Senior Director, Biostatistics

Role Description

The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including:

• Contributing to trial designs
• Authoring statistical sections of protocols
• Preparing statistical analysis plans
• Reviewing and interpreting the analysis of clinical trial data

This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.

Qualifications

• PhD Degree in Biostatistics, Statistics, or a related field
• At least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry
• Strong knowledge of statistical methodologies and their application in clinical trials and health research
• Working knowledge of Bayesian methodology is preferred
• Experience with regulatory submissions and interactions with regulatory agencies
• Proficiency in statistical software (e.g., SAS, R) and data management systems
• Experience with CDSIC including SDTM, ADaM, CDASH
• Successful track record of working independently in a matrixed organization
• Excellent communication and interpersonal skills
• Ability to work collaboratively in a multidisciplinary team environment

Requirements

• Lead the biometrics team including statistician, data manager, and statistical programmer at a program level
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies
• Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies
• Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings
• Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data
• Participate in cross-functional study-related activities
• CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines
• Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally
• Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses
• Build and develop efficient biostatistical processes and standards, when appropriate

Benefits

• Opportunity to work in a fast-paced, dynamic environment
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each year
• Commitment to provide professional development opportunities
• Remote working environment with frequent in-person meetings
• The expected salary range offer for this role is $275,000 to $290,000