Study Lead Statistician - Product Facing

Job Summary Seeking a Study Lead Statistician - Product Facing to support late-stage clinical development programs within the specialty and rare disease portfolio of a leading global biopharmaceutical company. This fully remote role (with preference for candidates in the Eastern Time Zone) offers the opportunity to lead statistical strategy, design, and analysis for pivotal studies, contributing to regulatory and publication deliverables across a growing product line. The ideal candidate will have advanced training in Biostatistics, strong programming experience in SAS and/or R, and a proven record of success leading statistical activities for clinical studies. Key Skills: Biostatistics, Clinical Study Design, Statistical Programming (R / SAS), Clinical Study Protocol & SAP Development, Medical Publications Support, Data QC (ADaM, TLF), Regulatory Documentation. location: Telecommute job type: Contract salary: $90.00 - 113.05 per hour work hours: 9 to 5 education: Doctorate 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 I 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 • 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) • Support product-level publication request • 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 Company GCA and external bodies Qualifications Required: • Masters degree (MS) 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 • Masters (MS) 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 Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research • Designing, analyzing and reporting of clinical trials within Pharmaceutical / Biotechnology / Public Health setting in Industry, Government or Academia • 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 • 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 • Experience in publication support skills: SAS, CSR, ADaM, R Language, Statistical Analysis Plan, Medical Publications, QC Review, Clinical Study Report (CSR) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. u00006475229