Pfizer
Location
Chennai | India
Job description
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job. · A highly productive, independent programming lead ensuring excellence in the delivery of analysis · ready datasets, tables, listings, and figures to advance research, development, and commercialization · of the company portfolio following the SOPs and processes · This role is the programming point of contact at the study level, and will support at the asset/submission level. · Ensures adherence to high quality programming standards in the production of clinical reports. · JOB RESPONSIBILITIES · Indicate the primary responsibilities critical to the job. · Will deliver through combination of oversight of vendors/offshore support as well as through hands on · programming · Works with department leadership and project teams to establish strategy, timelines, and resourcing · of statistical programming and analysis deliverables for their study(ies). · Accountable for the quality and timely delivery of datasets and displays required for their clinical study · reports as well as other asset level deliverables they may contribute to under the leadership of the · asset lead. Ensures appropriate documentation across the lifespan of the study for all programming · deliverables and verifies proper Trial Master File filings when appropriate. · Ensures planning is in place for all programmed deliverables including consideration of special data · types and downstream uses of data · Works with statisticians, programming resources and other colleagues as appropriate to ensure clear · specifications for programmed deliverables are in place. · Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to · their project, may aid in development of standards necessary for their study · Will contribute to department level initiatives. · Proactive at communicating potential issues to upper management · Anticipates and solves routine problems, while developing the ability to solve complex problems using · skills based on experience and extrapolation to new situations. QUALIFICATIONS / SKILLS Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills. · Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field. · At least 8 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. · Statistical Programming and SAS hands-on experience · Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data. · Good understanding of ICH and Regulatory Guidelines · Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations. · Thorough understanding of clinical data and relevant data standards · Extensive knowledge of routine statistical methodology and its application to programming · Knowledge of vendor processes · Demonstrated experience in developing successful partnerships within study teams · Strong written and oral communication skills, and project management skills · Ability to present technical information to a non-technical audience · Proven ability to operate independently. · Some exposure working across international boundaries and cultures. · Ability to manage customer expectations. · Ability to manage work of others in a remote and/or global setting · CDISC experience highly desirableJob tags
Salary
