- Contract Opportunity
- Work Remotely - Work from Home
- Position is available in the United States and Belgium
- Once travel restrictions are lifted, there will be travel to Boston, MA or Ghent, Belgium 1-2 times a month
- Serves as the scientific and therapeutic area thought leader for study design and statistical analysis issues. Serves as the project manager for contracts -both standalone and cross divisional. Provides scientific strategy consultation to clients and internal management for drug or device development planning. Maintains expertise in state-of-the-art data manipulations and statistical analyses. Serves as Principal Investigator on government research grants, contracts, or cooperative agreements. Provides statistical leadership for corporate and departmental initiatives. Represents the department to clients on complex study design matters, directly contributing to complex study proposals and bids, representing the department at bid defenses as required. Acts as the representative of the department to other divisions and acts as a representative of the department to the larger statistical Pharmaceutical/CRO environment.
- Serves as the lead statistician, project lead, project manager, and/or senior reviewer on large projects and/or development programs.
- Oversees the scientific work of statisticians and/or other departments working on protocols under the same NDA/program.
- Acts as consultant to internal project teams on complex and novel statistical methodology and as needed provides senior review on multiple projects.
- Provides technical expertise and guidance in the development of protocols, analysis plans, programming specifications, interpretation and writing of results.
- Acts as lead consultant for consulting projects and mentors statistical scientists to become effective consultants.
- Mentors statisticians on theory and application of complex statistical analyses.
- Acts as a resource regarding analysis plan writing, programming, and interpretation of results for areas of his/her expertise in statistical methodology.
- Engages in training and professional development, manuscript writing, and presentations at statistical meetings.
- Provides expertise and lead the development and delivery of technical training for the department and the wider company community.
- Provides expert knowledge within the company on statistical and regulatory issues and on select therapeutic areas.
- Aids departmental management in process improvement and scientific strategies.
- Suggests, assesses, and provides leadership in the department for such initiatives.
- Produces sample size calculations.
- Provides input into study design and statistical considerations, during protocol development.
- Reviews protocols for completeness, appropriateness of clinical design and sound statistical analysis.
- Contributes to writing appropriate protocol sections.
- Contributes to the development of company standard operating procedures (SOPs) and working practices (WPDs).
- Provides input to management as to hiring recommendations, department policies, and resourcing requirements.
- Assists in bidding and business development activities, as required.
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years').
- Master's degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and 6 years of clinical trial experience as a statistician;
- OR PH.D. in statistics, biostatistics, or equivalent field with appropriate statistical
coursework and 4 years of clinical trial experience as a statistician;
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Demonstrated initiative and motivation
- Excellent verbal and written communication skills, including proficiency in the English language
- Positive attitude and the ability to work well with others in a multi-disciplinary setting
- Mastery of SAS® and clinical biostatistics
- Broad understanding of the drug development process
- Conversant knowledge of FDA and other Regulatory guidances and regulations
- Capable of managing change and uncertainty to optimize positive outcomes
- Capable of multitasking and sharp attention to detail
- Evidence of strong management skills, as shown through the successful management of multiple projects and team members
- Outstanding organizational skills with the ability to adapt and adjust to changing priorities
- Strong theoretical background and applied statistical knowledge
- Capable of mentoring team members with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic area
- Capable of communicating complex statistical concepts in a multi-disciplinary setting
- Proficient in one or more therapeutic areas