To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education/Experience: The ideal candidate will offer:
- A PhD in statistics, biostatistics, or related field with 6+ years of clinical drug/biologic development experience in regulated industry and 2+ years of management experience or project management experience with statistical deliverables
- A MS in statistics, biostatistics, or related field with 10+ years of clinical drug/biologic development experience in regulated industry and 2+ years of management experience or project management experience with statistical deliverables
- Demonstrated understanding of the drug development process with clinical trial design, study implementation, statistical methodology, and regulatory requirements pertaining to statistics and data standards for human clinical studies
- Familiarity with the implementation of FDA, GCP, ICH, and PhRMA guidelines as they relate to statistics
- Familiarity with relevant FDA regulations and demonstrated experience in responding to written FDA questions
- Experience with preparations of NDAs and/or BLAs
Desirable Knowledge, Skills and Abilities:
- Experience with drug development in oncology and/or inborn errors of metabolism
- Knowledge of EU, Canada, and/or Japan regulations and experience with written submissions/responses to regulatory agencies in addition to FDA
- Experience with preparation for, and speaking for, a pharma/biotech company at advisory committee meetings, labeling negotiations, and other regulatory interactions
- Strong communication (oral and written), presentation, and analytical skills
- Ability to work independently, prioritize tasks efficiently, and meet expected timelines
- Ability to interact collaboratively with colleagues, investigators, key opinion leaders, and regulators
- Experience building strong teams
- Experience with statistical analysis software such as SAS, experience with electronic data capture platforms such as Medidata Rave, experience with MedDRA and WHODRUG dictionaries
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally on occasion is required, it is anticipated that this will be less than 30% of work time.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Light physical activity performing non-strenuous daily activities of an administrative nature. Including but not limited to: Sitting for greater than 75% of your time, standing and walking for up to 25% of your time. Manual dexterity sufficient to reach/handle items and work with the fingers. Use of hands to fingers for typing and other computer activity for up to 75% of your time. Reaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your time. Ability to lift, up to 25lbs, less than 25% of the time.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.