Cellectis · 4 months ago
Senior Director, Biostatistics
New York, NY
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$220K/yr - $240K/yr
15+ years expCellectis is a leader in the biopharmaceutical industry, seeking a Senior Director of Biostatistics to oversee the development and execution of biostatistical strategies for clinical trials. The role involves managing CRO partnerships, ensuring data integrity, and collaborating with company leaders to meet strategic objectives in clinical development.
BiopharmaBiotechnologyHealth CareMedicalOncology
Responsibilities
In collaboration with the company leaders, create and implement development strategies consistent with the company’s strategic objectives
In collaboration with functional leads, ensure that the design of clinical trials and overall development plans are strategic, creative and meet requirements of global regulatory authorities with a high probability of technical success
In collaboration with functional leads, ensure that the execution of clinical trials, (specifically data capture, cleaning) delivers quality and timely ongoing and final databases, develop strategies to minimize the cost of clinical trial execution in delivering quality clinical trial data and ensure that clinical trial systems used in the running of clinical trials are effectively linked to avoid conflicting information
Effectively and efficiently manage CRO partners in the execution of statistical aspects of ongoing and planned clinical trials
Partner with member of study management teams and clinical science teams
Ensure the overall effective operations of the biostatistics, clinical data management, and clinical/statistical programming
Provide expert drug development advice to teams and development leaders
Establish a company environment that benefits from biostatics and quantitative sciences as strategic contributors in making assessments and decisions
Oversee and build the biometrics function, ensuring systems, capabilities, and resources are in place (both internal and external) to optimize the design, collection, analysis, and interpretation of data for each program consistent with the company’s strategic objectives
Develop and implement the statistical and data management specific standards, processes, SOPs, training and quality control for oversight of the biometrics activities in compliance with ICH and GCP in support of an internal and external resourcing model
Support the Regulatory head in interacting with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development
Partner with company leaders in building critical trial execution processes within and across functions to ensure GCP readiness and establish standards for teams to follow
Accountable and responsible for external biostatistics and program deliverables for CSRs and submission documents from CROs
Responsible for ensuring that the biostatisticians design and generate analyses in support of early phase studies as well as for abstracts and publications
Interact with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development
Qualification
Required
Masters in Statistics or Data Sciences preferred
Minimum 15 years of experience in leading biostatistics in clinical research (at various levels and in different capacities), including having built the biostatistics function and 5 years managing a biostatistical group working on all phases of clinical research and drug development
Experience with an NDA/EMA filing supporting US as well as international trials
Extensive experience in pharmaceutical or biotech companies determining appropriate designs, understanding the science and clinical application and analyses for clinical trials
Demonstrated experience building and managing a biostatistics team as well as using and managing outside consultants/CRO's a must, including proficiency in project planning and management and proactively anticipate and identify complex issues and problems
Demonstrated high level of technical skill and expertise as pertains to biostatistics, and programming, with an understanding of data management and data flow
Demonstrated excellent decision-making abilities with competency in making decisions and resolving problems
Successful track record of the management of clinical studies, from Phase I – III in support of US NDA filings
Proven track record communicating and leading the Biometrics discussions with the FDA, EMEA and other Global Health Authorities
Knowledge of GCP, ICH, and other Guidance documents and policies related to clinical trials operations requirements
Broad therapeutic understanding
Thorough knowledge of pharmaceutical and regulatory requirements, procedures, and policies
Exceptional interpersonal skills and written and verbal communication ability with demonstrated fluency in written and spoken English
Ability to make high level decisions and work with others as a team
Ability to travel up to 20%
Company
Cellectis
Cellectis is a biopharmaceutical company that develops adoptive immunotherapies for cancer.
51-200 employees
H1B Sponsorship
Cellectis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$393.48MKey Investors
European Investment BankAstraZeneca
2024-12-10Post Ipo Debt· $5.27M
2023-11-01Post Ipo Equity· $140M
2023-02-07Post Ipo Equity· $24.35M
Leadership Team
A
Arthur Stril
Chief Financial Officer & Chief Business Officer
Recent News
2026-01-06
2025-12-16
Company data provided by crunchbase