Ph.D. or MS in Statistics or Biostatistics required.
4+ years (Ph.D.) or 6+ years (MS) experience in the Pharmaceutical/CRO industry.
Strong proficiency in SAS programming.
Deep understanding of ICH guidelines and CDISC data standards.
Strong organizational and time management skills for meeting deadlines.
Excellent communication skills for effective teamwork and interfacing.
Proven ability to work autonomously and solve problems.
Responsibilities
Review and design clinical trial protocols, including statistical sections and sample size calculations.
Oversee CRF and database design, including edit check specifications.
Monitor study quality and oversee statistical activities throughout the study.
Prepare and review statistical analysis plans (SAP), TFL shells, and variable specifications.
Collaborate with Statistical Programmers and Clinical Data Managers to resolve data quality issues.
Provide statistical support for analyses and interpretation of results drawing from datasets and TFL.
Review and contribute to study reports, manuscripts, and regulatory documents.
Benefits
Opportunity for professional growth in a leading pharmaceutical environment.
Collaborative work with cross-functional teams and external vendors.
Exposure to a variety of responsibilities within statistical and regulatory domains.
Flexibility to work independently, with leadership opportunities for CRO teams.
Engagement in meaningful work impacting drug development and regulatory success.
Full Job Description
Job Description: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Responsibilities:
Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
Review CRF, database design, and edit check specs.
Review study quality surveillance plan and monitor study conduct.
Prepare and/or review SAP, TFL shells and specifications for variable derivation.
Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables.
Provide statistical and validation support for statistical analysis, analysis datasets and TFL.
Review study report, manuscripts and other documents related to statistics.
Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents.
Perform other ad-hoc statistical activities as needed.
Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming.
Participates in monitoring CRO activities and reviewing CRO deliverables Other duties as assigned.
Requirements:
Ph.D. or MS in Statistics or Biostatistics.
Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience.
Excellent knowledge of SAS computer package.
Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines.
Excellent organizational skills, time management, and ability to meet established deadlines.
Excellent communication and interpersonal skills to effectively interface with others.
bility to work independently and problem-solve.
bility to provide leadership for the CRO statisticians and statistical programmers.
