Associate Director, Statistical Programming

About Us

We are a global, family-owned company driven by a passion for innovation. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. With

700+ employees across the UK, Ireland, the Nordics, Germany, and the USA,

we are committed to scientific excellence, patient care, and collaborative partnerships with the medical community. Our core values define who we are: People-Driven

– We are a family-held company built on passionate, knowledgeable people. We value integrity, open-mindedness and respect and are guided by these values in all our endeavors. We respect each individual who becomes a part of our journey, from our employees and partners to our end-users. And we recognize that the strength in all our collaborations is trust. Committed to Quality

– Quality is our source of inspiration. Quality drives our results. It represents our aspiration for excellence and our focus on driving continual improvements. For our partners and end-users, quality must always be tangible in our products, processes and people. This way, quality is the promise we keep every day. Innovating for Better Lives

– Innovation is essential in our quest to improve the lives of humans. We seek to address unmet needs through our expertise in iron and carbohydrate-based pharmaceuticals. We believe in a holistic and collaborative approach to research and innovation, so we work together with the scientific and medical communities to set new standards. We have continued our growth trajectory since we launched our first product in the US, Monoferric® (ferric derisomaltose), through acquisitions, partnerships, and pipeline. Our R&D investments continue to leverage our core competencies, alongside our recent advancements in oncology supportive care. Join us in shaping the future of patient care through innovation and collaboration. Job Purpose: To provide sponsor-side statistical programming expertise and oversight across Pharmacosmos clinical development programs, ensuring that clinical data, programming deliverables, submission datasets and associated documentation are GCP-compliant, regulatory-compliant, traceable, reproducible, inspection-ready and aligned with regulatory requirements. This role acts as the subject matter expert for CDISC standards, statistical programming processes and supporting sponsor oversight of outsourced programming activities. • Ensuring that CDISC standards are applied consistently to derived clinical trial datasets (SDTM and ADaM) and that dataset submission packages meet all applicable regulatory submission requirements. • Providing statistical programming support across clinical development activities, including contributions to SAP review, database build oversight, data cleaning activities, trial execution and regulatory submissions. • Supporting alignment between protocol objectives, data collection, statistical analyses and regulatory reporting requirements to ensure accurate, meaningful and decision-ready clinical trial outputs. • Performing ad hoc analyses, data reviews and exploratory data assessments to support internal decision-making and cross-functional project teams. • Providing sponsor oversight and quality review of outsourced statistical programming deliverables, ensuring high quality, regulatory compliance, data integrity, traceability and timely delivery. • Maintaining sponsor ownership of programming standards, metadata, documentation and reproducibility processes, ensuring that submitted analyses and datasets can be independently regenerated and defended during audits and regulatory inspections. • Working closely with Biostatistics, Data Management, Medical Writing, Clinical Science and Clinical Operations to support efficient trial execution and high-quality clinical development deliverables. Job Responsibilities: Review and contribute to key trial documents, including SAPs, CRFs, validation plans, SDTM and ADaM specifications, and supporting documentation, to promote completeness, consistency, and high quality. Ensure alignment between protocol objectives, data collection, SDTM/ADaM specifications and planned analyses to support meaningful, decision-ready and regulatory-compliant trial outputs. Provide sponsor oversight and risk-based quality review of outsourced statistical programming deliverables, ensuring data integrity, traceability, reproducibility and compliance with Pharmacosmos standards. Support inspection readiness by maintaining programming documentation, metadata, validation evidence and dataset traceability required for audits and regulatory inspections. Participate in cross-functional review of outsourced statistical deliverables, including SAPs, TLF shells, specifications, SDTM and ADaM datasets, Define-XML, and related documentation. Ensure that trial datasets, including SDTM and ADaM, comply with applicable CDISC standards and meet regulatory submission requirements. Maintain awareness of evolving industry data standards, best practices, regulatory expectations, and emerging technologies in statistical programming and data analysis. Provide programming support across clinical development, including summarized tabular and graphical analyses for publications, internal and external scientific meetings, and multidimensional clinical data analyses. Collaborate with biostatistics, data management, and clinical operations to align statistical analysis plans with data collection procedures. Provide programming support for integrated analyses and regulatory data submissions. Support the trial statistician in vendor management and oversight of statistical programming deliverables, as needed. Maintain sponsor ownership of programming standards, metadata and associated documentation, ensuring that key analyses and datasets can be independently reproduced and regenerated when required. Contribute to the evolution and implementation of departmental programming standards, validation practices and innovation initiatives. Policies, Procedures & Compliance: Stay current and in compliance both individually and as a department to align with industry best practices. This includes all Corporate Policies as well as mandated government Regulations. Ensure adherence to all relevant laws, regulations, and guidelines related to pharmaceutical operations, including FDA, EMA, and other global health authority regulations. Stay current with and adhere to all policies and procedures as outlined in the employee handbook. Education & Professional Background: Education: Bachelor or MSc (preferred) in Computer Science, Statistics, Mathematics, or a related quantitative field. Experience: Minimum of 10 years of statistical programming experience in the pharmaceutical or biotechnology industry, including experience supporting multiple clinical trials. Strong technical knowledge of CDISC standards and hands-on experience with SDTM, ADaM, and Define-XML. Comprehensive understanding of the drug development process, submission-related activities, and applicable regulatory requirements and guidelines, including CDISC, CDASH, eCTD, ICH, CHMP, FDA, and GCP. Proficiency in providing hands-on SAS programming support for production or validation of analysis datasets and TLFs. Thorough knowledge of SAS functionality, including Base SAS, ODS, SQL, Macro, and SAS/GRAPH, with proficiency in Microsoft Office applications. Familiarity with additional programming languages, such as R, Python, or Java, is considered an advantage. Competencies: Excellent analytical and problem-solving skills, with attention to detail and scientific integrity. Strong communication and interpersonal skills, capable of influencing across functions. Structured, proactive, and adaptable, thriving in a dynamic and evolving environment. Demonstrated commitment to quality, ethical standards, and continuous learning. Ability to work independently and deliver results on time. Attitude and Demeanor: Proud Pharmacosmos ambassador Strong personal leadership Inspire cross-functional transparency and collaboration Customer-centric ‘can-do’ attitude and goal focused Ambitious, independent, analytical, collaborative, loyal, organized Flexibility: Our roles can evolve over time. Reasonable flexibility is, therefore, a key part of any job at Pharmacosmos. Significant variations in duties and responsibilities should be discussed between the employee and manager. Additional information: Requires budgetary responsibilities and discretion with confidential data Travelling – approximately 5% of the time All job requirements listed indicate the minimum level of knowledge, skills and/or experience necessary to perform the job proficiently. This job description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Employees will be required to perform any other job-related duties as requested by their supervisor, subject to reasonable accommodation. Pharmacosmos Therapeutics Inc. is committed to equal opportunity in employment. We value diversity which embraces all perspectives towards innovation and are committed to making PTI a truly inclusive place to work where everyone of us can be our best and true selves. We select and employ qualified candidates in accordance with their competencies and skills to perform the duties of the job regardless of gender, gender identity or expression, ancestry, national or ethnic origin, marital status, race, religion, color, age, disability, sexual orientation, military, or veteran status. Pharmacosmos Therapeutics Inc. has adopted a hybrid work schedule – a combination of being on-site at our Morristown, NJ offices along with remote working. Being present is critical to collaboration, innovation, productivity, employee well-being and engagement and enhances the Company culture. #LI-Hybrid