Lumen is seeking a Statistician to join our team. Lumen’s platform is uniquely suited for developing multi-biologic ‘cocktails’ comprised of many distinct therapeutic proteins or other biologic entities (up to 20 in current programs; more in the future). This requires fresh thinking about how drug development is conducted, and so the right candidate for the job will be someone who is energized by the opportunity to develop a new field, and unlikely to be easily discouraged by ambiguity or the lack of clear precedent.
Essential Duties and Responsibilities
As Lumen’s first in-house Statistician, this person will play a leading role in defining and improving Lumen’s statistical approach to all aspects of drug development and manufacturing processes. Working closely with Lumen’s internal scientific team and external domain-specific statistical advisors in the fields of biostatistics, statistical design of experiments, CMC Quality by Design, assay development, and process optimization and controls, these activities include:
- Development, qualification, and validation of pre-clinical and clinical assays
- Participating in the design of pre-clinical studies involving multiple simultaneous active biologic components (n≤20) using sequentially design of experiments (fractional factorials, definitive screening designs, etc.) — both in vitro and in vivo
- Assisting with the design of experiments directed improving throughput, consistency, reliability, and costs associated with Lumen’s drug development and cGMP manufacturing processes
- Assisting with the development of statistical plans for mid- and late-stage clinical trials
- Working through core team processes with other functional groups within the company developing strategies for clearly conveying the experimental designs and statistical analysis of all of the above, including in the following publication contexts:
- Investigational New Drug applications, biologics license applications, and other regulatory submissions
- Clinical protocols, clinical study reports, investigator brochures, informed consents, clinical trial disclosures
- Reporting materials required under Lumen’s grant-funding arrangements
- External communications, including peer-reviewed papers on pre-clinical and clinical results
- Periodically, grant applications
Being the first full-time statistics position in the company, it is important that the winning candidate be able to serve as a resource to other leaders in the company, including:
- Generally acting as a resource regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results
- Provision of technical solutions and advice on statistical methodology and principles
- Advising and assisting with post hoc analysis of legacy data sets
- Assist the executive leadership team with developing and defining frameworks for decision-making (tenets) to guide and inform future experimental design choices
Initially, it is expected that approximately 75% of the Statistician’s time will be oriented toward pre-clinical and manufacturing activities and 25% or less time directed at clinical-stage activities. Depending on seniority and interests, the team will expand along with the demands of this fast-growing organization, presenting potential opportunities for broader responsibilities.
Desired Qualifications & Requirements
Education and Experience:
- Bachelor’s degree in a field of statistics; master’s degree or doctorate preferred
- Minimum of 5 years of experience in the biopharmaceutical industry
- Strong preference for experience in CMC process optimization and quality by design
- Preference for additional experience in biostatistics and clinical trials
- Additional desirable education and experience:
- IND/NDA/BLA/MAA submissions
- Knowledge of FDA regulations and ICH guidelines, in particular Good Clinical Practices and Good Manufacturing Practices
- Experience with statistical quality control systems such as Lean Six Sigma
The successful candidate will have the following attributes:
- An avid interest in the drug development process and the use of biostatistics as applied to all aspects of the development of novel solutions to various disease processes
- Advanced knowledge of a variety of statistical procedures and experimental design, e.g., statistical design of experiments, linear and non-linear models, adaptive trial design and Bayesian statistics, categorical data, and survival analysis.
- Ability to lead and prioritize multiple projects in a fast-paced environment
- High integrity and ethics
Please submit a resume and cover letter to firstname.lastname@example.org with the job title in the subject line.
Applications will be reviewed upon receipt. Only successful applicants will be contacted.