Principal Biostatistician

Prometrika LLC•Cambridge, MA

About The Position

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 Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results

Requirements

MS in Biostatistics, Mathematics, Statistics, Public Health or related discipline required
Knowledge of SAS statistical computing package is a must
10+ years of experience in statistical analysis of clinical trials data
Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods
Proficiency in SAS statistical programming
Strong written and oral communication skills
Knowledge and experience with CDISC data standards and models
Strong project management and mentoring/leadership skills
In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to effectively manage multiple tasks and projects
Ability to clearly describe statistical techniques and interpret results

Nice To Haves

PhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred
Knowledge of other database management and statistical software packages is a plus
Knowledge of other statistical and data management software packages is a plus

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 scenarios
Perform sample size calculations and write statistical methodology sections for inclusion in study protocols
Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions
Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable
Develop SAS programs to produce and/or QC statistical tables/figures/data listings
Perform mapping from raw datasets to CDISC SDTM datasets
Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission
Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data
Maintains expertise in state-of-the-art statistical analyses
Review and/or write the statistical and results sections of clinical study reports
Review and/or assist in writing publications
Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
Manage multiple projects
Provide 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 review
Provide training and guidance to junior level and new staff
Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis
Support proposal development and attend bid defense meetings
Review Request for Proposal (RFP) and Scope of Work (SOW) documents
Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks
Manage project budget and forecast resources needed for studies
Additional responsibilities as assigned by supervisor/manager