Sr. Principal, Statistics

About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of Job Role is on-site in Paramus, New Jersey The resource will be responsible for designing and overseeing the statistical framework of clinical studies, from protocol review and sample size calculation through to the preparation of Statistical Analysis Plans (SAPs), tables/figures/listings (TFLs), and regulatory response support. The position requires close collaboration with Statistical Programmers, Clinical Data Managers, and cross-functional study teams to ensure data quality, analysis integrity, and timely delivery of statistical deliverables. Additionally, the role involves oversight of CRO activities and deliverables, contributing to study reports, manuscripts, and health authority submissions throughout the full clinical trial lifecycle. Primary Responsibilities • Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. • Review CRF, database design, and edit check specs • Review study quality surveillance plan and monitor study conduct • Prepare and/or review SAP, TFL shells and specifications for variable derivation • Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables • Provide statistical and validation support for statistical analysis, analysis datasets and TFL • Review study report, manuscripts and other documents related to statistics • Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents • Perform other ad-hoc statistical activities as needed • Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming • Participates in monitoring CRO activities and reviewing CRO deliverables Additional Responsibilities • Performs other related duties and assignments as required Qualifications • Excellent knowledge of SAS computer package • Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines • Excellent organizational skills, time management, and ability to meet established deadlines • Excellent communication and interpersonal skills to effectively interface with others • Ability to work independently and problem-solve • Ability to provide leadership for the CRO statisticians and statistical programmers Education & Certifications • Ph.D or MS in Statistics or Biostatistics • Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: • Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. • Operate other office productivity machinery, such as a calculator, scanner, or printer. • Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity Statement USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Compensation Salary/Hourly Rate Range (W2): USD 80.00 - 90.00 The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget. Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program. For more details about our benefits, visit us here: https://usdm.com/careers