complicated statistics in an easy to understand format.
- Strong written and oral communication skills including technical writing skills.
- Strong attention to, and accuracy with, details.
- Strong individual initiative, organizational skills and commitment to quality.
- Strong working knowledge of relevant statistical computing packages.
- Ability to travel up to 10% of the time, including internationally.
- Experience working in small molecules, and inflammation and oncology clinical trials would be advantageous.
Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity.
Interested candidates are invited to forward your resume and cover letter summarizing your FDA & small molecule experience and why you feel you are a fit for the Director, Biostatistics role at Aquinox Pharmaceuticals, Inc. to firstname.lastname@example.org.
We thank all applicants for their interest; only those chosen for an interview will be contacted.