Executive Director, Head of Statistical Programming Position Available In Norfolk, Massachusetts

Overview The Executive Director, Head of Statistical Programming will have responsibility and accountability of statistical programming activities related to all stages of development for one or multiple therapeutic areas including the clinical-related components of regulatory submissions, either Clinical Trial Applications or New Drug Applications, to Post-marketing activities. This position will represent clinical statistical programming group on the clinical and project teams across the company’s portfolio, providing subject matter expertise to the clinical program. The position is expected to provide oversight and supervision of internal and external personnel to provide high quality programming support. This position reports to the head of Biostatistics and Data Management and can be at Needham, MA location. Responsibilities Key responsibilities of this role include but are not limited to: Ensure that the department has a well-organized programming infrastructure, standard operating procedures and adequate programming resources to enable projects to be completed on time and within budget. Provide leadership in balancing conflicting programming priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company’s strategic objectives Undertake the full range of duties relevant to the leadership, management and development of the programming team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives. Ensure programming training and onboarding plans in place and appropriate. Mentor, train, and guide statistical programming team. Provide performance review and feedback for team members. Act as the statistical programming representative in multidisciplinary project teams, work collaboratively with Clinical, Clinical Operation, Data Management, Pharmacovigilance, Regulatory, Project Management, Translational Medicine, Pharmacokinetics and other functions to meet project milestones and timelines to facilitate decision-making and address business needs Accountable for the quality of internal statistical programming deliverables including but not limited to analyses for regulatory agencies or any other internal and external ad-hoc requests. Ensure compliance with statistical programming SOPs and completion of documentation of all programming activities. Responsible for building relationships between Celldex Therapeutics and Partner(s)/Vendor(s)/CRO(s),and effectively interact and influence internal and external teams of all levels. This role supervises and is accountable for ensuring quality and timelines of Partner(s)/Vendor(s)/CRO(s) project deliverables and timelines as well as applying critical thinking and problem-solving in a high volume, fast-paced environment. Work with biostatistics and other function(s) for the development and optimization/standardization of the programming processes, the data review and reporting tools, and any other statistical applications as appropriate Maintain a positive, solutions-orientated work environment, build partnerships and model teamwork, communicate with the team in an open, balanced and objective manner. Perform vendor qualifications in regard to statistical programming function and manage CROs regarding programming issues and activities to ensure on time deliverables within budget. Qualifications Bachelor’s or Master’s Degree in Statistics, Biostatistics, Mathematics, Computer Science or related fields. Minimum 15 years of statistical programming experience in CRO, biotech, or pharmaceutical industry with at least 5 years’ programming leadership experience. Submission experience is required. Experience with immunology studies is preferred. Proven success record of working in a global matrixed environment and regularly collaborating with cross-functional teams, such as clinical trial operations, biometrics, IT, business-led technology organizations, and external vendors. Proven success record in managing timely and high-quality Electronic Submission deliverables for regulatory agencies. Solid extensive experience in an outsourced model and vendor management In-depth knowledge of EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical terminology, medical coding dictionaries, and quality control processes, as well as industry standards for electronic submission of data to FDA. Advanced knowledge in

GCP, ICH, GCP/ICH

standards, 21 CFR Part 11 and FDA/EMA requirements. Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages. Strong leadership, interpersonal, organizational, and multi-tasking skills, and ability to work within cross functional teams. Ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment. Ability to apply technical knowledge to work activities and use critical thinking skills for problem identification and solving; ability to prioritize and effectively manage multiple projects simultaneously. Excellent written and oral communication skills. 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.