Location: Cary, NC, Remote
Organization: ACI Clinical
Job Type: Full Time - Regular
Description and Requirements
ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.
WHY WE LOVE WCG: At WCG, our employees are our most valuable asset and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health and to help them make the most of their future.
- Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
- Employee Assistance Programs and additional work/life resources
- Referral Bonuses and Tuition Reimbursement
- Flexible PTO
- Volunteer Time Off to benefit the community
- Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement
The expected base salary range for this position is $131,000 to $160,000. This salary range may vary based on the candidate's qualifications, experience, skills, education, and geographic location.
JOB SUMMARY: The Principal Biostatistician serves as the senior statistical expert and primary liaison for WCG clients, independently providing advanced statistical analysis and programming support across multiple clinical research projects. This role drives high-quality deliverables by leading complex analyses, preparing statistical reports, mentoring staff, and ensuring alignment with evolving regulatory standards and industry best practices.
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The accountabilities listed below are representative of the knowledge, skills, and/or ability required.
- Present interim clinical trial data and results to DMCs.
- Function as the primary statistical contact for assigned projects, ensuring client needs are met.
- Lead advanced statistical analyses, including efficacy and futility interim analyses for DMCs.
- Program and validate complex analysis datasets in support of clinical trial objectives.
- Prepare and review statistical reports, memos, and documentation.
- Provide statistical input for statements of work, proposals, and budgets.
- Mentor and guide junior biostatisticians and programmers.
- Oversee and provide expert input on protocol, statistical analysis plan, and trial design development.
- Author and review statistical sections for regulatory submissions and publications.
- Collaborate cross-functionally with internal teams (clinical, regulatory, data management) and external clients.
- Lead or contribute to process improvement initiatives within the Biostatistics team.
- Provide statistical training to colleagues or clients as needed.
- Manage workload across multiple projects and clients, effectively prioritizing responsibilities.
- Support regulatory strategy and assist with responding to agency questions or inquiries.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
EDUCATION REQUIREMENTS: MS or equivalent degree in statistics/biostatistics required, PhD strongly preferred.
QUALIFICATIONS/EXPERIENCE:
- Minimum six years of post-Master’s experience in clinical trials required.
- Demonstrated proficiency in statistical programming (SAS required; R strongly preferred).
- Proven analytical, communication, and presentation skills.
- Experience leading major statistical analyses and collaborating directly with clients.
- Extensive knowledge of clinical trial methodologies and regulatory standards.
TRAVEL REQUIREMENTS:
| ☒ 0% – 5% | ☐ 5% - 10% | ☐ 10% - 20% | ☐ 20% - 50% | ☐ >50% |
Physical and Sensory Requirements: The physical and sensory requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding). Majority of time is spent in a seated position with frequent opportunity to move about at will. Activities require a variety of easy muscle movements. Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively. There will be a need to attend to single or simultaneous tasks where accuracy of details is important. The need for detailed and precise work is high.