Study Lead Statistician - Product Facing
Job Summary
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 should provide supervision and guidance to the Study Statistician. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include Regulatory activities, exploratory analyses, as well as publication/literature review and QCing publication work.
location: Telecommute
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's 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:
• Master's (Statistics/Biostatistics or related) + 4 years pharma/medical research stats experience OR PhD + 3 years experience.
• Strong statistical communication (written/oral).
• Strong understanding of clinical study design stats.
• Strong ability to apply statistical methods to clinical trials.
• Independent leadership of 1+ complex or multiple less complex studies.
• Experience developing protocols/SAPs, reviewing CSRs.
• Excellent English communication. Strong SAS/R skills for simulations and complex designs.
Preferred
• Master's + 6 years pharma/medical research stats experience OR PhD + 5 years experience.
• Experience designing, analyzing, and reporting clinical trials.
• Proven ability to present/defend statistical findings to internal/external audiences.
• Leadership of 3+ end-to-end clinical studies with minimal oversight.
• Life Cycle Drug Development experience.
• Demonstrated cross-functional teamwork (business solutions, study management, programming).
• Demonstrated ability to influence decisions.
• Experience with adaptive/innovative trial designs.
• Experience with Bayesian statistics in trials.
• Proficient R skills for simulations and complex designs.
skills: SOP, CRF, CSR, ADaM, CRFs, R Language, SDTM, ICSR (Individual Case Study Report)
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Job Summary
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 should provide supervision and guidance to the Study Statistician. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include Regulatory activities, exploratory analyses, as well as publication/literature review and QCing publication work.
location: Telecommute
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's 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:
• Master's (Statistics/Biostatistics or related) + 4 years pharma/medical research stats experience OR PhD + 3 years experience.
• Strong statistical communication (written/oral).
• Strong understanding of clinical study design stats.
• Strong ability to apply statistical methods to clinical trials.
• Independent leadership of 1+ complex or multiple less complex studies.
• Experience developing protocols/SAPs, reviewing CSRs.
• Excellent English communication. Strong SAS/R skills for simulations and complex designs.
Preferred
• Master's + 6 years pharma/medical research stats experience OR PhD + 5 years experience.
• Experience designing, analyzing, and reporting clinical trials.
• Proven ability to present/defend statistical findings to internal/external audiences.
• Leadership of 3+ end-to-end clinical studies with minimal oversight.
• Life Cycle Drug Development experience.
• Demonstrated cross-functional teamwork (business solutions, study management, programming).
• Demonstrated ability to influence decisions.
• Experience with adaptive/innovative trial designs.
• Experience with Bayesian statistics in trials.
• Proficient R skills for simulations and complex designs.
skills: SOP, CRF, CSR, ADaM, CRFs, R Language, SDTM, ICSR (Individual Case Study Report)
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
