Associate Director, Biostatistics

Position Summary

The Associate Director of Biostatistics is a member of a cross-functional clinical development team and contributes to clinical trial design, study protocol development, statistical analysis planning, interpretation of results, preparation of regulatory submissions and publications. This position will work collaboratively with data management, statistical programming, external partners, medical director(s), clinical scientists, clinical study managers, project managers, PK scientists, and other members of the study team.

Essential Functions

• Leads the development and execution of all statistical aspects for clinical trials, including contribution to clinical trial design, statistical analysis planning, study results presentation and interpretation, clinical study report, regulatory documents (IND submissions, briefing package, DSURs, etc.), regulatory submissions, and publications. 
• Accountable for ensuring quality in planning, design and execution of assignments associated with the assigned projects.
• Contributes to clinical study designs and strategic discussions around the clinical development plan.
• Performs statistical simulation and / or power calculations to determine the appropriate sample size for a clinical trial.
• Authors statistical and sample size sections in developing clinical study protocols.
• Collaborates with Data Management and other members of the study team on the design or modification of the eCRFs.
• Provides vendor management and oversight and ensure quality in CRO deliverables such as statistical analysis plan and TFLs.
• Participates in meetings with regulatory authorities (FDA, EMA, etc.) as necessary.
• Contributes to scientific presentations and manuscripts for publications, summarizing data collected in clinical trials, or analyzing external data.
• Involved in Data Science’s standard operating process development. 

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.

Qualifications

Education & Experience

• Ph.D. in statistics, biostatistics, mathematics, or related quantitative field with 7 or more years of experience in biopharmaceutical /CROs; or MS in statistics with 10 or more years of experience in biopharmaceutical/ CROs. 
• Understanding of ICH GCP and good knowledge of industry practices and standards as related to biostatistics and clinical trials.
• Extensive knowledge of statistical methodology and data analytic methods used in clinical trials.
• Knowledge or experience in adaptive designs or innovative statistical methodology in the clinical, and regulatory environments.
• Statistical computing and simulation skills with proficiency in one or more programming languages such SAS and R.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH standards. 
• Excellent verbal and written communications skills, including the ability to clearly articulate statistical concepts to non-statisticians. 
• Ability to engage effectively as a team player within a team working environment.
• Ability to be flexible and adapt quickly to the changing needs of the organization.

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.