Biostatistician

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Job Summary Job Title:

Biostatistician (Medical Device)

Location:

Remote Duration:

Long Term PHD in Biostats + 1 - 3 years exp Masters in Biostats + 3 - 6 years exp

Position Summary:

The contract Biostatistician will be acting as an independent project-level statistician to support medical affairs/research, commercial, and safety. This role is responsible for statistical aspects of research questions, for coordinating the analysis, validation, and study documentation, and analyzing data for ad-hoc analyses (associated with pubs or adcomm prep) from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, market access, safety, medical writing and data management, clinical operations, and especially with programming, and will sometimes collaborate with external statistics and programming 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. 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. 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. Leads and/or assists the team to develop 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. Assists the team to review ISS and ISE reports towards regulatory submission. Work closely with medical affairs, market access, pharmacovigilance, programming, and other biostatistician Develop statistical analysis plans (SAPs) to meet publication or HTA submission standards, coordinate and perform data analysis and validation as necessary, and provide data interpretation. 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. 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. Other duties as assigned. Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities Make Intercept a truly desired place to work

QUALIFICATIONS

PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 3 years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 5 years of biostatistical experience in the clinical trials or health research environment. Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics Familiarity with pharmacokinetic/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. e

CTD BLA/NDA

experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of

MAA 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. Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines. Requires understanding of the company's products, the competition, and the pharmaceutical industry in general Maintains current awareness of new drug developments in the business. Learning agility and 'scalability' to take on increasing responsibility as Intercept grows Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity Ability to have fun and thrive in a growing, diverse and inclusive work environment. Thanks and Regards Divya Kumari