About the Role
ClinChoice is seeking a highly skilled and strategic Senior Manager Biostatistician Consultant to join our premier consulting division. This unique role offers the best of both worlds: the opportunity to work directly and intimately for a single sponsor while enjoying the long-term security, global infrastructure, and diverse career advancement opportunities provided by a leading global Contract Research Organization (CRO). As a client-facing lead, you will be a critical partner in the clinical development process, requiring a blend of technical mastery, independent drive, and the ability to foster high-trust relationships with external stakeholders. This is a fully remote position designed for a professional who thrives in a collaborative, quality-focused environment and is passionate about delivering life-changing therapies to patients.
Key Responsibilities- Act as the primary statistical representative for assigned clinical trials, working closely with cross-functional study teams and sponsor-side project statisticians.
- Drive the design and development of early and late-stage clinical protocols across multiple therapeutic areas, ensuring scientific rigor and alignment with regulatory expectations.
- Lead the authoring and refinement of Statistical Analysis Plans (SAPs), including the creation of comprehensive Table, Listing, and Figure (TLF) shells.
- Execute and oversee complex statistical analyses for interim and final Clinical Study Reports (CSRs) to be submitted to global regulatory agencies such as the FDA and EMA.
- Provide strategic oversight and hands-on support for submission-level activities, including the design, analysis, and reporting of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE).
- Ensure all deliverables adhere to CDISC standards, including SDTM and ADaM specifications, and maintain strict compliance with ICH-GCP guidelines.
- Interpret complex data findings and present statistical results to non-statistical stakeholders, providing clarity on study outcomes and potential impacts on development programs.
- Proactively identify project risks and implement mitigation strategies to ensure data integrity and the timely delivery of high-quality statistical outputs.
- A Ph.D. or Master’s degree in Biostatistics, Statistics, or a related quantitative field with a strong emphasis on clinical trial methodology.
- A minimum of 8 years of experience within a pharmaceutical, biotechnology, or CRO environment, specifically in a biostatistical role.
- Proven experience in leading statistical activities for successful regulatory submissions (NDA, BLA, or MAA) and interacting with regulatory authorities.
- Expert-level proficiency in SAS programming; experience with R or other advanced statistical software is highly desirable.
- In-depth knowledge of CDISC standards, including the practical application of SDTM and ADaM models.
- Demonstrated ability to work independently in a remote setting while managing multiple high-priority projects simultaneously.
- Exceptional interpersonal and communication skills, with a track record of building successful partnerships with client counterparts and internal teams.
- Strong analytical thinking and problem-solving capabilities with a meticulous attention to detail.
- Competitive salary and a performance-based bonus structure designed to reward excellence.
- Flexible remote work arrangements to support a healthy and productive work-life balance.
- Comprehensive health, dental, and vision insurance plans for you and your dependents.
- Robust 401(k) retirement savings plan with company matching contributions.
- Generous Paid Time Off (PTO) and paid company holidays to ensure rest and rejuvenation.
- Continuous professional development through internal training programs, certifications, and industry conferences.
- A supportive and inclusive culture that prioritizes professional growth and mentorship within a global network of experts.