Principal Biostatistician - Rockville, MD | Biospace
Get Our FREE Industry eNewsletter

Principal Biostatistician

MacroGenics, Inc.

Rockville, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Biotechnology, Clinical Trial, Oncology, Pharmaceutical, PhD, SAS,

Job Description

Summary of Position

The Principal Biostatistician is responsible for providing expert technical guidance and serving as a statistical consultant for other biostatisticians, providing strategic statistical input on the target patient value profile, clinical development and regulatory submission plans for the cross-functional team.  He/she oversees the entire design, development and evaluation process of the technical/statistical infrastructure for the conduct and evaluation of all clinical trials or for the analysis of complex research studies for which novel approaches are required, from inception to completion, and is recognized as one of the organization’s technical professionals.  The individual is responsible for ensuring common line-of-sight between the biostatistician study lead, other biostatisticians and statistical programmers, as well as external partners, of all deliverables and timeline expectations across the therapeutic area, key indication or compound under their scope of influence.

Responsibilities and Job Duties:
* Functions as lead biostatistician on multiple clinical studies, provides statistical scientific leadership to projects and contributes to clinical development plan and strategy
* Leads and manages the technical operations of assigned projects and provides technical guidance and mentoring to the project team
* Collaborates with Data Management on the development and review of CRFs, data cleaning, and database design and with Statistical Programming on the development of data outputs and reporting database, as well as providing guidance on statistical programming
* Writes and reviews statistical sections of protocols, statistical analysis plans, statistical programming plans, clinical study reports, and other study related documents
* Serves as statistical expert in the therapeutic area, key indication or compound under their purview and provides strategic input to the target patient value profile, clinical development plan, regulatory submission plan and the life cycle of a development compound, by suggesting innovative statistical methods that will help accelerate the development process or market access
* Coordinates the work of the biostatistician study lead, other biostatisticians and statistical programmers assigned to the Mission for the therapeutic area and/or indication to ensure high quality of statistical deliverables in close collaboration with external vendor partners. Acts as a technical resource for less experienced biostatisticians
* Makes technical presentations, both internally and externally, and is recognized as an authority on a wide range of topics relevant to their area of technical expertise
* In the role as project leader, conducts briefings and participates in technical meetings for internal and external representatives (e.g. FDA, EMEA, etc.)
* Contributes to the preparation of regulatory interaction (meeting requests, briefing documents, etc.) and regulatory submission (ISS, ISE, etc.), as needed
* Ensures compliance with and participates in development of MacroGenics’ SOPs and ICH GCP regulations and ensures that the biostatistics aspects of trial design, conduct, analysis, data reporting and data interpretation are conducted in an accurate, efficient, ethical and complete manner
* Manages and coordinates the biostatistical deliverables required for the NDA/MAA submission for the clinical program and ensures the deliverables are completed accurately and in accordance with timelines. If this is delegated to an external partner biostatistician, reviews the biostatistical deliverables by the assigned vendor.
* Provides input for pooling strategies for submissions and IND updates, and provides statistical input into the Investigator Brochure
* Reviews sections of NDA/MAA submissions (including ISE, ISS, summary of clinical efficacy, summary of clinical safety, clinical overview, and any other specific sections of importance [e.g., cardiac safety report, abuse liability report, suicidality report, and risk management plan]) and attends and contributes to all related roundtable discussions
* Develops, maintains and ensures standardization across the clinical studies within the clinical program. Adheres to the GSS global standards


Ph.D. or M.S. in Biostatistics or strongly related field

* Four years of experience with a Ph.D.; or 6 years of experience with a M.S. Experience must be in pharmaceutical, biotechnology, CRO industry or a related clinical trials environment
* Demonstrated experience in the application of statistical methodology in the planning, design, analysis and interpretation of clinical trial data with particular experience in the design and analysis of oncology studies
* Demonstrated experience in using SAS and other relevant software for trial design, simulation and analysis
* Experience in providing statistical support for the life cycle of a development compound (from phase I/II through phase IV and post approval activities)

Knowledge, Skills and Abilities
* Demonstrated understanding of regulatory guidance on clinical trials, endpoints and issues, particularly in oncology area
* Demonstrated capability to effectively manage multiple tasks and projects with excellent attention to detail
* Highly advanced expertise in developing and incorporating novel methodologies into current processes and protocols
* Must have excellent written and verbal communication skills in English
* Excellent technical writing and presentation skills
* Proven ability of excellent cross-functional project management skills, including an impressive track record of consistently meeting all project timelines and objectives
* Understands the implications of the pharmacokinetic profile of a drug on the design of pharmacodynamics and Phase I-III studies, or vice versa
* Familiarity with later Phase studies, i.e. non-interventional, retrospective studies, or experience working with Health Technology Assessment (HTA) bodies
* Able to coordinate a team of biostatisticians and statistical programmers in the execution of a clinical program to support therapy area biostatistical deliverables
* Sound knowledge of the ICH guidelines. * Understanding of the regulatory requirements from EU, US and Japanese health authorities, and of the submission process in each
* Experience with NDA/MAA submissions
* Knowledge of advanced statistical methodology
* Project management skills
* Knowledge in SAS and/or R programming
* Able to work under pressure and without close supervision
* Able to explain advanced statistics in a non-technical manner to non-statisticians
* Able to multi-task and anticipate future statistical needs and the maturity to work in a highly independent, self-motivated manner
* Able to pro-actively propose and defend alternative and often innovative study designs and statistical methods
* Provides examples of being a self-starter who is self-directed and self-motivated without putting self-first

Supervisory Responsibilities: