Job Title

Salary: $190,000 to $240,000On-Site: South San Fran, CAResponsibilities:Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teamsOversee all the studies for one compound to ensure the consistency of statistical work standards as the project statistical leaderResponsible for writing statistical methodology section of the protocol, including sample size calculationResponsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISSISEPlan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activitiesDirect the activities of internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standardsReview and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documentsParticipate in operations meetings, project team meetings, and address issues related to biostatisticsSupport and participate in the preparation of study reports, regulatory submissions, and annual safety update reportsPerform ad hoc analysis and data validationDevelop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes including IWRSEDC, STDM, statistical programming for TLFs, and data reportingQualificationsMaster's degree in statistics or biostatistics with 8+ years of biopharmaceutical statistics experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industryAbility to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on timeExperience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environmentKnowledge of missing data handling, multiple comparisons, and simulation techniquesExperience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.Good working knowledge of ICH, FDA and GCP regulations and guidelinesStrong leadership skills and teamwork spirit