Sr. Biostatistician-REMOTE

POSITION SUMMARY:

The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and programming external vendors. Essential Functions: Provide timely and scientifically sound statistical expertise to clinical development projects. Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. Collaborate with members of project teams to establish project timelines and to develop and implement protocols Work closely with data management, clinical operations, programming, and other biostatisticians to develop and validate study-specific data capture systems Develop statistical analysis plans (SAPs) to meet regulatory standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation. Produces table, figure, and listing templates for reporting of study results and data. Coordinates data and table review activities among the project team members. Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes. Reviews study protocols, CRFs, Data Validation Specifications (DVS), and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data. Writes specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; performs validation of key statistical results. Analyzes clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output. Develops templates for ISS and ISE statistical tables for regulatory submission in conjunction with clinical, and provides specs and supervision for production of ISS and ISE tables. Reviews ISS and ISE reports towards regulatory submission. Performs statistical analysis for publication. Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and works closely with Medical Writing in study report preparation. Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables. Participate in CRO selection process. Responds to questions from the FDA and other regulatory authorities on statistical issues. Attend regulatory meetings to support and defend clinical programs. Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data. Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc. Communicates with Project Managers regarding resourcing to assure the appropriate staff is assigned to each study. Provides input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations). Train and mentor new statisticians. Other duties as assigned. Qualifications: PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with a minimum of six (6) years of relevant work experience Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics Familiarity with pharamcokinetic/pharmacodynamic data, a plus Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) a plus Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines. Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff.

REQUIRED KNOWLEDGE AND ABILITIES:

Knowledge of CDISC requirements for SDTM and ADaM Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required. Exceptional interpersonal skills and problem solving capabilities.