Job DescriptionEssential Job Duties and Responsibilities:
Education and Training:
- Assist in planning modeling and simulation projects within existing Consortia, PPPs, and programs at C-Path
- Execute modeling/statistical analysis plans.
- Accountable for implementation of modeling/statistical analysis plans based on agreed upon best practices (i.e. model-based drug development).
- Works with multifunctional internal and external teams to deliver and report the assigned quantitative tasks.
- Responsible for use of quantitative methods to integrate disease-specific knowledge and clinical considerations for optimizing drug development.
- Responsible for appropriate summarization and interpretation of results of data analyses with respect to their impact on development of quantitative drug development tools.
- During the planning stages, works with internal and external teams to ensure that principles of model-based drug development have been applied.
- Prepare scientific summaries and reports which will be used for regulatory submissions and publications.
- Other duties and responsibilities may be assigned.
- PharmD, PhD, or equivalent training or experience in statistics, biostatistics, applied mathematics, pharmacometrics, systems pharmacology, engineering, engineering, pharmaceutical sciences or related discipline.
- Proficiency or experience working in team settings.
- Quantitative methodologies: demonstrates thorough understanding of, or aptitude to learn, quantitative methods used in drug development: 1) statistical modeling, (mixed-effects models, survival models, Bayesian methods)
- Software: demonstrates thorough experience coding in formal and/or modeling software platforms.
- Communication: demonstrates ability to effectively present quantitative results, development plans, and strategies to technical and non-technical audiences in verbal form
- Writing: demonstrates ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
- Time Management: Ability to meet target deadlines and manage time effectively, balanced across multiple projects.
- Networking and Alliance Building: good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of consortia objectives.
- Innovation: constantly looking for new approaches and able to devise/apply new techniques in quantitative medicine, clinical pharmacology and modeling and simulation.
- Courage with Decisiveness to Act: bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to the development of drug development tools.
- Values: Practice highest level of integrity and core value system consistent with C-Path's core values.
- Clinical Pharmacology: knowledge of principles of PK, PK-PD, phase I-III studies of drug development, biopharmaceutics, pathophysiology and therapeutics is desirable.
- Regulatory Knowledge : understanding of appropriate FDA, EMA and ICH guidelines in the design of analysis plans is desirable.
- Proficient use of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.
- Proficient in programming in at least one of the following: R/STAN [preferred], Python, NONMEM
- Additional expertise with other quantitative tools (e.g., SIMCYP, GastroPlus, Matlab, Phoenix [Winnonlin, NLME], Stan, BUGS) or programming languages (e.g., C++, Java, Perl) a plus
- Regularly required to sit for long periods of time, and occasionally stand and walk about the facility.
- Regularly uses hands to operate computer equipment and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, and lift up to 25 pounds.
- Travel on occasion for out-of-town meetings (~ 10%).
In accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, C-Path has adopted a policy to comply with this requirement all C-Path employees must vaccinated to safeguard the health of our employees and their families; our customers and visitors; and the community at large from COVID-19.Reasonable Accommodation:
Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department. Job Posted by ApplicantPro