Performs scientific oversight over multiple complex projects. 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 for drug or device development planning. Serves as Principal Investigator on government research grants contracts or cooperative agreements. Maintains expertise in state-of-the-art data manipulations and statistical analyses. Provides statistical leadership for corporate and departmental initiatives. Actively advances the companies standing in the wider pharmaceutical industry with regards to statistical innovation and capabilities. 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.
Essential Functions and Other Job Information:
Essential Functions Provides technical expertise and guidance in the development of protocols analysis plans programming specifications interpretation and writing of results Acts as a senior reviewer Leads the development and delivery of technical training for the department and the wider company community.
Mentors statistical scientists on theory and application of complex statistical analyses and consulting.
Acts as a resource regarding analysis plan writing programming and interpretation of results for areas of expertise in statistical methodology. Communicates with clients in a statistical sciences leadership role and provides expert biostatistical consultation.
Engages in training and professional development manuscript writing and presentations at statistical meetings.
Aids departmental management in process improvement and scientific strategies Suggests assesses and provides leadership in the department for such initiatives Provides statistical support and leadership to global corporate initiatives and leads efforts on working groups.
Guides statistical scientists and other team leaders in preparing major grant applications and proposals Reviews statistical aspects of proposals for completeness scientific merit and accuracy Independently organizes leads or anticipates in business development presentations.
May act as a lead statistician project lead or project manager on large projects andor development programs Oversees the scientific work of statisticians andor other departments working on protocols under the same NDAprogram Provides technical expertise and guidance in the development of protocols analysis plans programming specifications interpretation and writing of results.
Acts as lead statistical consultant for consulting projects and to project teams on complex and novel statistical methodology.
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.
Provides expert knowledge and experience of complex trials design across different therapeutic areas.
Provides input to management as to hiring recommendations department policies and resourcing requirements for statistical science staff.
Contributes to the identification and development of department documents or policies input into SOPWPD development and revision and training of new employees.
Acts as the representative of the department to other divisions and to the larger statistical Pharmaceutical CRO environment.
Job Complexity
Develops solutions to highly complex and unique issues that impact and address future concepts products or technologies.
Job Knowledge
As an expert in the field uses professional concepts in developing resolution to critical issues and broad design matters. Normally requires nomination and top management review and approval at this level.
Qualifications Education and Experience
Previous experience that provides the knowledge skills and abilities to perform the job comparable to 12 years AND Masters degree in statistics biostatistics or equivalent field with appropriate statistical coursework and 13 years of clinical trial experience as a statistician OR PHD in statistics biostatistics or equivalent field with appropriate statistical coursework and 11 years of clinical trial experience as a statistician.
Knowledge Skills and Abilities
Demonstrated initiative and motivation
Superior verbal and written communication skills including proficiency in the English language
Positive attitude and the ability to work well with others in a multidisciplinary setting Mastery of SAS and clinical biostatistics
Broad understanding of the drug development process
Conversant knowledge of FDA and other Regulatory guidance 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
Extensive organizational skills with the ability to adapt and adjust to changing priorities
Excellent 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 multidisciplinary setting Proficient in one or more therapeutic areas
Management role
No management responsibility
Working Conditions and Environment
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 Physical Requirements.
Ability to work in an upright and or stationary position for 6 to 8 hours per day Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the finger's hands and wrists
Frequent mobility required Occasional crouching stooping with frequent 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 1520 lbs.
Ability to access and use a variety of computer software developed both inhouse 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 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 multitask Regular and consistent attendance
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