Statistical Science Director
Green Key Resources · Durham, North Carolina, United States
FULL TIMEpermanent
Job Description
Job DescriptionStatistical Science Director – Infectious Disease
If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.
Location: Durham, NC or Gaithersburg, MD (Hybrid, 3 days onsite)
Position Overview
We are seeking an experienced Statistical Science Director to lead biostatistical strategy across clinical development programs, with a focus on infectious diseases. This is a highly visible leadership opportunity responsible for clinical trial design, statistical analysis, regulatory strategy, and cross-functional collaboration.
The ideal candidate will have strong pharmaceutical industry experience, demonstrated leadership across multiple clinical studies, and the ability to independently guide statistical decisions. Experience in vaccines or immunotherapy is preferred but candidates from other therapeutic areas will be considered.
Key Responsibilities
Lead statistical strategy, clinical trial design, and analysis across drug development programs.
Provide statistical leadership for regulatory submissions, development plans, and health authority interactions.
Oversee statistical deliverables across multiple studies, ensuring quality and regulatory compliance.
Partner with clinical development, regulatory affairs, and other cross-functional teams.
Apply advanced statistical methodologies, including simulation-based approaches and innovative trial designs.
Guide internal statisticians and external CRO partners to ensure timely, high-quality deliverables.
Present statistical recommendations to senior leadership and governance committees.
Mentor and provide technical guidance to statistical team members.
Required Qualifications
Master's degree or PhD in Statistics, Biostatistics, Mathematics, or a closely related field.
Minimum 5 years of clinical trial experience within the pharmaceutical or biotechnology industry.
Demonstrated experience independently leading statistical strategy for clinical development programs.
Strong understanding of clinical trial design, statistical methodology, and regulatory requirements.
Experience overseeing statistical activities across multiple clinical studies.
Strong communication, stakeholder management, and cross-functional leadership skills.
Preferred Qualifications
Experience in infectious diseases, vaccines, or immunotherapy, although other therapeutic areas are welcome.
Experience supporting regulatory submissions and health authority interactions.
Expertise in simulation methods, sample size determination, or interim analyses.
Programming experience with SAS, R, or Python.
Experience mentoring statisticians or leading statistical teams.
Publications, external scientific collaborations, or recognition as a statistical methodology expert.
Additional Details
Hybrid schedule with a minimum of 3 days per week onsite.
Location flexibility between Durham, NC and Gaithersburg, MD.
Competitive base salary with flexibility for highly qualified candidates. xzbcwsv
Opportunity to influence clinical development strategy and contribute to innovative therapies.
If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.
Location: Durham, NC or Gaithersburg, MD (Hybrid, 3 days onsite)
Position Overview
We are seeking an experienced Statistical Science Director to lead biostatistical strategy across clinical development programs, with a focus on infectious diseases. This is a highly visible leadership opportunity responsible for clinical trial design, statistical analysis, regulatory strategy, and cross-functional collaboration.
The ideal candidate will have strong pharmaceutical industry experience, demonstrated leadership across multiple clinical studies, and the ability to independently guide statistical decisions. Experience in vaccines or immunotherapy is preferred but candidates from other therapeutic areas will be considered.
Key Responsibilities
Lead statistical strategy, clinical trial design, and analysis across drug development programs.
Provide statistical leadership for regulatory submissions, development plans, and health authority interactions.
Oversee statistical deliverables across multiple studies, ensuring quality and regulatory compliance.
Partner with clinical development, regulatory affairs, and other cross-functional teams.
Apply advanced statistical methodologies, including simulation-based approaches and innovative trial designs.
Guide internal statisticians and external CRO partners to ensure timely, high-quality deliverables.
Present statistical recommendations to senior leadership and governance committees.
Mentor and provide technical guidance to statistical team members.
Required Qualifications
Master's degree or PhD in Statistics, Biostatistics, Mathematics, or a closely related field.
Minimum 5 years of clinical trial experience within the pharmaceutical or biotechnology industry.
Demonstrated experience independently leading statistical strategy for clinical development programs.
Strong understanding of clinical trial design, statistical methodology, and regulatory requirements.
Experience overseeing statistical activities across multiple clinical studies.
Strong communication, stakeholder management, and cross-functional leadership skills.
Preferred Qualifications
Experience in infectious diseases, vaccines, or immunotherapy, although other therapeutic areas are welcome.
Experience supporting regulatory submissions and health authority interactions.
Expertise in simulation methods, sample size determination, or interim analyses.
Programming experience with SAS, R, or Python.
Experience mentoring statisticians or leading statistical teams.
Publications, external scientific collaborations, or recognition as a statistical methodology expert.
Additional Details
Hybrid schedule with a minimum of 3 days per week onsite.
Location flexibility between Durham, NC and Gaithersburg, MD.
Competitive base salary with flexibility for highly qualified candidates. xzbcwsv
Opportunity to influence clinical development strategy and contribute to innovative therapies.
Details
| Company | Green Key Resources |
| Location | Durham, North Carolina, United States |
| Type | FULL TIME |
| Niche | general |
| Experience | permanent |