Senior Principal Statistical Programmer

Katalyst Healthcares & Life Sciences

Newark, NJ
30+ days ago

Want to know if you’re a fit?
Upload your resume and let our AI show you.

Skills

Analysis Skillsunmatched
Biostatisticsunmatched
Biotech and Pharmaceuticalunmatched
Case Report Form (CRF)unmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Data Managementunmatched
Clinical Practices/Protocolsunmatched
Communication Skillsunmatched
Contract Research Organization (CRO)unmatched
Cross-Functionalunmatched
Data Qualityunmatched
Data Setsunmatched
Data Structuresunmatched
Database Designunmatched
FDA (Food and Drug Administration)unmatched
ICH Regulationsunmatched
Identify Issuesunmatched
Industry Standardsunmatched
Interpersonal Skillsunmatched
Leadershipunmatched
Licensingunmatched
Marketingunmatched
Organizational Skillsunmatched
Problem Solving Skillsunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
SAPunmatched
Statistical Programming Languagesunmatched
Statisticsunmatched
Surveillanceunmatched
Time Managementunmatched

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.
Ability to work independently and problem-solve.
Ability to provide leadership for the CRO statisticians and statistical programmers.

Numbers & Facts

Location

Newark, NJ

Resume Resources

Free Resume Templates Free Resume Builder