Senior Director, Biostatistics at Top Employer

Job Description

Connect With Us

[**Our Mission: Transform Lives Through Innovation.**]

At [Top Employer], we are driven by a profound commitment to discover, develop, and deliver life-changing medicines for patients with unmet medical needs. Our patient-centric approach fuels our innovation, and we are seeking a visionary leader to join our dynamic team and significantly contribute to our groundbreaking work.

Job Overview

[Top Employer] is seeking an exceptional and experienced Senior Director, Biostatistics to lead and shape our biostatistical strategy and execution across multiple critical drug development programs. This pivotal role will oversee a team of talented biostatisticians, ensuring the rigorous application of statistical principles to the design, analysis, and interpretation of clinical trials. You will collaborate closely with cross-functional teams, including clinical operations, regulatory affairs, and data management, to deliver high-quality statistical deliverables that support regulatory submissions and inform critical decision-making.

Key Responsibilities

* Lead and manage a team of biostatisticians, fostering a culture of scientific excellence, collaboration, and professional development.
* Provide strategic statistical input for clinical trial design, protocol development, and statistical analysis plans for Phase I-IV studies.
* Oversee the development and execution of statistical analysis plans, ensuring the integrity and validity of data analysis.
* Author and review statistical sections of regulatory submission documents (e.g., INDs, NDAs, BLAs) and publications.
* Serve as the primary statistical liaison for regulatory agencies, presenting and defending statistical approaches and results.
* Collaborate with clinical teams to interpret study results and ensure appropriate conclusions are drawn.
* Stay abreast of evolving statistical methodologies, regulatory guidelines, and industry best practices, and champion their adoption within the organization.
* Contribute to the development and implementation of statistical tools, standards, and processes to enhance efficiency and quality.

Requirements

* Ph.D. or Master’s degree in Biostatistics, Statistics, or a related quantitative field.
* Minimum of 10 years of progressive experience in biostatistics within the pharmaceutical or biotechnology industry, with a strong focus on clinical development.
* Demonstrated leadership experience, including managing and mentoring a team of biostatisticians.
* Extensive experience with statistical analysis of clinical trial data, including the use of SAS or R for statistical programming.
* In-depth knowledge of ICH guidelines, regulatory requirements, and statistical principles relevant to drug development.
* Proven track record of successfully contributing to regulatory submissions and supporting data interpretation for decision-making.
* Excellent communication, interpersonal, and presentation skills, with the ability to clearly articulate complex statistical concepts to diverse audiences.

What We Offer

* The opportunity to lead impactful biostatistical work at a leading global biopharmaceutical company dedicated to patient well-being.
* A collaborative and innovative work environment that encourages scientific curiosity and professional growth.
* Competitive compensation and comprehensive benefits package designed to support your overall health and financial security.
* The flexibility of a fully remote work arrangement, allowing you to contribute effectively from anywhere.