Senior Biostatistician

Leadership & Project Oversight Serve as the lead biostatistician on clinical study teams, accountable for statistical deliverables, quality, and timelines. Provide mentorship and oversight to statisticians and statistical programmers. Communicate project progress, risks, and resource needs to leadership. Ensure alignment of project execution with departmental and organizational goals. Study Design & Statistical Strategy Lead the statistical design of clinical studies, including protocol development and statistical methodologies. Perform and review sample size and power calculations. Develop, review, and finalize statistical analysis plans (SAPs). Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives. Data Management & Systems Collaboration Provide statistical input into electronic data capture (EDC) design. Partner with data management to define edit checks and ensure high-quality data collection. Ensure study data supports interim and final analyses and regulatory requirements. Statistical Programming & Analysis Develop, validate, or oversee statistical programming using SAS and other tools (e.g., R, Python). Review outputs for accuracy, quality, and compliance with standards. Guide programming specifications, table shells, and reporting frameworks. Reporting & Scientific Communication Lead preparation and review of interim analyses, final study reports, and regulatory submissions. Contribute to manuscripts, abstracts, integrated summaries, and ad hoc analyses. Communicate complex statistical concepts and results to non-statistical stakeholders and senior leadership. Regulatory Compliance & Quality Assurance Ensure compliance with GCP, FDA, ICH, and other applicable regulatory standards. Maintain audit-ready documentation and high-quality, submission-ready deliverables. Contribute to the development and refinement of statistical SOPs and best practices. Collaboration & Stakeholder Engagement Collaborate with clinical operations, data management, physicians, and external partners. Interface with regulatory agencies, data monitoring committees, and steering committees. Build strong client relationships and support business development initiatives. Specialized & Strategic Contributions Provide statistical consulting across therapeutic and technical domains. Support specialized activities such as randomization design, unblinded statistician roles, and integrated summaries of safety and efficacy. Represent the organization through publications, conference participation, and professional engagement. Qualifications PhD or Master’s degree in Biostatistics, Statistics, or related field with at least 5 years of experience in clinical trial data analysis Demonstrated programming proficiency in SAS (version 9.0 or higher) Experience supporting Phase I–III clinical trials Strong knowledge of ICH guidelines and regulatory requirements; familiarity with FDA submission processes Familiarity with CDISC standards (e.g., SDTM, ADaM) for regulatory submissions Proven leadership experience managing projects and mentoring team members Proficiency with Microsoft Office tools (Word, Excel, PowerPoint) Experience working on integrated summaries of safety and efficacy (ISS/ISE) or similar large-scale reporting efforts Strong analytical, organizational, and problem-solving skills with high attention to detail Excellent communication and interpersonal skills, with the ability to convey complex statistical concepts clearly Ability to manage multiple trials and priorities simultaneously with minimal disruption to productivity Preferred Knowledge and Experience Experience with FDA/NDA submissions and regulatory interactions Experience working in a client-facing or CRO environment Therapeutic area expertise Proficiency in R, Python, or other advanced analytical tools Track record of contributions to publications, abstracts, or conference presentations Benefits Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) 11 paid holidays 15 - 25 vacation days based on years of service Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) Flexible and remote work schedules Note: Viable applicants will be required to pass a background and education verification check. An Equal Opportunity Employer CPC is dedicated to the principles of equal employment opportunity (EEO). CPC prohibits unlawful discrimination against applicants or employees on the basis of age 40 and over, race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, sexual orientation, gender identity, gender expression, color, religion, creed, national origin, ancestry, disability, military status, genetic information, marital status, or any other status protected by applicable state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at View email address on click.appcast.io. #J-18808-Ljbffr CPC Clinical Research