Senior Director, Biostatistics

About the Company

Protego focuses on the discovery and development of first-in-class small molecule therapeutics that aim to reprogram protein folding for the treatment of various diseases. We are exploring monogenic protein misfolding diseases that cause myopathy, cardiomyopathy, stroke, renal disease, retinal diseases, channelopathies, and various degenerative diseases. Our approach builds on the proven pharmacological chaperones approach previously exemplified by tafamidis, which was discovered and developed by our cofounders Dr.

Jeffery W. Kelly and Dr. Richard Labaudinière, for the treatment of transthyretin amyloidosis.

About the job

Serves as the overall statistical lead on pivotal clinical program and provide statistical input in strategy, design, analysis, and reporting of clinical studies to expedite the conduct and evaluation of clinical trials and basic research. Leads statistical analysis and maintains standards across studies within a clinical program. Maintains expertise in new and innovative statistical analysis methodology. Interacts with key opinion leaders on protocol design.

Oversees and directs the contract biostatistics resources responsible for the analysis and reporting of data from clinical studies.

Primary Responsibilities

• Provide statistical leadership and strategic input to the development team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies
• Represents Biometrics on the development team or clinical sub team (as appropriate for the clinical program)
• Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study report
• Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies
• Represents Biostatistics in interactions with regulatory agencies
• Prepares, reviews, and approves statistical analysis plans
• Oversee contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programs
• Oversees and monitors CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to
• Experience with statistical approaches to outcomes-driven clinical trials
• Provides biostatistical support to nonclinical teams as needed
• Assists in the development of department standard operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical software
• Reviews, approves and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs
• Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met
• Performs other duties as assigned

Required Education, Experience, Skills, And Abilities

• PhD or Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and reporting of clinical studies.
• Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
• Direct experience interacting with regulatory authorities.
• Considered an expert within the company and may have external presence in area of expertise
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Ability to work as part of and lead multiple teams
• Sees broader picture and longer-term impact on company
• Excellent leadership, coaching and development skills
• Strong negotiation and influencing skills
• Excellent communication, problem-solving, analytical thinking skills
• Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines
• Significant expertise in the design, analysis, and reporting of clinical studies, including innovative and…