PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.
RESPONSIBILITIES
Management Responsibilities :
- Lead and supervise junior level biostatisticians and provide mentoring and guidance using positive, progressive, and proactive management style
- Act decisively, exercise good judgment and make effective, sound, timely and informed decisions
- Seek to identify, analyze and resolve problems effectively
- Manage project budgets and forecast resources needed for studies
- Participate in capabilities and bid defense presentations and assist with development of budgets and proposals
Biostats Responsibilities :
Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenariosPerform sample size calculations and write statistical methodology sections for inclusion in study protocolsDesign statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissionsDesign analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicableDevelop SAS programs to QC statistical tables / figures / data listingsDevelop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsorReview and / or write the statistical methods and results sections of clinical study reportsReview and / or assist in writing publicationsReview case report forms and data validation guidelines to ensure quality and integrity of study data collectionProvide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC reviewUnderstand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysisMake presentations in industry meetings sharing experiences / methods with the greater clinical trials communityAdditional responsibilities as assigned by supervisor / managerEDUCATION
Master’s degree in statistics or biostatistics, PhD preferredEXPERIENCE
Knowledge of SAS statistical computing package is a must.Knowledge of other database management and statistical software packages is a plusMust have a minimum of 10 years of experience in clinical trials, including protocol design activitiesMinimum of 1 year of staff management experience requiredSKILLS
Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methodsProficiency in SAS statistical programmingKnowledge of other statistical and data management software packages is a plusStrong written and oral communication skillsKnowledge and experience with CDISC data standards and modelsStrong project management and mentoring / leadership skillsIn-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesAbility to effectively manage multiple tasks and projectsAbility to clearly describe statistical techniques and interpret resultsPHYSICAL REQUIREMENTS
Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception / clarity and muscle control / coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.
