CMC Statistician

Location
Menlo Park, CA, US
Posted
Aug 19, 2019
Ref
13E89E1526
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Location: Menlo Park

Reporting to: Vice President, Analytical Operations

The CMC Statistician at Orchard Therapeutics is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Vice President Analytical Operations, this role provides a unique opportunity to contribute your statistical expertise to all aspects of clinical drug development in a dynamic environment.

Requirements
  • Provide scientific direction in statistical design of experiments for bio-pharmaceutical process development and manufacturing, working closely with both internal CMC group and with external CMOs
  • Provide statistical input to process development, characterization and validation, as well as for the setting of specifications and quality attribute trending, in support of regulatory submissions
  • Conduct statistical analysis for complex experimental designs during the development of validation protocols and validation reports, including the design of the experiments
  • Establish standards and processes to ensure that all statistical analyses are performed in a consistent and rigorous manner, using QbD and statistical principles to drive process improvement at both pilot and manufacturing scales
  • Establish statistical tools and data mining to enable a platform approach to development, manufacturing and process validation
  • Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs
  • Author high quality technical reports summarizing statistical designs and methods, data analyses and interpretation


Qualifications
  • PhD with minimum of 4 years, or MS with minimum of 8 years, of relevant experience in the application of statistical techniques in the areas of process development, validation or manufacturing in a medical device, biotech or pharmaceutical industry
  • Education majoring in statistics, biostatistics, or related field with sufficient concentration in chemistry and statistics
  • Demonstrated application of statistical techniques in multiple areas of CMC, process development including:
    • Process characterization and validation
    • Process modelling, capability and trend analyses
    • Data mining large sets of process and manufacturing history and presenting through data visualization plots, mathematical modelling and prediction profiling
    • Data trending and tracking
  • Expertise in a wide range of statistical techniques including, but not limited to, linear and non-linear mixed modeling, generalized linear modeling, multivariate and non-parametric analysis, experiment design, process improvement methodologies and statistical data mining
  • In-depth knowledge and extensive programming abilities in SAS, JMP, R, Matlab and/or other programming languages for statistical applications in pharmaceutical industry
  • Excellent oral and written communications skills
  • Experience in writing technical protocols
  • Ability to communicate complex statistical concepts to non-statisticians
  • Demonstrable project management and interpersonal skills
  • Self-starter with the ability to work on a cross-functional team
  • Experience working in rare diseases or in trials with small populations would be an advantage