Senior Director, Biostatistics

About the CompanyProtego 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 jobServes 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 ResponsibilitiesProvide 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 studiesRepresents 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 reportIdentifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studiesRepresents Biostatistics in interactions with regulatory agenciesPrepares, reviews, and approves statistical analysis plansOversee contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programsOversees 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 toExperience with statistical approaches to outcomes-driven clinical trialsProvides biostatistical support to nonclinical teams as neededAssists in the development of department standard operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical softwareReviews, approves and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designsAssumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met Performs other duties as assigned Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.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 expertiseApplies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovativelyAbility to work as part of and lead multiple teamsSees broader picture and longer-term impact on companyExcellent leadership, coaching and development skillsStrong negotiation and influencing skillsExcellent communication, problem-solving, analytical thinking skillsExcellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlinesSignificant expertise in the design, analysis, and reporting of clinical studies, including innovative and adaptive study designs and advanced statistical analysis methodsDemonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activitiesAdvanced knowledge of SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study dataThorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study dataExperience in interacting directly with regulatory authorities in meetings and written communications Salary$235,000 - $260,000 a yearIn addition to a competitive base salary ranging from $235,000 to $260,000, we offer stock options, and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-timeBenefits Annual bonus programIncentive stock option plan401k plan with employer contributionComprehensive medical insurance Dental and vision insuranceHSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness)Paid Time OffCompany Paid HolidaySchedule Monday to Friday Work Authorization United States (Required) Additional Compensation Annual targeted bonus % Work Location: San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required. Equal Opportunity Employer Protego Biopharma is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. xhyhwjd Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.