The primary responsibilities of this position are to provide statistical consulting to clients in the biotech/pharmaceutical industry in their drug development programs with a focus on protocol/study design, analysis planning, regulatory submission strategies, regulatory communication, mento ring of other statisticians in generating analyses for clinical studies and regulatory submissions and assist with business proposals. This position assumes a supervision responsibility on statistical personnel and job training.
Essential Job Functions:
- Provides statistical consulting to clinical study design.
- Reviews study protocols and writes statistical sections.
- Conducts sample size and power calculations.
- Proposes randomization methods and designs.
- Leads regulatory submission strategy planning for statistics function.
- Identifies issues, and provides solutions to clinical operation and data management for issues that potentially impact data analyses.
- Reviews and provides comments to statistical analysis plans that are written by the 3rd party.
- Develops statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions.
- Writes statistical reports for results interpretation, both for individual studies and integrated analyses for regulatory submissions, if needed.
- Prepares statistical sections of clinical study reports if needed.
- Reviews clinical study reports and other regulatory submission documents.
- Participates in clinical results interpretation meetings, both for individual studies and integrated analyses for regulatory submissions.
- Works with medical writers to assist with clinical study reports and ISS/ISE reports preparation.
- Participates in regulatory communication.
- Mentors junior statisticians in the ir support of client projects.
- Ensures that statistical personnel follow the standard operating procedures.
- Identifies department deficiencies/needs and proposes new and/or revision of standard operating procedures.
- Assists with preparation of business proposals.
- Conducts performance evaluation on staff.
Experience / Education:
- Master or Doctoral degree in Statistics or Biostatistics
- 8-14 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry, including minimum of 4 years of supervision experience
- Direct participation in design, planning, conduct, analyses, and reporting of clinical trials
- Direct participation in regulatory submission activities
Knowledge / Skills / Abilities:
- Deep understanding statistical concepts and methodology related to clinical trials and drug development
- Comprehensive knowledge on regulatory guidelines
- Excellent organizational and project management skills
- Excellent interpersonal and communication skills
Physical Requirements:
- Ability to stand or sit for most of the work day.
- Must be able to perform some activities with repetitive motion, such as keyboarding.
- If working remotely, must have access to high-speed internet service and have knowledge and ability to resolve IT and computer related challenges through remote communications channels.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.