Senior Director, Biostatistics

Cellectis; New York (NY); On-site; USD 220,000 - 240,000; Full time

Job summary

A biopharmaceutical company in New York seeks a Senior Director of Biostatistics. The role involves overseeing biostatistical strategies and operations for clinical trials while ensuring high data integrity. Candidates should have at least 15 years of relevant experience, including managing teams and interfacing with regulatory bodies. The compensation ranges from $220,000 to $240,000 depending on experience.

Qualifications

• Minimum 15 years of experience in leading biostatistics in clinical research.
• Experience with NDA/EMA filing supporting US and international trials.
• Demonstrated experience building and managing a biostatistics team.

Responsibilities

• Create and implement development strategies aligned with company objectives.
• Ensure quality and timely execution of clinical trials data capture.
• Manage CRO partners in statistical execution of trials.
• Interact with FDA and regulatory authorities.

Skills

Leadership in biostatistics

Data integrity and quality assurance

Communication with regulatory bodies

Clinical trial management

Project planning and management

Education

Masters in Statistics or Data Sciences

Job description

1 day ago Be among the first 25 applicants

JOB DESCRIPTION

The Senior Director, Statistics will be in charge of the development and oversight of biostatistics and statistical/clinical programming strategies, operations, and personnel to ensure the efficient, accurate and timely collection and analysis of clinical trial data while ensuring high standards of data integrity and quality. The Senior Director Biostatistics will partner with other company leaders to design and implement clinical development plans, and overall development strategy for Cellectis’ programs and products. The incumbent will manage and direct CRO partners and leverage the capabilities of these partners. This role is an experienced leader comfortable liaising with senior levels of management both within and external to the organization.

Position Summary

JOB DESCRIPTION

The Senior Director, Statistics will be in charge of the development and oversight of biostatistics and statistical/clinical programming strategies, operations, and personnel to ensure the efficient, accurate and timely collection and analysis of clinical trial data while ensuring high standards of data integrity and quality. The Senior Director Biostatistics will partner with other company leaders to design and implement clinical development plans, and overall development strategy for Cellectis’ programs and products. The incumbent will manage and direct CRO partners and leverage the capabilities of these partners. This role is an experienced leader comfortable liaising with senior levels of management both within and external to the organization.

Position 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
  
  

Education And Experience

• 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
• xtensive 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
  
  

CORE COMPETENCIES

• 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%
  
  

Physical Requirements

• Sedentary - primarily involves sitting and/or standing.
• Communicates with others on a daily basis to exchange information.
  
  

Anticipated compensation, DOE, $220,000 - $240,000

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

Referrals increase your chances of interviewing at Cellectis by 2x

Get notified about new Director Biostatistics jobs in New York, NY.

New York, NY $169,700.00-$282,900.00 3 days ago

Director, Data Science/Advanced Analytics - VP

New York, NY $160,000.00-$220,000.00 2 weeks ago

East Hanover, NJ $185,500.00-$344,500.00 1 week ago

East Hanover, NJ $185,500.00-$344,500.00 2 weeks ago

New York, NY $225,000.00-$305,000.00 5 days ago

New York, NY $253,000.00-$314,000.00 6 days ago

New York, NY $262,000.00-$340,000.00 2 weeks ago

New York, NY $169,700.00-$282,900.00 9 hours ago

New York, NY $262,000.00-$340,000.00 2 weeks ago

New York, NY $132,715.00-$208,840.00 1 day ago

New York, NY $132,715.00-$208,840.00 2 days ago

New York, NY $220,000.00-$390,000.00 6 days ago

Associate Director, Commercial Analytics and Data Science

New York, NY $171,000.00-$185,000.00 3 weeks ago

East Hanover, NJ $194,600.00-$312,400.00 2 weeks ago

New York, NY $170,000.00-$200,000.00 19 hours ago

New York, NY $132,715.00-$208,840.00 19 hours ago

Medical Director, Clinical Development, NGN-401

Director, Early Clinical Development - Immunology

East Hanover, NJ $204,400.00-$379,600.00 1 week ago

(Senior) Clinical Development Medical Director

East Hanover, NJ $236,400.00-$439,600.00 2 weeks ago

(Senior) Clinical Development Medical Director

East Hanover, NJ $236,400.00-$439,600.00 1 week ago

Clinical Development Medical Director, Neuroscience

East Hanover, NJ $257,600.00-$386,400.00 2 weeks ago

Clinical Development Program Lead, Neuropsychiatry (Executive Director)

(Senior) Clinical Development Medical Director

East Hanover, NJ $236,400.00-$439,600.00 6 days ago

East Hanover, NJ $152,600.00-$283,400.00 2 weeks ago

Medical Director, Clinical Development, GynOnc

Associate Clinical Development Medical Director

East Hanover, NJ $204,600.00-$379,400.00 1 week ago

Senior Clinical Development Medical Director, Oncology Nuclear Medicine (MD)

East Hanover, NJ $236,600.00-$439,400.00 1 week ago

Clinical Development Medical Director (CDMD)

East Hanover, NJ $240.00-$240.00 2 weeks ago

Clinical Development Medical Director, Oncology Nuclear Medicine (MD)

East Hanover, NJ $236,600.00-$439,400.00 1 week ago

Senior Clinical Development Director - Renal

East Hanover, NJ $204,400.00-$379,600.00 2 weeks ago

Clinical Development Medical Director - Cardiovascular & Metabolic

East Hanover, NJ $236,400.00-$439,600.00 3 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.