: Purpose of the Job The 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.

The 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,

In 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.

Principal Accountabilities The Senior Director, Biostatistics Lead within the GBS, Biostatistics department, should be able to perform each of the following satisfactorily:

- Assume accountability for biostatistical components of regulatory submissions; ensure activities are conducted in compliance with relevant regulatory requirements.
- Provide 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.
- Lead 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.
- Facilitate 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.
- Provide 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.
- Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed.
- In 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.
- Establish and maintain external relationships with the biostatistics community, key opinion leaders and other external biostatistical consultants.
- Develop and maintain a culture of innovation in study design, analytic methods, and execution optimization.
- Define, 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.).
- Understand the compliance environment and drive collaboration with the compliance team. Maintain inspection readiness of all biostatistical deliverables.
- Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority.

Work Experience





- Extensive 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.
- Ability to lead a team with regards to ongoing development both personnel development and departmental methodologies and techniques.
- Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently; Able to work in a quickly changing matrix environment.
- Demonstrated 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.
- Proven excellence in biostatistics and clinical development plan strategy, operations, and execution.
- Learning agility and ‘scalability’ to take on increasing responsibility as Alfasigma grows.
- Ability to have fun and thrive in a growing, diverse, and inclusive work environment.

Education & Training

- PhD 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.
- 10 years of experience of direct management of internal and/or external biometrics team highly preferred.

Competencies & Major Skills

- Proficiency 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.)
- Knowledge of CDISC requirements for SDTM and ADaM.
- Strong verbal and written communications skills in English.
- Exceptional interpersonal skills and problem-solving capabilities.
- Requires understanding of the company’s products, the competition, and the pharmaceutical industry in general.
- Maintains current awareness of new drug developments in the business.

📌 Senior Director, Biostatistics Lead (Milano)
🏢 ALFASIGMA
📍 Milano