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Rockbridge Search & Recruitment 11/01/2021

Principal Biostatistician

Ref #: 407
Location: S. California S. California 92101
2021-04-11
Salary: $160k-$175k
Sector: Life Sciences
Type: Permanent

We are seeking a Principal Biostatistician responsible for designing, monitoring, and analyzing clinical trials as well as solving statistical problems for R&D, QA, QC and Marketing and Manufacturing.

 

Duties & Responsibilities:
  • Manages resources, project priorities and timelines for assigned projects and clinical trials, as well as manages resources across all biostatistics projects.
  • Expert resource for investigating and implementing complex statistical theory and methods.
  • Key participant in strategy development and contingency planning.
  • Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
  • Mentors and directs more junior biostatisticians.
  • Act as key or primary contributor to FDA (and other regulatory) interactions regarding experimental design and statistical analysis.
  • Designs, documents, tests and implements complex statistical analysis methods in collaboration with Clinical Affairs and other departments.
  • Ensures biostatistical methods, equipment and practices are in compliance with current regulatory regulations and guidelines.
  • Ensures statistical integrity of tables/listings/graphs and statistical analyses that support regulatory submissions and formal organizational statements and documents such as press releases and annual reports.
  • Maintains expertise in state-of-the-art statistical analysis techniques.
  • Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
  • Develops programs to perform statistical analysis and present results. Work with SAS programmers to ensure appropriate data analysis and presentation is performed.
  • Provides input on Data Management SOPs and develops Biostatistical SOPs and work instructions.
  • Writes and/or reviews Statistical Analysis Plans (SAPs) and develops and/or reviews table/listing/graph shells for statistical analyses and reports.
  • Interfaces with clinical investigators and scientists to determine protocol design.
  • Writes and/or reviews the statistical and data analysis sections for regulatory submissions.
  • Acts as a resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results.

 

Qualifications:
  • Advanced knowledge of CRF and database development, including attribute assignment and logic checking.
  • Advanced knowledge of applicable FDA regulations and policies regarding study design, conduct, monitoring and data analysis software program validation for database design and clinical trial data management.
  • Expert knowledge of statistical software packages such as SAS, JMP or R.
  • Expert knowledge of common and highly complex statistical theory and methods for clinical trials, design of experiment and quality control.
  • Knowledge of business strategy, product development and risk mitigation.
  • Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
  • Knowledge of infectious disease, cancer, genomics and common public health issues.
  • Good technical writing skills.

 

Education:
  • BS or MS
  • MS preferred
  • Degree in statistics or closely related field strongly preferred

 

Experience:
  • 8-10 years related experience (MS)
  • 10-12 years related experience (BS)

 

 

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