Associate Director, Biostatistics

Iovance Biotherapeutics, Inc.; Mississippi; On-site; USD 130,000 - 180,000; Full time

Job summary

A leading company in cell therapy seeks an Associate Director of Biostatistics to oversee complex oncology studies. The role demands a significant level of expertise in statistical analysis and requires effective leadership to meet the project needs while maintaining stringent quality controls. The ideal candidate will possess a strong educational background in biostatistics and extensive industry experience, particularly in oncology clinical trials.

Qualifications

• 8+ years industry experience with Master's or 5 years with a Ph.D.
• Oncology experience required.
• Experience with FDA regulations, NDA or BLA preferred.

Responsibilities

• Leads complex studies in oncology, providing statistical input.
• Ensures project timelines and quality control.
• Maintains understanding of global trends in biostatistics.

Skills

Theoretical statistics

Applied statistics

Survival analysis

Health economics

Programming in SAS

Decision-making

Education

Master’s degree

Ph.D.

Job description

Associate Director, Biostatistics leads very complex studies for cell therapies in oncology in study design, data analysis and interpretation of results independently with minimal supervision. This position provides statistical input to entire drug development plan and interacts with project teams and contract research organization (CRO) programmers.

Essential Functions and Responsibilities

• Ensures that biostatisticians and statistical programmers meet project needs according to timelines, with appropriate quality and budget control, based on company priorities.
• Accountable for technical review of functional deliverables, including clinical study protocols, statistical analysis plans, final study reports, and publications including abstracts and posters.
• Responsible for maintaining a broad understanding of relevant external global trends, anticipating emerging issues relevant to the clinical biostatistics function, identifying strategic needs in technical knowledge, fostering innovation, and aligning the strategic direction and execution plan for the function with business needs.
• Participates in due-diligence assessments and integration activities for business development opportunities.
• Creates networks with external statistical and programming collaborators and influences internal decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with corporate strategic interests.
• Accountable for identifying functional process needs, developing operating procedures, and ensuring technical training and regulatory compliance of staff.
• Engages cross-functionally to optimize collaboration, resolve cross-functional operational challenges, and leverage resources efficiently
• Invests in the Biostatistics & Statistical Programming team culture and environment to build high morale and commitment to company, team and individual goals and objectives.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Required Education, Skills, and Knowledge

• 8+ years of relevant industry experience with a Master’s degree or 5 years of industry experience with a Ph.D.
• Oncology experience a must.
• Sound knowledge of theoretical and applied statistics, including survival analysis methods, analyses on patient-reported outcome, and health economics.
• Experience with design and analysis of oncology clinical trials.
• Effective decision-maker who considers cross-functional and global perspectives, and applies knowledge, detailed analysis, seasoned experience, and sound judgment in making decisions that may involve limited or ambiguous information.
• Experience with FDA regulations and NDA or BLA preferred
• Strong verbal, written, and presentation skills.
• Demonstrated ability and experience in leading collaborative efforts to obtain and analyze complex data.
• Effective programming skills in SAS

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

#LI-remote

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

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