Build a high functioning and efficient biostatistics department from the ground up and provided strategic statistical guidance to the company. The internal team included three biostatisticians and three SAS programmers at various levels ranging from director to senior programmer. This team supported internal statistics and programming needs for 30 clinical trials for seven different compounds ranging from first in human to Phase 2B dose ranging studies. The production work (Final Tables, Listings, Figures, SAP, and datasets) for some of these studies was completed using in-house resources only, while other projects utilized statistical clinical research organizations which were vetted and managed by the internal group. Statistical strategy was provided at each junction in the clinical development to help progress to the next stage and beyond.

Operated as sole biostatistician for the company and helped progress oliceridine from Phase 2a to NDA. Built internal biostatistics and programming capabilities for the company. Responsible for the statistical sections of the oliceridine NDA. Proposed novel primary endpoint and developed a method based on a zero inflated gamma distribution for measuring and testing the respiratory burden of an analgesic compound. Provided statistical sections of FDA briefing documents and submissions (End-of-Phase 2, Pre-NDA, and the NDA submission). Applied Monte Carlo Markov Chain modeling to predict and provide confidence bands for annual sales forecast of oliceridine once approved. Worked along with the medical affairs group to build Trevena’s publication plan. Wrote standard operating procedures and system specifications for statistics and clinical programming. Managed internal SAS programmers and statistical consultants; trained, reviewed and evaluated performance on a regular basis. Oversaw 3rd party vendors responsible for statistical, programming and data management deliverables. Developed a standard quality vendor management plan for biostatistics deliverables. Organized and managed a summer internship project involving simulation of enrollment data for individual sites to help optimize future site selection.

Lead Statistician for projects in Ophthalmology/Dry-eye, Rare Diseases/ diabetic gastroparesis and delayed gastric emptying in Parkinson’s and critically ill patients, and Dermatology/atopic dermatitis and Psoriasis.Served on the Clinical Statistics Training team with responsibilities for developing and presenting training modules for between trial prediction, stochastic simulation and Bayesian modeling using DoodleBugs.

Served as Lead Statistician for early development immunology therapeutic area and statistical representative for the neuroscience Knowledge Integration Matrix Team. Developed and implemented training material for the clinical pharmacology department that covered foundational statistical concepts as well as modeling and simulation principles. Served as the statistical representative on the ECG taskforce and the early development representative on the global biostatistics symposium committee

Statistical representative on the pharmacometric committee responsible for statistical review of the modeling and simulation portion of clinical development plans.Supported Infectious Disease, Metabolic, and Inflammation therapeutic areas with overall statistical support for Clinical Pharmacology, Pharmacokinetics, Biomarker Development and Validation. Mentored other biostatisticians with regard to technical or operational issues.Summer internship coordinator.

Designed clinical trials; computed sample sizes, developed protocols and analysis plans; provided statistical methodology and analyses for study reports and scientific manuscripts.Project statistician for a synthetic vitamin D analog compound (July 2004).Lead statistician for the NDA for a lipid-regulating compound (Oct. 2003).Lead statistician for the fenoldopam SNDA (Sep. 2002) for an indication in the pediatric population.Clinical trial experience included: Pediatric/Adult Bridging, Marketed Product Phase IV, Drug-Drug Interaction, First in Man Escalating Dose, Formulation Screening, and Renal Impairment.