Jobs at ClinChoice

Provides statistical expertise for Phase III oncology clinical trials, including study design, survival and time-to-event analyses, statistical outputs, TFL and ADaM specifications, interim analyses, and IDMC/DMC support. Collaborates with statistical programming and cross-functional teams, reviews SAS outputs, resolves discrepancies, supports regulatory submissions, and manages deliverables across multiple concurrent studies independently.

Provides regulatory CMC expertise for pharmaceutical and self-care products across new product development, lifecycle management, post-approval changes, and global submissions. Responsibilities include developing CTD Modules 2.3 and 3, assessing CMC changes, guiding manufacturing and analytical requirements, supporting health authority interactions, managing regulatory risks, and collaborating with R&D, Quality, Manufacturing, Supply Chain, and Regulatory teams.

Leads North American regulatory affairs for pharmaceutical and biotech clients, developing global regulatory strategies, overseeing submissions, ensuring compliance, advising on FDA and health authority requirements, and managing regulatory projects. The role includes authoring and compiling IND, CTA, BLA, MAA, and NDA documents, monitoring regulatory changes, mentoring and hiring staff, supporting client presentations, and contributing to department growth and digital process solutions.

Leads clinical pharmacology and PK/PD study design, protocol development, modeling and simulation, data analysis, regulatory reporting, and client collaboration. Uses pharmacokinetic software to support clinical trials, publications, and regulatory submissions. Provides scientific leadership, mentors junior pharmacologists, manages multiple projects, and applies current clinical pharmacology practices across pharmaceutical and biotechnology programs.

Leads statistical programming activities for clinical trials, including programming and validating datasets, tables, figures, listings, and electronic submissions. Oversees CRO and vendor deliverables, supports CDISC-compliant submissions, contributes to clinical documentation and standards, performs exploratory analyses, and provides technical guidance to programmers. Collaborates with cross-functional teams to ensure high-quality, timely deliverables.

Leads and supports statistical programming for clinical studies within a CRO environment. Implements protocol and clinical development programming, prepares specifications and documentation, ensures quality and regulatory compliance, supports standards and automation, coordinates team activities, escalates risks, and collaborates with statisticians, programmers, data managers, and study leaders.

Leads statistical activities for oncology clinical trials, serving as lead statistician for study strategy and deliverables. Authors and reviews Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports. Interprets analysis outputs, ensures regulatory compliance, collaborates with clinical, programming, data management, and regulatory teams, and guides statistical programmers. Communicates statistical results and risks to technical and non-technical stakeholders.

Lead statistical strategy and deliverables for clinical trials (primarily immunology), author and review SAPs and ADS, interpret analysis outputs, ensure regulatory compliance, collaborate with clinical, programming, data management and regulatory teams, oversee/mentor statisticians and programmers.

Lead design and execution of statistical analysis plans for large RWE studies; mentor junior analysts; build automated RWD workflows and advanced analytics/ML solutions; create dashboards and visualizations; advise clients on results and guide cross-functional integration of multiple data sources while improving methodologies and standards.

Develop and validate SDTM and ADaM datasets using R per CDISC standards, support TLF generation in R/SAS, perform QC and reconciliation, collaborate with statisticians and data teams, contribute to automation, documentation, and version control.

The Business Development Director is responsible for driving growth by securing new clients and expanding services, managing the full sales lifecycle, and maintaining relationships with key stakeholders in the life-sciences industry.