The Contract Associate Director of Biostatistics will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and 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 analysis, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.

Key Responsibilities
•    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. 
•    Author and develop SOPs, 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; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ? Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
•    CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines
•    Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities
•    Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analysis 
•    Other duties as assigned


Ideal Candidate
•    MS Degree in Biostatistics, Statistics, or a related field with 6+ 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.
•    Experience with regulatory submissions and interactions with regulatory agencies.
•    Proficiency in statistical software (e.g., SAS, R) and data management systems.
•    Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.
•    Excellent interpersonal communication skills, along with organizational skills.
•    Excellent communication and interpersonal skills.
•    Ability to work collaboratively in a multidisciplinary team environment.