Principal Biostatistician

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

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

EDUCATION

MS in Biostatistics, Mathematics, Statistics, Public Health or related discipline required

PhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred

EXPERIENCE

• Knowledge of SAS statistical computing package is a must
• Knowledge of other database management and statistical software packages is a plus
• 10+ years of experience in statistical analysis of clinical trials data

SKILLS

• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods
• Proficiency in SAS statistical programming
• Knowledge of other statistical and data management software packages is a plus
• 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

Physical 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.

The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.