Study Lead Statistician - Product Facing - The Steely Group

The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies. The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with regulatory requirements and company standards, and maintain statistical, as well as operational, integrity throughout the life of the study.

The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also works closely with the Study Statistician, who performs all the operational activities related to the statistics-related deliverables. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include regulatory activities as well as publication work.

Responsibilities:

• Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications.
• Attend and be a contributor at Clinical Study Team Meetings.
• Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review. Initiate cross-functional team meetings as necessary (e.g., SAP review, TFL shell review, TFL review).
• Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects.
• Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically).
• Perform data-driven modeling during clinical studies.
• Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM.
• Review TFLs created by statistical programming for consistency and accuracy.
• Author analysis reports such as Flash Memo, and results section of the CSRs.
• Collaborate with the study programming team for study deliverables.
• Manage timelines for all statistics-related deliverables by working with the cross-functional team members (e.g., programmers, study statisticians, clinical data managers, medical writers).
• Be familiar with all company policies, SOPs and other controlled documents related to study activities noted above.
• Assist with study and systems audits conducted by the company and external bodies.

Requirements / Qualifications:

• Master’s degree in Statistics/Biostatistics or other subject with high statistical content with at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research (or PhD degree with at least 3 years experience).
• Strong skill in communicating statistical information clearly and concisely (written and oral).
• Strong understanding of statistical concepts related to the design and conduct of clinical studies.
• Strong ability to apply statistical methodologies in the analysis of clinical trials.
• Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the pharmaceutical/biotechnology/public health setting in industry, government or academia.
• Previous experience in the development, author, and execution of protocols and SAPs, as well as review of CSRs.
• Excellent oral and written English communication skills.
• Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study designs.

Preferred Qualifications:

• Master’s degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research (or PhD degree with 5 years experience).
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) and at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings.
• Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight. Life cycle drug development experience (pre-clinical development, clinical development, and post-marketing).
• Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS.
• Demonstrated ability to influence decision making.
• Experience in adaptive clinical trials and innovative study designs.
• Experience in the utilization of Bayesian statistics in clinical trials.
• Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs.