About the Role: We are seeking a highly skilled and motivated Lead Biostatistician to join our dynamic team. The successful candidate will play a pivotal role in the design, analysis, and interpretation of clinical trials across Phases I–IV. As the lead biostatistical expert, you will contribute to the strategic planning of clinical studies and ensure the highest scientific rigor in biostatistical practices, collaborating with cross-functional teams to advance our research pipeline.
Key Responsibilities:
* Serve as the primary biostatistical lead for assigned clinical trials across Phases I–IV.
* Provide expert input into the design and development of clinical study protocols, including the formulation of statistical analysis plans (SAPs).
* Ensure methodological integrity by selecting appropriate statistical techniques tailored to each study's objectives.
* Collaborate closely with clinical, medical, data management, and regulatory teams to deliver high-quality, statistically sound analyses.
* Lead the preparation and review of statistical deliverables, including interim analyses, final study reports, and regulatory submission packages.
* Oversee and guide junior biostatisticians or statistical programmers, fostering a high-performance team environment.
* Stay abreast of regulatory guidelines and ensure adherence to relevant statistical and clinical standards (e.g., ICH, FDA, EMA).
* Engage in strategic planning, risk assessments, and innovative problem-solving to support study outcomes.
* Contribute to publications, presentations, and external engagements, showcasing biostatistical insights.
Qualifications:
* Advanced degree (Ph.D. or M.Sc.) in Biostatistics, Statistics, or a related field.
* Extensive experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.
* Must have study design and protocol contribution expertise
* Proficiency in statistical programming languages (e.g., SAS, R).
* Strong knowledge of clinical trial processes, including regulatory requirements and guidelines (e.g., ICH E9, GCP).
* Proven track record of leading biostatistical activities for clinical trials, including Phases I–IV.
* Exceptional communication and leadership skills, with the ability to convey complex statistical concepts to non-statistical stakeholders.
* Collaborative mindset and a passion for driving innovation in clinical trial design and analysis.