Director (or Associate Director), Biostatistics
ADELA is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis, and management and in the future will be applied to other conditions beyond cancer.
Summary
ADELA is seeking a highly motivated and creative individual to join the biometrics team. This is an exciting opportunity to be part of a growing, dynamic, and collaborative company delivering cutting-edge technology directly to clinicians and patients. We are looking for a Director (or Associate Director) in Biostatistics who will provide statistical expertise and leadership in clinical studies! This position will partner with key internal and external stakeholders to design, analyze, and interpret clinical studies in support of ADELA’s clinical development. This position will also provide statistical modeling expertise and conduct simulations in support of ADELA’s product development and scientific discovery. Finally, we are searching for a candidate who is flexible and enthusiastic to help meet the needs of a growing company.
Responsibilities
* Provide strategic input and be a key contributor to product development and development of the biometrics department.
* Represent the Biostatistics function and collaborate with internal and external thought leaders in the design, operation, analysis, and interpretation of clinical studies.
* Write and review statistical analysis plans.
* Provide guidance and supervision to statisticians and programmers in authoring of analysis dataset specifications and programming of tables, figures, and listings.
* Co-author study protocols, clinical study reports, presentations, and publications of clinical studies.
* Contribute to the development of innovative statistical methodologies, including cutting-edge statistical learning algorithms.
* Work on significant and unique issues that require exercising independent judgment and developing/adapting methodology.
* Stay abreast of industry and academic developments in Statistical Genomics and apply new methodologies to clinical study design and analysis.
* Participate in regulatory activities such as health authority meetings and submission related activities.
* Review and/or author SOPs and guidelines related to biostatistics practices.
Qualifications
* Ph.D. degree in Biostatistics or Statistics.
* Ph.D. with 7+ years of experience in Pharma, Biotech, or Regulatory agencies will be considered at the Associate Director level.
* Ph.D. with 10+ years of experience in Pharma, Biotech, or Regulatory agencies will be considered at the Director level.
* Strong knowledge of theoretical and applied statistics.
* Experience programming in R, Python or Julia.
* Proven track record of success in leading clinical studies and statistical portion of a clinical development program as a biostatistician.
* Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA.
* Experience in dealing with health authorities such as discussions / negotiations in filing strategies.
* Outstanding verbal, writing, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.
* Experience managing and developing other biostatisticians is highly desirable.
* Experience with machine learning techniques and genomic data analysis is a plus.