LFB USA - Statistical Programmer

US-MA-Southborough
Job ID
2017-1291
# of Openings
1
Category
Clinical/Medical
Type
Full Time
Company
LFB USA

Overview

The lead statistical programmer is responsible for providing project leadership from statistical programming perspective in a cross-functional project team environment, and supports all the statistical programming aspects for assigned projects.

Responsibilities

·        Serve as lead statistical programmer to support the clinical programs, review or contribute to key Biometry documents to include but not limited to statistical analysis plans (SAPs) and TLF shells, data validation plan, programming specifications, and data analysis as appropriate.

·        Responsible for providing strategic programming input to facilitate key reporting deliverables to include metadata, datasets, and TLFs.

·        Support key data management activities to include CRF development, database build, data review and reconciliation, and database lock activities.

·        Develop and validate/QC SAS programs for TLFs and SDTM/ADaM datasets associated with a clinical study, ad hoc report, submission, and publication.

·        Ensure proper documentation and upkeep of programming metadata to include but not limited to programming specifications, reviewer guides, Pinnacle 21 reports, and define.xml.

·        Develop/review TLFs and programming specifications in collaboration with Biometry and other clinical development colleagues as appropriate.

·        Support oversight of vendors that conduct statistical work, including the production and QC of the statistical deliverables, ensuring accuracy, consistency, and quality output.

·        Work closely with the Biostatistician and Data Manager during dry-runs to QC key efficacy and safety data and resolve identified data and programming issues.

·        Contribute to the development and revision of statistics SOPs and process improvement.
 

 

Qualifications

  • PhD Statistics/Biostatistics or related field with at least 10 years clinical trials experience in Biopharma/CRO and at least 5 years of people management.
  • Excellent knowledge of drug/biologics development process and thorough knowledge of regulatory guidelines to include GCP and ICH guidelines.
  • Excellent knowledge of therapeutic-specific guidelines related to Biometry work.
  • Good statistical programming skills with SAS and/or R and experience with statistical software such as EAST and nQuery.
  • Familiarity with CDISC requirements for SDTM and ADaM.
  • Demonstrated IND/NDA/BLA/MAA experience.
  • Excellent communication, presentation, and report writing skill, and ability to explain complex statistical technical details in simple language.
  • Excellent project management skills, demonstrated leadership, and ability to monitor/oversee multiple projects simultaneously.
  • Professional attitude, team-oriented, and ability to work independently.

 

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