Director, Biostatistics

Location
Newark, CA
Posted
May 13, 2022
Ref
4456327004
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Director, Biostatistics

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options.  Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

The Director of Biostatistics will be the Lead Biostatistician and responsible for day-to-day biostatistics tasks for multiple clinical trials of multiple products at Rain Therapeutics. The individual will provide expert and hands-on support to all clinical development programs and regulatory submissions. This position will serve as a statistical lead in the project teams and interact with Medical, Clinical, Safety, Regulatory, Data Management, Programming, Medical Writing etc. in the cross functional team. The Director of Biostatistics will report to the VP of Biometrics and work closely with cross-functional teams at Rain Therapeutics and with external vendors.

 

Key Requirements:

    • Serves as statistical representative and provides statistical and strategic inputs in the cross-functional clinical development team
    • Independently contributes to study protocol development, develops SAP and other study related documents
    • Develops all aspects of preparation and execution of SAP to ensure quality and timely outputs
    • Provides statistically sound scientific methodology in analyzing data, interpreting results, and supporting CSR development, regulatory submission, and publications
    • Performs analysis with advanced statistical method, simulation, and ad-hoc analysis
    • Collaborates with programming and data management to ensure protocol objectives are met in data collection and reporting
    • Provides statistical support in regulatory communications including submissions, meetings, requests, and RTQ
    • Provides oversight and interacts with CRO for the timelines, quality of deliverables, and budget
    • Maintains currency with respect to statistics, regulatory guidelines, data structure, disease states, treatment landscape, and competitor’s status
    • Mentors junior statisticians by setting goals, managing performance, providing trainings

     

Preferred Education and Experience:

  • MS or PhD in Statistics or Biostatistics
  • 10+ years of experiences in the pharmaceutical/CRO industry with support of clinical trials across all phases of development
  • Extensive knowledge of advanced statistical methodology, regulatory requirements, and industry standards for clinical data and reporting on clinical trials
  • Excellent verbal and written communication skills and team player
  • Sound logical thinking, attention to details and accuracy, and problem-solving abilities

Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.