Forest Research Institute (FRI)
a wholly-owned subsidiary of Forest Laboratories, Inc.—drives the scientific research and development behind Forest’s top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institute’s highly skilled professionals enable Forest to license compounds at virtually any stage—from preclinical development to products that are ready for FDA review—and then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forest’s more than 5,000 employees—including our 1,000 person strong Research Institute—contributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
The role of the Associate Director is to perform statistical activities in clinical trials from protocol development to final study report for assigned Phase I-IV clinical projects. Function as the project statistician and provide statistical leadership for the Biostatistics, Statistical Programming, and Data Management study team. Provide statistical leadership for new drug in-licensing, development, submission, approval, and marketing.
Primary responsibilities include but not limited to:
Review protocol and prepare statistical sections, including sample size calculation.
Review CRF, database design, edit check specifications, and external data specifications.
Prepare detailed statistical analysis plan and table/figure/listing shells.
Work closely with Statistical Programmers in test runs, identify data quality issues for key efficacy and safety variables.
Work closely with Statistical Programmers in the final execution of statistical analyses.
Review final study report.
Provide statistical leadership for the Biostatistics, Statistical Programming, and Data Management study team.
Represent Biostatistics function on study team.
Provide statistical leadership in new drug in-licensing, development, submission, approval, and marketing.
Perform other ad-hoc statistical activities as needed for both internal and external requests.
Mentor Senior and Senior Principal Statisticians.
Participate in establishing standard operating procedures and working practices for Biostatistics department.
MS in Statistics or Biostatistics required, PhD is preferred.
At least 7 years of pharmaceutical statistics experience with specific experience in late stage drug development
Knowledge, Skills, and Abilities
Good knowledge of clinical trial methodologies, drug development, and FDA GCP/ICH regulatory guidelines
Good knowledge of SAS computer package
Knowledge of nQuery and splus is a plus
Knowledge of Unix is a plus
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook
Must possess excellent skill/ability in the following:
Oral and Written Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Team Building, Motivating Employees, Influencing Others
Forest Laboratories, Inc. - 18 months ago
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...