Job Title

Project Role: Senior Biostatistician / Statistical Scientist Work Experience: 7+ Years. Must Have Skills: Over 7 years of strong experience as a Biostatistician, with extensive expertise in clinical trials and SAS. Experience required: Proven ability to independently lead studies & Strong pharma or CRO experience is mandatory. Job Overview: Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance, and mentorship to lower-level and new staff. Essential Functions: Production of High-Quality Deliverables: Completes and reviews complex tasks with a focus on accuracy, conducts validation requirements, checks programming logs, and resolves data issues. Leadership: Perform statistical team lead role on single studies, build and maintain customer relationships, drive statistical discussions, and provide support for statistical activities. Data Management: Assist in reviewing database design, validation checks, and critical data, handle data issue resolutions, and manage lock and unblinding processes. Statistical Analysis Plan (SAP) and Shells: Author or perform quality control review (QC) of SAPs and shells, utilize organizational resources, and handle complex SAPs. Datasets: Write and maintain programming specifications, program datasets to industry standards, and manage dataset derivations. Tables, Listings, and Figures (TLFs): Write programming specifications, program TLFs, ensure consistency, and validate outputs. Timelines: Plan and document timelines, forecast resource needs, and identify out-of-scope work. Financials: Share accountability for financial success, control costs, maximize revenue recognition, and manage budget expectations. Knowledge Sharing: Train and mentor junior staff, support colleagues, and provide motivation. Risk Management: Identify and mitigate risks to project delivery and quality, and propose solutions. Other CDISC Requirements: Perform statistical team lead role within a compound, prioritize and gain efficiencies across protocols. Study Start-Up: Assist with protocol development, sample size calculation, and CRF review. Protocol: Author or QC review the statistical section of a protocol, utilizing organizational resources. Proposals: Review and comment on proposals/budgets, contribute to RFPs, and present at bid defenses. Clinical Study Report (CSR): Review or draft CSR or statistical reports. Customer Interaction: Serve as primary point of contact for customers and consult on operational topics. Lock and Unblinding Process: Handle database lock and unblinding processes, participate in randomization teams, and serve as unblinded lead statistician. Other Responsibilities: Assist with cross-functional collaboration as defined by managers. Qualifications: Master's Degree in Biostatistics or related field with 7+ years of relevant experience required. Typically requires 7+ years of prior relevant experience.