Senior Principal Statistical Programmer

Katalyst CRO; Newark (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO in the United States is seeking a Senior Manager in Statistics to lead statistical activities across clinical trials from protocol development to final study report and in-licensing activities.

The role requires a Ph.D. or MS in Statistics or Biostatistics, hands-on SAS expertise, and leadership to guide CRO statisticians and programmers while ensuring compliance with ICH, CDISC, and FDA guidelines.

Qualifications

• Ph.D. or MS in Statistics or Biostatistics is required.
• Experience in pharmaceutical/CRO settings is required.
• Strong knowledge of SAS and regulatory guidelines (ICH, CDISC, FDA) is essential.

Responsibilities

• Review protocols and design study elements including sample size calculations and analysis methods.
• Review CRFs, database design, and edit check specs.
• Provide statistical and validation support for analyses and datasets.
• Lead CRO statisticians and statistical programmers and supervise deliverables.
• Prepare SAP, TFL shells and specifications for variable derivation.
• Respond to health authority requests with appropriate statistical inputs.

Skills

Statistical leadership

Clinical trials design

SAS programming

Regulatory guidelines

Cross-functional collaboration

Education

Ph.D. in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

SAS

Job description

Job DescriptionThe 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.

Job DescriptionThe 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.