Member of Global Pharmacometrics group within the Clinical Pharmacology Department, responsible for providing expert study/program design, data analytical and interpretation inputs to various Research, Development and Business Unit organizations. Of key importance will be the formation and maintenance of effective collaborations with among team members, including statistical, clinical and clinical pharmacology colleagues.ROLE RESPONSIBILITIES
- Hands on contribution to MIDD, complementary to Pfizer processes, including Enhanced Quantitative Drug Development (EQDD) and Enhanced Clinical Trial Design (ECTD). Responsible for the planning and execution of relevant quantitative analyses.
- Contribute to the Pharmacometrics group remit in performing MIDD activities (e.g., exposure response analysis, disease progression modeling, quantitative knowledge management, clinical trial design, decision analysis, and EQDD strategy).
- Organize and manage project deliverables utilizing the appropriate expertise and resources (internally within the company and/or externally within consultant groups and academic institutions).
- Act as "player-coach", both conducting modeling and simulation and facilitating conduct of analyses with other quantitative global clinical pharmacology colleagues.
- Prepare formal presentations and written reports to Pfizer standards.
- Contribute to Pharmacometrics ability to act as a conduit for cross learnings within/across the clinical development organizations.
- Provide effective partnership with other colleagues, proactively providing peer review, mentorship, consultancy, and technical input on quantitative issues.
- Promote, educate, and mentor others in application of quantitative techniques and share experiences through appropriate local and global discussions.
- Prepare and deliver training on quantitative tools and methodologies internally to Pharmacometricians and other global clinical pharmacology colleagues.
- Contribute with project teams/partners to regulatory responses and submissions.
- Stay abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge in terms of analytical methodology, medical background, and clinical trial design.
- Able to produce and present quality scientific papers at external meetings and for publication. With line management endorsement, manages and initiates external collaborations with world leading pharmacotmetric and quantitative clinical pharmacology experts to develop new methodologies.
- Recruit, train, develop, mentor, motivate and retain highly skilled Pharmacometricians.
- Work with quantitative colleagues across disciplines to ensure delivery and communication of best practices.
- May represent group on company initiative sub-teams.
- May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
- May collaborate with, enable and influence external key opinion leaders and regulatory authorities in best practices for drug development science through publication, external presentation.
- May develop best-in-class strategic alliances with industrial and academic centers of excellence for drug development and research.
- May participate in and contribute to global computational sciences community of practice.
- Contribute to business requirements/support of IT colleagues/contractors, systems and tools to ensure support services to systems and software tools and colleagues are best in class.
- M.S. with 12+ years or Pharm.D and/or PhD degree with 9+ years of training and/or expertise in one or more areas related to pharmacostatistical modeling.
- An interest and experience of pharmacostatistical methods of data analysis and study design are essential.
- Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology) will be considered if they can demonstrate relevant experience and expertise.
- Strong science and quantitative analysis background, with good working knowledge of biology, chemistry, pharmacology, engineering and/or statistics.
- Good computational skills.
- Good knowledge of a range of MIDD software (R, NONMEM, STAN, etc.).
- Good communication skills (written, oral presentation).
- Balance multiple responsibilities, projects and teams simultaneously.
- Adapt and be dynamic.
- Identify and understand relevant scientific literature and apply knowledge gained from these sources desired.
- Identify/develop and applynew quantitative methods as needed to solve problems in pharmaceutical research.
- Interpret a range of model types and identify scientific, technical and methodology strengths and weaknesses.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Other Job Details
Relocation support available
Eligible for Employee Referral Bonus
Additional Location Information: Groton, CT or US RemoteSunshine Act
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