Director, Biostatistics - REMOTE

Proclinical is seeking a remote Director, Biostatistics for a leading biotech company.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• Leads collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
• Leads/conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
• Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
• Authors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listings
• Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
• Designs and specifies randomization schedules; reviews and approves test randomization lists
• Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
• Reviews analysis dataset specifications
• Performs QC/QA of statistical deliverables including validation of key analysis results
• Performs ad hoc and exploratory statistical analyses as needed
• Contributes to clinical study reports, including authoring of statistical methods and interpretation of the study results
• Be accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
• Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
• Supports and contributes to the preparation of publications, including manuscripts, posters and oral presentations
• Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts
• Represents company regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
• Serves as a mentor to junior team members

Skills and Requirements:

• Ph.D. (Strongly preferred) or Master's degree in statistics or related discipline
• Eight years (Ph.D.) or ten years (Master) or more experience in the pharmaceutical or biotech industry
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials
• Experience in NDAs, MAAs or other regulatory submissions desirable
• In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
• In-depth knowledge of FDA, EMA and ICH regulations and guidelines
• Proficient in statistical programming in SAS and R
• Proficient in statistical design software such as EAST
• Ability to concurrently lead statistical efforts for multiple studies
• Understanding of data standards, including SDTM and ADaM
• Ability to oversee statistical services provided by CRO's and/or contractors
• Ability to work independently, guide team and junior biostatisticians, and act with initiative to address issues
• Ability to collaborate effectively with colleagues from all other functions
• Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner.

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at (+1) or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.