Lead Biostatistician - FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Location/Division Specific Information

Our client a global mid-sized biotech company focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing international organization has a strong scientific foundation. If youre looking for a place where your work in partnership with others can have real impactand where youre encouraged to challenge yourself and contribute to breakthrough solutions the Lead Biostatistician could be a great fit.

Please note that candidates must be East-coast based in the United States with flexibility to travel. Extensive study design and sponsor experience required.

Your role:

• You contribute with your statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program.
• You will closely collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials and contribute to HA submissions
• You will report to a franchise team leader within the Biostatistics and Statistical Modelling organisation
• You will carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements

Desired Skills Qualifications and Experience:

• You have a master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 5 years experience (which may include doctoral research in field of biostatistics)
• You have expertise in drug development with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
• Demonstrates ability to plan supervise implement and monitor the statistical processes for multiple clinical trials
• You are proficient in statistical software (SAS and/or R);
• You are able to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
• You can clearly explain complex statistical concepts in written and spoken English
• You are a team-player with focused attitude
• You are able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast growing biotech company with challenging timelines

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
• Frequent mobility required.
• Occasional crouching stooping bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.