Director Biostatistics

About the role

Develops strategic and operating plans for area of responsibility. Serves as the overall statistical lead on multiple clinical programs and will provide statistical input in design, analysis, and reporting of clinical trials and basic research. Leads statistical analysis and maintains standards across studies within a clinical program. Interacts with key opinion leaders on protocol design. Oversees and directs the biostatistics team responsible for the analysis and reporting of data from clinical studies.

Responsibilities

• Manages in-house and contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programs
• Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies
• Represents Biometrics on one or more Dev Core Team or clinical sub team (as appropriate for the clinical program)
• Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports
• Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies
• Represents Biostatistics in interactions with regulatory agencies
• Prepares, reviews, and approves statistical analysis plans
• Oversees and monitors 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 as needed
• Leads the development of department standard operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical software
• Reviews, approves and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs
• Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for all projects in the program(s)
• Performs other duties as assigned

Requirements

• Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and reporting of clinical studies, including innovative and adaptive study designs and advanced statistical analysis methods. Extensive previous leadership experience required.
• OR PhD in statistics, biostatistics or related discipline AND 7+ years of similar experience noted above
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• See broader picture and evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Excellent leadership, coaching and development skills
• Strong negotiation and influencing skills
• Excellent communication, problem-solving, analytical thinking skills
• Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines
• Demonstrated experience in providing statistical leadership and strategic input regarding the overall drug development plan and commercialization activities
• Advanced knowledge of SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
• Solid knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
• Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Demonstrated experience in successfully interacting with regulatory authorities in meetings and written communications

Qualifications

• Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and reporting of clinical studies, including innovative and adaptive study designs and advanced statistical analysis methods. Extensive previous leadership experience required.
• OR PhD in statistics, biostatistics or related discipline AND 7+ years of similar experience noted above

Skills

• Extensive previous leadership experience
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• See broader picture and evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Excellent leadership, coaching and development skills
• Strong negotiation and influencing skills
• Excellent communication, problem-solving, analytical thinking skills
• Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines
• Demonstrated experience in providing statistical leadership and strategic input regarding the overall drug development plan and commercialization activities
• Advanced knowledge of SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
• Solid knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
• Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Demonstrated experience in successfully interacting with regulatory authorities in meetings and written communications

Benefits

• Annual base salary range: $199,300.00 - $272,000.00
• Annual bonus with a target of 35% of the earned base salary
• Eligibility to participate in our equity based long term incentive program
• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans