Remote opportunity at
MMSBiostatistician - Home Based (SA)
MMS seeks a Biostatistician - Home Based (SA) to join its data-focused clinical research organization. MMS is an award-winning, Great Place to Work certified company providing…
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About This Role
MMS seeks a Biostatistician - Home Based (SA) to join its data-focused clinical research organization. MMS is an award-winning, Great Place to Work certified company providing scientific support to the pharmaceutical, biotech, and medical device industries across four continents. This home-based role is suited for an experienced professional with a background in biostatistics, mathematics, or statistics who wants to contribute to clinical trial data management and regulatory submissions. In this…
Job Description
MMS seeks a Biostatistician - Home Based (SA) to join its data-focused clinical research organization. MMS is an award-winning, Great Place to Work certified company providing scientific support to the pharmaceutical, biotech, and medical device industries across four continents. This home-based role is suited for an experienced professional with a background in biostatistics, mathematics, or statistics who wants to contribute to clinical trial data management and regulatory submissions.
In this position, the biostatistician will independently build randomization and kit schedules, handle statistical analysis plans across phases 1 through 4, calculate sample sizes, and manage client meetings. The role requires strong programming skills in SAS, familiarity with CDISC standards like SDTM and ADaM, and the ability to lead projects and submissions while collaborating closely with programmers, regulatory teams, and sponsors.
Responsibilities
- Create randomization and kit schedules independently and collaborate with sponsor, randomization, and drug supply management teams
- Develop phase 1 through 4 statistical analysis plans and contribute significantly to iSAPs
- Build statistical analysis plan table, listing, and figure shells for all phases and studies
- Review analysis data model datasets and tables, listings, and figures, working with clients and programmers to resolve comments
- Perform sample size calculations for various study designs and scenarios
- Lead projects, smaller submissions, and client meetings while collaborating with regulatory, project management, and sponsor teams
- Provide unblinded statistician support to Data Safety Monitoring Boards by preparing and presenting output
- Review and create the statistical sections of sponsor protocols with minimal support
- Estimate project management-related tasks including timelines, scope, and resource requirements
- Prepare and review statistical methods and results sections for clinical study reports alongside medical writers
Requirements
- Minimum of 5 years of experience in biostatistics or a similar field
- Strong programming, SAS base, and SAS macro experience
- Strong experience with data and production of tables, listings, and graphs
- Expert knowledge of scientific principles and concepts with high-level knowledge of drug development as it pertains to biostatistics
- Strong knowledge of CDISC standards, particularly SDTM and ADaM
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements
- Proficiency with Microsoft Office applications
- Good communication, organizational, and problem-solving skills
Qualifications
- College graduate in Biostatistics, Statistics, Mathematics, or a related discipline
- Master's or PhD degree preferred
- Thorough knowledge and understanding of clinical data
- Hands-on experience with clinical trial and pharmaceutical development
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the remote policy for this Biostatistician role?
The posting specifies that the role is home-based.
What level of experience is required for this position?
Candidates must have a minimum of 5 years of experience in biostatistics or a similar field, along with a degree in biostatistics, statistics, mathematics, or a related discipline.
What technical skills are needed to apply?
Applicants need strong SAS programming, SAS base, and SAS macro experience, proficiency with Microsoft Office applications, and familiarity with CDISC standards such as SDTM and ADaM.
How long will it take to hear back after submitting an application?
The posting notes that if you are not contacted within 14 days of your submission, you should consider your application unsuccessful.
What salary and benefits are offered?
The job posting does not specify salary or benefits information.
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