Senior/Principal Biostatistician

Planet Pharma Group; New Jersey; Hybrid; USD 120,000 - 170,000; Full time

Job summary

Planet Pharma seeks a Senior Biostatistician for our Bridgewater, NJ or remote work from anywhere in the USA. You will lead statistical planning, analysis, and reporting for pivotal clinical trials, and contribute to SAPs, data standards, and publication efforts.

The role requires advanced biostatistics expertise, project leadership, and collaboration with data management to ensure high-quality deliverables and timely CSR submissions.

Qualifications

• PhD in statistical science or related field with 2 years relevant experience, or a Master’s with 4 years relevant experience.
• Strong background in statistical methods for design, analysis and reporting of clinical trials.
• Experience writing SAPs and contributing to protocol sections.

Responsibilities

• Lead statistical and programming operations to ensure quality and on-time delivery.
• Provide statistical design, analysis and reporting for clinical trials and research projects.
• Write SAPs and manage QC/QA plans for projects.
• Develop ADaM dataset specifications and review SDTM specifications.
• Perform data validation and prepare statistical reports for CSR and publications.
• Collaborate with data management and trial teams to ensure data quality and timely database lock.

Skills

Leadership

Project management

Statistical analysis

Biostatistics

Clinical trial design

SAP writing

Education

PhD in statistical science or related field

MS in statistics or related field

Tools

SAS

R

ADaM

SDTM

Job description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team asSenior Biostatisticiansfor our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Key Accountabilities:

1. Leadership and Project Management:

1. Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations.
2. Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on time delivery of deliverables, earn client’s trust and repeat business.

2. Statistical Planning and Methodologies:

1. Provide statistical expertise for design, analysis and reporting of clinical trials and research projects.
2. Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.
3. Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments.
4. Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects.
5. Provide input to unblinded data management plan when required.
6. Assist in research and development of statistical methodologies and processes.

3. Statistical Programming:

1. Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required.
2. Perform QC validation of analysis datasets and TLGs.
3. Perform third level review of dry runs and final run.
4. Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues.
5. Review and provide input to the Analysis Data Reviewer’s Guide, discuss and incorporate Data Standards Reviewer’s review comments to ensure quality of the document.

4. Statistical Analysis and Reporting, and Publication Support:

1. Perform statistical analysis as per SAP, and address peer/QC review comments and findings.
2. Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
3. Plan and conduct or contribute to the trial results reporting/dissemination meetings.
4. Under supervision contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results.
5. Write statistical report or statistical sections of the CSR.
6. Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters.

5. Supporting Clinical Data Collection and Cleaning:

1. Provide statistical input to Case Report Forms (CRF) design and database/variable structure.
2. Provide statistical input to non-CRF data collection and acquisition methods and approaches.
3. Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification.
4. Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
5. Perform ongoing assessment and communication of data quality issues, including protocol deviations.
6. Assist data management and trial management team in preparing for database lock.

6. Complete job required and project-specific training. Comply with applicable Everest and trial sponsor’s policies, SOPs, and work instructions.

7. Properly archive study files in accordance with trial sponsor’s requirements.

8. Plan and carry out professional development activities.

Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis or related fields plus 2 years highly relevant experience or a Master’s degree plus 4 years highly relevant experience, with demonstrated ability and sustained performance.