Sr. Statistical Scientist/Principal Statistical Scientist

Location
Redwood City, CA
Posted
May 23, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Adverum is looking for a Sr. Statistical Scientist/Principal Statistical Scientist to join our team in our Redwood City office. This position reports into the Sr. Director, Biostatistics.  This role interacts with members in the cross-functional teams in Clinical, Regulatory, and Medical Affairs, as well as other company Research Laboratories Scientists to provide statistical and analytical direction, insights, recommendations, and overall input into the clinical development of related drug/vaccine projects.
What you'll do:
  • Serves as a statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
  • Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
  • Participates in database design meetings to ensure that the data evaluated are of high quality and satisfy analysis requirements.
  • Collaborates with the biometrics vendor and/or internal statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
  • Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
  • Analyzes data and interprets results from clinical trials to meet the objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.
  • Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
  • Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
  • Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
  • Involved in research activities for innovative statistical methods and applications in clinical trial development
  • Other responsibilities may be assigned as needed

About you:
  • Ph.D. or equivalent degree in statistics/biostatistics or related discipline, or a Master’s degree with a minimum of 3 years of relevant experience (6 years for Master’s degree)—PhD preferred.
  • Knowledge of statistical analysis methodologies relevant to clinical research and experimental design.
  • Working experience of analyzing clinical and analytical data at both prespecified and post-hoc settings.
  • Strong programming skills in in SAS, and a plus, in R and other statistical and data processing software.
  • Experience in overseeing biometric vendors is a plus.
  • Experience in BLA/NDA filings is a plus.
  • Experience in ophthalmology, especially retinal diseases, is a plus.
  • Good oral and written communication skills. Able to work effectively with personnel with different functional backgrounds.
  • Demonstrate a strong interest in statistical research activities and in the application of novel methods to clinical trial development.
  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
  • An understanding of the biology of disease and drug discovery and development.

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation