Principal Statistician
Company: WuXi AppTec
Location: San Diego
Posted on: October 25, 2024
Job Description:
The primary responsibilities of this position are to provide
statistical consulting to clients in the biotech/pharmaceutical
industry in their drug development programs with a focus on
protocol/study design, analysis planning, and regulatory submission
strategies. - - -
Provide statistical consulting to
clinical study designReview study protocols and write statistical
sectionsConduct sample size and power calculationsPropose
randomization methods and designsLead regulatory submission
strategy planning for statistics functionIdentify issues, and
provide solutions to clinical operation and data management for
issues that potentially impact data analyses Review and provide
comments to statistical analysis plans that are written by the 3rd
partyDevelop statistical analysis plans, both for individual
studies and integrated analyses for regulatory submissionsWrite
statistical reports for results interpretation, both for individual
studies and integrated analyses for regulatory submissions, if
neededPrepare statistical sections of clinical study reports if
neededParticipate in clinical results interpretation meetings, both
for individual studies and integrated analyses for regulatory
submissionsWork with medical writers to assist with clinical study
reports and ISS/ISE reports preparationReview clinical study
reports and other regulatory submission documents Mentor junior
statisticians in their support of client projectsEnsure that
statistical personnel follow the standard operating
proceduresEducation
- Master's or Doctoral degree in statistics or
biostatisticsExperience
- Master's degree with 6-10 years or Doctoral degree with 4-8
years of relevant experience in a health sciences research
institute or the pharmaceutical/biotech industry
- Direct participation in design, planning, conduct, analyses,
and reporting of clinical trials
- Direct participation in regulatory submission activitiesSkills
- Deep understanding statistical concepts and methodology related
to clinical trials and drug development
- Comprehensive knowledge on regulatory guidelines
- Excellent organizational and project management skills
- Excellent interpersonal and communication skills -This job
description does not state or imply that the above are the only
duties and responsibilities assigned to this position. Employees
holding this position will be required to perform any other
job-related duties as requested by Management. -An Equal
Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability. -
Keywords: WuXi AppTec, Mission Viejo , Principal Statistician, Other , San Diego, California
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