CMC Statistician - FM15
Menlo Park, California, United States
Location: Menlo Park
Reporting to: Vice President, Analytical Operations
Orchard Therapeutics Limited is a global biotechnology company dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.
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.
- 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
- 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
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k).
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.