Find & Apply For Biostatistics Manager / Director Jobs in Needham, Massachusetts

Overview This role at Celldex Therapeutics is a senior-level leadership position focused on overseeing the end-to-end statistical programming lifecycle. It combines technical oversight, project management, and cross-functional collaboration to ensure clinical trial data meets rigorous regulatory standards. Responsibilities Lead or Co-ordinate statistical programming activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. Comply with company, department and industry standards (e.g. CDISC) and processes, responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Oversee the creation of CDISC compliant submission readiness output including but not limited to datasets (SDTM, ADaM), Tables, Listings and Figures (TFLs) and associated Define packages. Oversee the external programming activities outsourced to CROs to ensure the quality including standard programming practice, validation, and documentation. Build and maintain effective working relationships with cross-functional teams both internally and externally, contribute to the status of deliverables and critical programming aspects (timelines, scope, resource plan etc.) Support all in-house programming activities, if needed, including but not limited to regulatory filings, adhoc analysis, publication requests etc. Qualifications MS in Statistics or related field 8+ years of SAS programming experience in the biotech/pharma industry Experience as the lead programmer coordinating programming teams to support multiple regulatory submissions Experience managing people and projects. Proficiency with SAS Base, Macro, SQL, and Graph; working knowledge of R is a plus. Experience working with and managing external CROs or FSPs for programming deliverables. Familiarity with CDISC (SDTM/ADaM) standards and ability to adapt them for non-interventional data structures. Excellent communication skills and ability to work cross-functionally in a lean team environment. Compensation Statement The expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.