Principal Biostatistician - Remote

MMS

Indianapolis (IN)

Remote

USD 90,000 - 120,000

Full time

14 days+

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Job summary

A clinical research organization is seeking a Principal Biostatistician for a remote role. The ideal candidate will have over 7 years of experience in biostatistics, possess a Master's or PhD, and demonstrate high-level expertise in statistical analysis and project management. Responsibilities include developing statistical analysis plans, collaborating with teams, and providing insights into drug development processes, all within a supportive and innovative environment.

Qualifications

Minimum of 7 years’ experience in Biostatistics, Statistics, or similar field.
Hands‑on experience preferred in clinical trial and pharmaceutical development.
Familiarity with ISO 9001 and ISO 27001 standards preferred.

Responsibilities

Create randomization and kit schedules independently.
Develop SAPs and iSAPs text and shells with no supervision.
Review or create statistical sections of a Sponsor’s protocol.

Skills

Biostatistics expertise

Statistical analysis

Project management

Communication skills

Problem-solving skills

Education

Masters in Biostatistics or related field

PhD preferred

Tools

MS Office

Job description

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Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Roles and Responsibilities

Can create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams
Can develop SAPs and iSAPs text and shells with no supervision
Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments
High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques
Has the ability to apply drug development knowledge during production of complex statistical analyses
Can perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations
Leads complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor
Is familiar with and stays current with the latest industry practices and updated regulatory guidelines
Understands the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)
Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician
Has high level knowledge of drug development as it pertains to biostatistics
Produces and presents external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction
Write blogs and/or white papers for posting on the company website
Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study
High proficiency with MS Office applications
Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management
Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers

Requirements

Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred
Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required
Submission experience (ISS/ISE)
Expert knowledge of scientific principles and concepts.
Reputation as emerging leader in field with sustained performance and accomplishment
Proficiency with MS Office applications.
Hands‑on experience with clinical trial and pharmaceutical development preferred
Good communication skills and willingness to work with others to clearly understand needs and solve problems.
Excellent problem‑solving skills.
Good organizational and communication skills.
Familiarity with current ISO 9001 and ISO 27001 standards preferred.
Familiarity with 21 CFR Part 11, FDA, and GCP requirements
Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process