Biostatistician Early Phase (Remote)

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

The Biostatistician applies statistical expertise across clinical research projects independently supporting or leading studies performing statistical analyses and delivering high-quality statistical documents and outputs in support of sponsors clinical development programs.

The ideal candidate has strong applied biostatistics experience and proficiency in SAS and R including tables figures and listings (TFLs) inferential analyses and randomization. This individual will collaborate with Statistical Programming Data Management Clinical and other cross-functional teams while independently contributing to statistical deliverables and quality review.

Experience supporting Phase 1 and early clinical development studies is strongly preferred including familiarity with early-phase study designs safety and tolerability endpoints pharmacokinetic/pharmacodynamic (PK/PD) data dose escalation and exploratory analyses.

Responsibilities

• Follow company SOPs templates processes and policies.
• Serve as the study Biostatistician for assigned clinical trials and statistical point of contact for internal teams and clients as appropriate.
• Provide statistical input into study design protocols project timelines and clinical development activities.
• Review clinical study protocols and provide statistical recommendations.
• Develop randomization schedules using SAS R or other validated software as applicable.
• Develop perform and QC statistical analyses for clinical studies.
• Develop or contribute to Statistical Analysis Plans (SAPs) including TFL specifications and shells.
• Develop and review summary statistics inferential analyses TFLs and graphical displays.
• Support analyses of safety tolerability PK/PD and other clinical endpoints as applicable.
• Use SAS R and other statistical tools to perform or validate analyses and results.
• Review programming outputs for accuracy and consistency with protocols and SAPs.
• Perform QC review of statistical analyses specifications outputs and documents.
• Collaborate with Statistical Programming Data Management Clinical Medical and other teams to ensure timely accurate delivery of study outputs.
• Represent Biostatistics in client study team and cross-functional meetings.
• Support regulatory submissions and responses to regulatory questions as needed.
• Conduct work in accordance with SOPs GCP and applicable regulatory guidelines.
• Maintain knowledge of applicable regulatory requirements and guidance including FDA EMA ICH and GCP.
• Participate in process and quality improvement initiatives as appropriate.
• Perform other duties as assigned.

Education

• Masters degree in Statistics Biostatistics or a related quantitative field required.

Core Competencies

• Excellent written and verbal communication skills.
• Ability to communicate effectively with cross-functional teams regarding timelines deliverables statistical considerations and issues.
• Strong interpersonal skills and a collaborative client-focused approach.
• Ability to work independently and effectively within a team.
• Strong organizational and prioritization skills with high attention to detail.
• Flexibility in managing changing priorities and study requirements.
• Understanding of the clinical research lifecycle and applicable regulations.
• Proficiency with Microsoft Word Excel and PowerPoint.

Statistical & Technical Skills

• Ability to support or own statistical deliverables from study design through analysis and reporting.
• Proficiency in SAS and R including statistical programming data analysis and inferential statistical methods.
• Experience developing and reviewing SAPs and TFL specifications and shells.
• Ability to review statistical programming outputs for accuracy and alignment with study specifications and SAPs.
• Experience reviewing clinical study protocols.
• Familiarity with aCRFs eCRFs and clinical data structures.
• Working knowledge of CDISC standards including SDTM and ADaM.
• Ability to review SDTM and ADaM datasets and specifications from a statistical perspective.
• Experience with Phase 1 or early-phase clinical trials preferred.
• Familiarity with early-phase analyses including safety tolerability PK/PD dose escalation and exploratory endpoints preferred.