Senior Director, Biostatistics Lead

ppSelect how often (in days) to receive an alert: /p pAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. /p pOver three years ago, we embarked on a transformative journey to become ba truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health /b. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. /p pbBut our journey is far from complete! /b In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. /p pAs part of our journey, we are hiring a Senior Director, Biostatitistics Lead. This role can be based in Milan or in other EU countries. /p h3Purpose of the Job /h3 pThe Senior Director, Biostatistics Lead is responsible and accountable for biostatistics as it relates to all stages of clinical development for one or more therapeutic areas delivering clinical studies and research programs of the highest quality in a time and cost-effective manner. /p pThe Senior Director, Biostatistics Lead ensures the successful strategic planning and execution of all therapeutic area biostatistics activities using both internal and external resources. Provides input into clinical development plans, protocols, clinical study reports, regulatory submissions, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy. This position may represent biostatistics providing subject matter expertise on the clinical development teams across the company’s portfolio, /p pIn partnership with other leaders of the global biometric sciences department and the global Head of Biometric Sciences, the Senior Director, Biostatistics Lead, is expected to provide input for cross functional harmonization and standardization, technology and process improvement, CRO oversight and resource and budget forecasting and monitoring. /p h3Principal Accountabilities /h3 ul liAssume accountability for biostatistical components of regulatory submissions; ensure activities are conducted in compliance with relevant regulatory requirements. /li liProvide biostatistics subject matter expertise to the clinical development teams as appropriate; Liaise with non-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues. /li liLead and supervise an efficient and effective biostatistics team. Manage performance of direct reports, ensure development and succession planning. Provide coaching and feedback to foster professional development while also supporting business goals. /li liFacilitate and maintain communication between biostatistics and cross-functional areas to include Clinical Development, Clinical Operations, Data Management, Statistical Programming, Regulatory Operations, Pharmacovigilance, Translational Science, Medical Affairs, etc. translating strategic decisions into operational plans. /li liProvide executive oversight of outsourced biostatistics activities across clinical development programs, ensuring high-quality, compliant, and timely statistical deliverables through effective vendor governance for oversight, resource planning, budget management, and regulatory compliance. /li liContribute strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed. /li liIn partnership with key members of the GBS department, lead development and optimization of biostatistical related SOPs and templates with specific focus on efficiency and quality, while maintaining or exceeding industry’s best practices. Influence the broader organization with respect to innovation in clinical study design and/or analysis methods. /li liEstablish and maintain external relationships with the biostatistics community, key opinion leaders and other external biostatistical consultants. /li liDevelop and maintain a culture of innovation in study design, analytic methods, and execution optimization. /li liDefine, drive and prepare (or supervise preparation of) statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Briefing Books, NDA/CTD, Regulatory Responses, Advisory Committee preparation, etc.). /li liUnderstand the compliance environment and drive collaboration with the compliance team. Maintain inspection readiness of all biostatistical deliverables. /li liDrive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority. /li /ul h3Work Experience /h3 ul liExtensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the global drug development process. eCTD NDA submission experience is a must. /li liAbility to lead a team with regards to ongoing development both personnel development and departmental methodologies and techniques. /li liManage multiple programs with competing and aggressive timelines, prioritize activities, and work independently; Able to work in a quickly changing matrix environment. /li liDemonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures. /li liProven excellence in biostatistics and clinical development plan strategy, operations, and execution. /li liLearning agility and ‘scalability’ to take on increasing responsibility as Alfasigma grows. /li liAbility to have fun and thrive in a growing, diverse, and inclusive work environment. /li /ul h3Education Training /h3 ul liPhD degree in statistics or biostatistics with 15 years of relevant work experience in pharmaceutical industry OR a Master’s degree in statistics or biostatistics with 18 years plus of relevant pharmaceutical industry experience. /li li10 years of experience of direct management of internal and/or external biometrics team highly preferred. /li liProficiency with SAS statistical procedure and specialized relevant statistical software (e.g. EaST, R, S-Plus) as well as standard computing environment (Unix, Cloudbased computing, PC office software, etc.) /li liKnowledge of CDISC requirements for SDTM and ADaM. /li liStrong verbal and written communications skills in English. /li liExceptional interpersonal skills and problem-solving capabilities. /li liRequires understanding of the company’s products, the competition, and the pharmaceutical industry in general. /li liMaintains current awareness of new drug developments in the business. /li /ul h3Why Join Alfasigma: /h3 pbAt Alfasigma, we foster a culture where the courage to innovate is key to our success. /bbr/We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /p pOur commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. /p pbJoin Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry. /b /p /p #J-18808-Ljbffr