Ph.D. or MS in Statistics or Biostatistics required.
4+ years experience in the Pharmaceutical/CRO industry for Ph.D. or 6+ years for MS.
Proficiency in SAS programming is essential.
In-depth knowledge of ICH guidelines, CDISC data structures, and FDA regulations.
Strong organizational and time management skills to adhere to tight deadlines.
Excellent communication skills for effective collaboration with stakeholders.
Proven ability to work independently and lead teams.
Responsibilities
Review protocols and prepare statistical sections for clinical trials.
Design study elements including sample size calculations and analysis methods.
Monitor study conduct and ensure quality through surveillance plans.
Prepare and review statistical analysis plans and specifications.
Collaborate with programming and data management teams to address data quality issues.
Support statistical validation and analysis for datasets and TFLs.
Review final reports, manuscripts, and provide large-scale regulatory support.
Engage with health authorities and manage complex statistical responses to requests.
Review CRO deliverables and ensure adherence to timelines.
Benefits
Opportunity for professional development and advancement.
Collaborative working environment with cross-functional teams.
Exposure to diverse statistical practices in clinical research.
Participation in regulatory submissions and interactions with health authorities.
Ability to influence the strategic direction of statistical analysis.
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.
