Senior Director, Biostatistics Lead

Alfasigma

3d•Hybrid

About The Position

Alfasigma is a global healthcare company with a focus on Gastrointestinal (GI) health, seeking a Senior Director, Biostatistics Lead. This role is responsible for biostatistics throughout clinical development, ensuring high-quality, timely, and cost-effective studies. The position involves strategic planning and execution of biostatistics activities, providing input on clinical development plans, protocols, reports, and regulatory submissions. The role also requires collaboration with other leaders in the biometric sciences department for harmonization, standardization, technology improvements, CRO oversight, and budget management. The Senior Director will represent biostatistics on clinical development teams and contribute to the company's overall product strategy.

Requirements

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 regarding 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, a strong sense of urgency, keen attention to detail, and the ability to successfully execute 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.
Ability to have fun and thrive in a growing, diverse, and inclusive work environment.
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.
Understanding of the company’s products, the competition, and the pharmaceutical industry in general.
Maintains current awareness of new drug developments in the business.

Nice To Haves

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

Responsibilities

Assume accountability for biostatistical components of regulatory submissions and ensure compliance with regulatory requirements.
Provide biostatistics subject matter expertise to clinical development teams and liaise with non-clinical and pre-clinical teams.
Lead and supervise a biostatistics team, managing performance, development, and succession planning.
Facilitate communication between biostatistics and cross-functional areas (e.g., Clinical Development, Data Management, Regulatory Operations).
Provide executive oversight of outsourced biostatistics activities, ensuring quality, compliance, and timeliness through vendor governance.
Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning.
Lead the development and optimization of biostatistical SOPs and templates, focusing on efficiency and quality.
Establish and maintain external relationships within the biostatistics community.
Develop and maintain a culture of innovation in study design, analytic methods, and execution.
Define, drive, and prepare statistical contributions to regulatory/submission strategy and related documents.
Understand the compliance environment and drive collaboration with the compliance team, maintaining inspection readiness.
Drive a collaborative team approach focused on patients.