Biostatistician

Description:

This contract Biostatistician will lead support for one or multiple therapeutic areas to ensure that Company Research and Development projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. Accountable directly or through subordinates for the statistical strategy and design in all projects in their therapeutic area(s) for full compound development and product life cycle. Provides input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy. Represent Biostatistics in meetings with cross-functional project teams and regulatory agencies. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training leading in the development and adaptation of new statistical methodology in support of drug research and development as required keeping current with regulatory guidance and requirements in the global environment hiring, mentoring and managing employees to maintain a competent and qualified staff selecting and hiring qualified and cost-effective CRO's to supplement internal resources and monitoring the performance of CRO's to ensure high quality products and services.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

• Plans, organizes, and directs the activities of Biostatistics to support one or more therapeutic areas to ensure that Intercept's clinical programs are optimally designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products.

• Participates in establishing and maintaining policies, standards, and procedures for global Biostatistics.

• Leads in development and adaptation of new statistical methodology in support of research and development, keeping current with regulatory guidance and requirements in the global environment.

• Provides statistical consultations and strategic inputs in terms of drug development for cross-functional teams within the company.

• 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.

• Hires, mentors and manages employees to maintain a competent and qualified staff.

• Selects and hires qualified and cost-effective CRO's to supplement internal resources and monitors the performance of CRO's to ensure high quality products and services. 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.

• Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships demonstrated ability to proactively maximize relationships to enable successful collaboration.

• Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals.

• 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.

• 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.

• 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.

• Train and mentor new statisticians.

• 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

Skills:

Biostatistics, Sas programming, Clinical research, CDISC, SDTM, ADaM, Sas, Statistical analysis, TLF, Clinical trial

Additional Skills & Qualifications:

• PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 6 years of relevant work experience OR a Master degree in Statistics, Biostatistics or a related health science field, and 8 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.

• 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.

You can send your resume directly to Gavin at gpacheco@actalentservices.com

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.