AD/Director, Biostatistics

Job Title: Director, Biostatistics

Reports To: Chief Medical Officer    

Position:

The Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. Successful candidate will also interact with internal and external cross-functional study teams, supporting interactions with Health Authorities globally, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.

Role Responsibilities:

• Leads statistical and statistical programming team at the product level
• Provides statistical input to strategic planning, study design, protocol development, sample size calculation, Case Report Form, Results Interpretation, clinical study report, and addressing questions from regulatory agencies. Develop and maintain SAPs, including the derived variables, the templates of statistical tables, figures, and listings
• Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high-quality data
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
• Works collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
• CRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide CRO biostatisticians and statistical programmers. Ensures deliverables are accurate and delivered according to the timelines
• Global Health Authority Interaction: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities
• Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities; attend team meetings

Required Qualifications:

• PhD in statistics or biostatistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 10+ years relevant experience in the pharmaceutical/biotechnology industry
• NDA submission experiences
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.
• Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions
• Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process
• Excellent programming skills in SAS and/or R
• Excellent oral and written communication skills
• Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors

Mediar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other classification protected under applicable law.  Mediar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. 

Job Title: Associate Director, Biostatistics

Reports To: Chief Medical Officer   

Position:

The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.

Role Responsibilities:

• Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
• Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
• Translates scientific questions into statistical terms and statistical concepts into layman terms
• Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
• Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
• Communicates effectively with clinical and regulatory partners and external opinion leaders
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
• Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
• Compliant with company processes and SOPs, global and project standards, and responsible for quality of deliverables
• Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
• Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
• Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
• Drives alignment at team level
• Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
• Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
• Keeps up-to-date with state-of-the art applied statistical methodology

Required Qualifications:

• Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master’s degree with relevant experience required.
• Understanding of the application of biostatistics to medical/clinical trials data.
• Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals
• Excellent verbal and written communications skills.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities.
• Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

Mediar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other classification protected under applicable law.  Mediar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.