Statistics, Pharmaceutical, CRO, SAS, CRF, SAP, TFL, ICH guidelines, CDISC data structures, FDA guidelines, FDA

Header: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.

Must have:

Ph.D. or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience SAS computer package industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines Strong organizational, communication, leadership, and problem-solving skills with the ability to lead CRO teams and work both independently and collaboratively to meet deadlines. Review CRF, database design, and edit check specs Prepare and/or review SAP, TFL shells and specifications for variable derivation Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents