Staff Statistician

at  Quantum Leap Healthcare

SUMMARY AND DETAILS OF POSITION

We are seeking an exceptional Staff Statistician with strong statistical and computational skills to support multiple complex clinical trials in Oncology and COVID. The Staff Statistician is responsible for leading and performing biostatistics and statistical programming activities in these trials, which may be Phase I, II and III pharmaceutical trials and medical device trials evaluating new biomarkers and/or therapeutics. The trials also involve real world evidence generation, patient reported outcomes (PROs) and analysis of complex big data sets. The ideal candidate will have 5+ years of experience with Ph.D. in Statistics/Biostatistics, with independent responsibility for biostatistics functions. In a senior role, this individual will be able to contribute to strategic plans and translate those plans into well-managed projects.

PREFERRED EDUCATION AND EXPERIENCE

• PhD in Statistics or Biostatistics with 5+ years of relevant work experience in industry or academia, or
• PhD in related discipline or MS in Statistics or Biostatistics with 7+ years of relevant work experience
• 2+ years of experience in Oncology, COVID, or ARDS
• Experience in Phase I, II and III pharmaceutical clinical trials, preferably in trials whose data was submitted as part of an investigational new drug (IND) or new drug application (NDA) to the FDA.
• Outstanding project management skills. Proven ability to effectively collaborate with internal and external stakeholders, and mentor junior staff.
• Attention to detail including proven ability to manage multiple, competing priorities. Ability to prioritize and drive results with a strong emphasis on quality.
• 5+ years’ experience in Bayesian clinical trial methods, experience in adaptive clinical trial designs
• Proven Track record of publication & research leadership, including presentations at conferences and meetings.

OTHER PREFERRED SKILLS

• Professional working knowledge of theoretical and applied statistics, preferably in clinical trials and adaptive designs.
• Proficient statistical programming and analysis skills, preferably in R.
• Strong interpersonal and motivational skills.
• A self-starter, who excels in a fast-paced and dynamic work. Ability to take the initiative while operating effectively with peers.
• Experience in managing statistics vendors and consultants.
• Excellent oral, written and presentation skills.
• Excellent understanding of the business processes, GCP standards and software used in clinical trials, outcomes research and real-world evidence generation.
  Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
  We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class

• Performs, directs, and defines the approach of statistical activities in collaboration across functions and key stakeholders without supervision. Activities may include, but are not limited to, design and execute clinical trials under GCP/ICH, guide stakeholders to choose appropriate study endpoints, conceive and write Statistical Analysis Plans (SAPs) and statistical sections for clinical trial and research protocols, perform sample size calculations to determine adequate number of research subjects, TLF templates, pre-specification of the statistical methods to produce interim results and guide adaptation decisions, and comprehensive data access plan to maintain trial integrity.
• With the application of advanced statistical methodology, conducts trial simulations and prepares simulation reports for adaptive trials. Writes and review simulation code, including formulas and instructions to run code, in a format that is reportable to the FDA for review. Communicate findings to author to collaborate across multi-level team. Evaluates important operating characteristics of the proposed design as compared to alternative adaptive and non-adaptive designs.
• Serve as primary contact with I-SPY research network to advance publications around assigned trials.
• Translate statistical concepts and analysis into communication tools, such as a presentation, to provide to the Executive team.
• Plans, performs, and reviews statistical analysis for ongoing studies and recommends final interpretation to an executive audience in conjunction with senior management and external collaborators.
• Specify endpoint analysis methods and data subsets to be analyzed, conduct statistical analysis, and interpret results as needed.
• Designs, coordinates, and produces analysis deliverables for pharmaceutical partners.
• Oversee the development and preparation of statistical reports, tabulations, and graphs for presentation at meetings or conferences, and for publication in technical journals.
• The primary role is an individual contributor but will provide guidance to and/or oversight of more junior personnel as needed.
• Organizes complex analysis projects, defines scope of work and timelines.
• Identifies the need for missing documentation and authors standard operating procedures (SOPs) and work instructions as developed or updated to support the quality and timeliness of team deliverables.
• Develops packages for statistical programming and analysis, preferably in R;
• Reviews and/or validates standard programs and macros written by statistical programmers and ensures appropriate guidance on documenting programming code so as can be submitted to FDA and/or external partners.
• Independently author clinical study reports.
• Remains current about new developments in Biostatistics and utilizes learnings to contribute to strategic initiatives in Statistics and Clinical Data Management.