Sr. Biostatistician

About the role

Serves as the statistical lead for multiple clinical studies, representing Biometrics on one or more study management teams. Provides statistical direction and support for study design, analysis, and reporting, in order to expedite the conduct and evaluation of clinical trials and basic research. Performs statistical analysis of clinical trial data.

Responsibilities

• Represents Biometrics on one or more study management teams, as appropriate for the clinical program
• Collaborates with Clinical Development and Medical Writing project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports
• In collaboration with the program lead statistician, identifies appropriate, efficient experimental designs and defines analysis endpoints. Develops randomization plans and determines appropriate statistical methods of analysis for clinical studies
• Reviews clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements
• Prepares statistical analysis plans for approval
• Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings
• Maintains monitoring and reporting on CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to
• Provides biostatistical support to nonclinical, medical affairs, and commercial areas of the company
• Affords assistance in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical software
• Performs independent research as needed and explores, develops, and implements new statistical methods for the analysis of clinical study data
• Performs other duties as assigned

Requirements

• Master’s degree in statistics or biostatistics, or a related discipline AND 4+ years of relevant experience OR PhD in statistics or biostatistics, or a related discipline preferred AND 2+ years of relevant experience
• Understands key business drivers and uses this understanding to accomplish work
• Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
• Proficient with tools and processes that support work conducted by functional area
• Able to work as part of a team; may train lower levels
• Excellent computer skills
• Strong communications, problem-solving, analytical thinking skills
• Detail oriented yet can see broader picture for department
• Able to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills
• Solid expertise in the design, analysis, and reporting of clinical studies
• Strong organizational skills and proven ability to effectively lead the statistical aspects of multiple clinical studies simultaneously
• Strong knowledge of the SAS programming language with a specific emphasis in SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
• Good knowledge of CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
• Broad knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Experience in interacting directly with regulatory authorities highly desirable
• Maintains expertise in modern data manipulation and statistical analysis methodologies

Qualifications

Master’s degree in statistics or biostatistics, or a related discipline AND 4+ years of relevant experience OR PhD in statistics or biostatistics, or a related discipline preferred AND 2+ years of relevant experience

Skills

• Statistical analysis
• Statistical programming
• CDISC standards
• Regulatory guidelines
• Statistical software proficiency (SAS)
• Project management
• Biostatistical support
• Independent research
• New statistical method development

Benefits

• Annual base salary range: $110,800.00-$151,000.00
• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in equity-based long-term incentive program
• Retirement savings plan (with company match)
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage