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Phase 1 Statistician
Ref No.: 18-06738
Location: west chester, Pennsylvania
Position Type:Full Time/Contract
Start Date: 06/05/2018
Position Summary

The Principal Statistician position is for a skilled scientist with training and experience in statistics, drug development, and clinical research. He or she is expected to design phase I studies within Client Global R&D, including pharmacokinetic and bioequivalence/bioavailability studies, pharmacodynamics, QT/QTc studies, and the earliest studies in humans. The support includes, but not limited to, study designs and data analyses. He or she needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks. A Principal Statistician should be a strong individual contributor, demonstrating leadership qualities and creative and strategic thinking. He or she should have experience with regulatory interactions both in the US and outside of the US. He or she must have excellent written and oral communication skills.

Essential Functions:
  • Responsible for study designs and data analyses from Phase I studies, including pharmacokinetic and bioequivalence/bioavailability studies, pharmacodynamics, QT/QTc studies, and the earliest studies in humans
  • Responsible for statistical aspects of the analysis of pharmacokinetic data from Phase II and Phase III studies and exposure-response analyses
  • Provides study design input and consultation for clinical endpoint assessments and sample size planning for clinical pharmacology studies
  • Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with Clinical Pharmacology personnel, and with Clinical Research, as deemed necessary.
  • Writes, or oversees the writing of, statistical analysis plans
  • Works with Data Management and Clinical Research personnel to provide statistical input for CRF design
  • Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of Client Global R&D products
  • Conduct, or oversight of the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses and regulatory responses.
  • Leads efforts to select CROs for outsourcing of statistical activities when required
  • Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate
  • Support the development (and adaptation) of the strategy around the Clinical Pharmacology Operating Model
  • Proactively assess and identify processes that require improvement
  • Help develop and maintain departmental SOPs and ensure their compliance in daily work

  • Ph.D. in Statistics/Biostatistics (or related field) with a minimum of 3 years of related experience or MS/MA with a minimum of 6 years of experience is required;
  • Good presentation and written communications skills.
  • Ability to communicate with non-statisticians to interpret statistical findings
  • Experience working in an outsourcing model (fully or functional outsourcing)
  • Good organizational and problem-solving skills.
  • Demonstrated project and technical leadership qualities, and creative and strategic thinking preferred.
  • Ability to program using SAS
  • Knowledge of CDISC SDTM and ADaM
  • Knowledge of relevant FDA and CHMP guidelines
  • Experience with regulatory interactions in the US
  • Experience with regulatory interactions outside the US