What are the responsibilities and job description for the Biostatistics, Associate Director (Remote) position at WCG?
General Information
Location: Cary, NC, Remote
Organization: Statistics Collaborative
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 to help make the most of their future.
JOB SUMMARY: The Biostatistics, Associate Director will provide statistical oversight on multiple projects. This role may serve as the lead statistician for Data Monitoring Committee (DMC) projects. This position will collaborate with internal and external stakeholders, including Sponsor teams, internal teams and committee members to support the statistical aspects of DMC operations across multiple assigned projects. This individual will work effectively with the project team and provide leadership to team biostatisticians and programmers.
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
Qualifications/Experience
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.
WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment based on merit and without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender expression, gender identity, age, marital status, family or parental status, disability, genetic information, citizenship, veteran status, or any other legally recognized basis or status protected by federal, state, or local law. WCG complies with the Vietnam Era Veterans' Readjustment Act and Section 503 of the Rehabilitation Act. We promote a "One WCG" culture where all are welcome, respected, valued, and empowered to make a difference every day to advance clinical research.
Location: Cary, NC, Remote
Organization: Statistics Collaborative
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 to help 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
JOB SUMMARY: The Biostatistics, Associate Director will provide statistical oversight on multiple projects. This role may serve as the lead statistician for Data Monitoring Committee (DMC) projects. This position will collaborate with internal and external stakeholders, including Sponsor teams, internal teams and committee members to support the statistical aspects of DMC operations across multiple assigned projects. This individual will work effectively with the project team and provide leadership to team biostatisticians and programmers.
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
- Assumes major responsibilities for clients and for the client’s projects.
- Assists Project Management with financial tracking of projects.
- Assumes leadership of statistical and programming work on projects.
- Serve as the primary statistical liaison for Data Monitoring Committees, as assigned, ensuring objective and independent statistical support.
- Lead the development and execution of analyses for DMC review, ensuring adherence to prespecified statistical analysis plans (SAPs) and charters.
- Provides statistical consulting services as needed in area of expertise.
- Provide independent and unblinded statistical support for DMC meetings, preparing interim reports, safety summaries, and efficacy analyses.
- A member of professional societies, attends meetings of these societies and may be an active member of professional societies. May serve as a peer reviewer of scientific manuscripts and proposals.
- May serve as a DMC/DSMB statistician.
- Maintain high standards of confidentiality and integrity when handling unblinded data.
- Remain abreast of current advances in biostatistics, clinical trial design, and applicable regulatory guidance.
- Guide and mentor junior biostatisticians, as needed, in DMC-related methodologies and best practices.
- Represent Biostatistics, as assigned, in cross-functional meetings, Sponsor meetings and DMC member meetings.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
- Ph.D. in Biostatistics, Statistics, or a related field with 5 years of experience OR Master’s degree with 8 years of experience in biostatistics within the pharmaceutical/biotech industry.
Qualifications/Experience
- At least eight years of post-Master’s industry experience in clinical trials
- Strong leadership, communication and presentation skills a must.
- Strong ability to effectively communicate complex statistical concepts to non-statisticians, including clinicians and regulatory reviewers.
- Organizational skills with the ability to manage multiple projects and priorities simultaneously.
- Demonstrated ability to work independently and collaboratively in a cross-functional environment.
- Strong expertise in interim analysis methodologies, adaptive designs, and statistical monitoring approaches, preferred.
- Proficiency in SAS, R, or other statistical programming tools for clinical trial analysis.
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.
WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment based on merit and without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender expression, gender identity, age, marital status, family or parental status, disability, genetic information, citizenship, veteran status, or any other legally recognized basis or status protected by federal, state, or local law. WCG complies with the Vietnam Era Veterans' Readjustment Act and Section 503 of the Rehabilitation Act. We promote a "One WCG" culture where all are welcome, respected, valued, and empowered to make a difference every day to advance clinical research.
Salary : $167,000 - $185,000
