Associate DirectorDirector of Biostatistics

Gaithersburg, MD - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

Contract-to-Hire
On-Site/hybrid - Candidates must be local to Gaithersburg MD

Job Summary:
Reporting to the Vice President of Biostatistics and Data Management this individual will provide statistical leadership and serve as a study statistician within development. S/he will work collaboratively with clinical and development teams including clinicians clinical scientists statistical programmers data managers regulatory and clinical operations professionals to plan conduct and analyze clinical studies of all phases. Responsible for the overall quality of statistical design programming analysis and data reporting. Represents the company in interactions with outside statistical and data management service providers and participates in discussions with regulatory agencies.

Essential Functions:

Provides statistical expertise and leadership to ensure program objectives are in alignment with regulatory and clinical study designs
Working closely with statistical programmers to provide outputs and analyses to support NDA/BLA submission to regulatory authorities
Contribute to strategic planning and go/no go decision guidance
Directs development of statistical analysis plans and reviews statistical programming
Ensures timely and accurate delivery of clinical study data analysis results
Interprets clinical trial data and contributes to the preparation of clinical manuscripts and regulatory submission documents
Lead statistical strategy for clinical development programs including MASH and obesity indications.
Develop and review statistical sections of protocols SAPs CRFs and clinical study reports.
Collaborate with cross-functional teams (Clinical Regulatory Data Management Medical Affairs) to ensure alignment on study design and analysis.
Oversee statistical deliverables from CROs and ensure quality and compliance with ICH-GCP and regulatory standards.
Perform or supervise statistical analyses for interim and final study results.
Contribute to regulatory submissions (INDs NDAs BLAs) and responses to health authorities.
Support external publications and presentations of clinical data.
Mentor statistical programmer in AI/ML area and contribute to departmental growth and innovation.
Evaluate and implement innovative statistical techniques that will provide benefit to clinical development programs

Job Requirements (Essential knowledge skills and attributes):

PhD or Masters in Statistics Biostatistics or related field. MS with significant industry experience
At least 5 years of prior experience working for biotech pharma or CRO
5 years (Associate Director) / 8 years (Director) of experience in clinical trial statistics within biotech/pharma.
Strong knowledge of statistical methods for clinical trials including longitudinal data survival analysis and Bayesian approaches.
Experience with regulatory interactions and submissions.
Experience with metabolic diseases is highly desirable
Proficiency in SAS and/or R; experience with CDISC standards (SDTM ADaM).
Excellent communication and leadership skills
A self-directed individual who can excel both independently and as a team player in a fast-paced entrepreneurial environment
History of successful participation within an interdisciplinary team.

Preferred Experience

Prior work in liver disease or metabolic indications (e.g. NASH/MASH obesity)
Experience with external control arms or synthetic cohort matching
Familiarity with non-invasive biomarkers and imaging endpoints
Working experience or knowledge with AI/ML.

Required Experience:

Director

Job DescriptionContact: Neisha Camacho/Terra Parsons - No 3rd party candidatesContract-to-HireOn-Site/hybrid - Candidates must be local to Gaithersburg MDJob Summary:Reporting to the Vice President of Biostatistics and Data Management this individual will provide statistical leadership and serve as ...

Job Description

Essential Functions:

Provides statistical expertise and leadership to ensure program objectives are in alignment with regulatory and clinical study designs
Working closely with statistical programmers to provide outputs and analyses to support NDA/BLA submission to regulatory authorities
Contribute to strategic planning and go/no go decision guidance
Directs development of statistical analysis plans and reviews statistical programming
Ensures timely and accurate delivery of clinical study data analysis results
Interprets clinical trial data and contributes to the preparation of clinical manuscripts and regulatory submission documents
Lead statistical strategy for clinical development programs including MASH and obesity indications.
Develop and review statistical sections of protocols SAPs CRFs and clinical study reports.
Collaborate with cross-functional teams (Clinical Regulatory Data Management Medical Affairs) to ensure alignment on study design and analysis.
Oversee statistical deliverables from CROs and ensure quality and compliance with ICH-GCP and regulatory standards.
Perform or supervise statistical analyses for interim and final study results.
Contribute to regulatory submissions (INDs NDAs BLAs) and responses to health authorities.
Support external publications and presentations of clinical data.
Mentor statistical programmer in AI/ML area and contribute to departmental growth and innovation.
Evaluate and implement innovative statistical techniques that will provide benefit to clinical development programs

Job Requirements (Essential knowledge skills and attributes):

PhD or Masters in Statistics Biostatistics or related field. MS with significant industry experience
At least 5 years of prior experience working for biotech pharma or CRO
5 years (Associate Director) / 8 years (Director) of experience in clinical trial statistics within biotech/pharma.
Strong knowledge of statistical methods for clinical trials including longitudinal data survival analysis and Bayesian approaches.
Experience with regulatory interactions and submissions.
Experience with metabolic diseases is highly desirable
Proficiency in SAS and/or R; experience with CDISC standards (SDTM ADaM).
Excellent communication and leadership skills
A self-directed individual who can excel both independently and as a team player in a fast-paced entrepreneurial environment
History of successful participation within an interdisciplinary team.

Preferred Experience