Vice President, Biostats and Data Management (Biotech)

Description

Position Summary

The role of head of Biostatistics and Data Management  is a leadership role responsible for the development and ongoing operation of the company's tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning and other algorithms.

At an exciting time of growth for our company with a significant number of ongoing and planned clinical trials supporting multiple investigational agents in the pipeline followed closely behind by new investigational agents from internal research platforms, the successful candidate who will be seen to be an inspirational leader will be responsible to oversee the Data Science organization .

Essential Functions

• Global lead for the development and execution of biostatistics, statistical programming, and data management strategies to support clinical development activities
• Oversee statistical leadership into the ongoing clinical trial programs and for development of new programs
• Provide input into drug development strategies along with Program level and Group level personnel.
• Support interactions with global health authorities, as well as with partner contract research organizations.
• Ensure quality and timeliness of statistical, programming and data management deliverables
• Responsible for the attestations of data integrity of clinical trials and accuracy of all statistical analyses across all development programs.
• Accountable for the accuracy of statistical proposals that are part of materials for health authority meetings
• Provide biometrics consultations to Business Development, Medical Affairs, HEOR, and Research organizations as needed.
• Resource and support analytical activities that are included in plans for scientific publications with the publication and medical affairs teams.
• Member of the Global Clinical Development Leadership team 
• Continues to resource the Biometrics team with ongoing assessment of capability needs
• Mentors and develops members of the Biometrics organization
• Establish and ensure adherence to biostatistics and statistical programming best practices, SOPs, standards, and processes regarding the conduct of clinical trials, statistical methodology, data analyses and interpretation

Requirements

Qualifications

Education & Experience: 

• Doctoral degree in Biostatistics or Statistics is required
• 15 plus years in biotech and/or pharmaceutical industry in roles of increasing responsibilities related to biostatistics and data management.
• Demonstrated record of fostering creativity, productivity, and execution with urgency, teamwork and accountability.
• Team-builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives consistent with AnaptysBio culture
• Previous experience in managing multiple direct reports is a must and preferably if also had direct responsibility for areas not limited to biostatistics.
• Experience with multiple (s)NDAs, BLAs, and MAA’s is a must, and preferred if experience with J-NDA submissions and reviews.
• Ideally, has worked in more than one therapeutic area and has direct experience with innovative Phase 2 and 3 clinical study designs with the therapeutic areas of interest residing in rare or in uncommon disorders encompassing the development of small and large biological molecules.
• Comfort with model-based drug development and agile drug development is important
• Appreciation for observational methodologies is preferred
• Ability to articulate complex methodologies to senior executives for their understanding is required with previous experience with presenting to senior executives being ideal.

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.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

May be required to travel by plane or car.

This position requires working with biological and/or chemical hazards.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Salary : $269,000 - $347,000