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- Tasks: Lead complex biostatistical projects and collaborate with teams to drive clinical research success.
- Company: Join MMS, an award-winning CRO known for its innovative culture and exceptional employee satisfaction.
- Benefits: Enjoy remote work flexibility, a supportive team environment, and opportunities for professional growth.
- Why this job: Shape the future of clinical research while working in a collaborative and inclusive atmosphere.
- Qualifications: Masters in Biostatistics or related field with 7+ years of experience; PhD preferred.
- Other info: Be part of a Great Place to Work certified organisation with a global presence.
The predicted salary is between 54000 - 84000 £ per year.
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 aaward-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. Visitwww.mmsholdings.comor follow MMS onLinkedIn.
Principal Biostatistician:
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.
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Principal Biostatistician - Remote employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Biostatistician - Remote
✨Tip Number 1
Network with professionals in the biostatistics field, especially those who work in clinical research organisations. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and practices.
✨Tip Number 2
Familiarise yourself with the specific tools and software mentioned in the job description, such as statistical analysis software and project management tools. Being able to demonstrate your proficiency in these during interviews can set you apart from other candidates.
✨Tip Number 3
Stay updated on the latest regulatory guidelines and industry standards relevant to biostatistics. This knowledge will not only help you in interviews but also show your commitment to the field and your ability to adapt to changes.
✨Tip Number 4
Prepare to discuss your previous experiences leading complex projects and collaborating with cross-functional teams. Highlight specific examples where you successfully managed client meetings or provided statistical consulting support, as this aligns closely with the role's responsibilities.
We think you need these skills to ace Principal Biostatistician - Remote
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in biostatistics and clinical research. Emphasise your technical skills, particularly in statistical analysis and drug development, as these are crucial for the Principal Biostatistician role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for biostatistics and your understanding of the pharmaceutical industry. Mention specific projects or experiences that align with the responsibilities outlined in the job description.
Highlight Relevant Skills: In your application, clearly outline your proficiency with MS Office applications and any statistical software you have used. Discuss your experience with sample size calculations and statistical consulting, as these are key aspects of the role.
Showcase Leadership Experience: If you have led projects or teams in the past, make sure to include this in your application. Highlight your ability to manage client meetings and collaborate with various stakeholders, as this is essential for the position at MMS.
How to prepare for a job interview at MMS Holdings Inc
✨Showcase Your Expertise
As a Principal Biostatistician, it's crucial to demonstrate your high technical level and subject matter expertise. Be prepared to discuss specific biostatistical techniques you've used in past projects and how they contributed to successful outcomes.
✨Prepare for Technical Questions
Expect questions related to statistical methods, sample size calculations, and regulatory guidelines. Brush up on your knowledge of 21 CFR Part 11, FDA, and GCP requirements, as well as the latest industry practices to show you're up-to-date.
✨Highlight Collaboration Skills
MMS values a collaborative work environment. Be ready to share examples of how you've worked with cross-functional teams, managed client meetings, or provided statistical consulting support to sponsors. This will showcase your ability to thrive in a team setting.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss challenges you've faced in previous roles and how you approached solving them. Highlight your excellent problem-solving skills and your willingness to suggest solutions that align with organisational goals.
