Senior Biostatistician – Clinpharm

This is a fully remote position, open to applicants in India.

📋 Description

• Evaluate Statistical Analysis Plans (SAPs) to ensure alignment with protocols and regulatory standards

• Create mock shells and outline analysis datasets

• Assist with randomization processes

• Conduct protocol assessments and provide statistical insights during study design and implementation

• Review Clinical Study Reports (CSRs) to verify the accuracy and consistency of statistical results

• Aid in Phase I studies, encompassing PK/PD analyses, biomarker assessments, and clinical pharmacology evaluations (Phase 1A, 1B, and 2A)

• Validate Tables, Listings, and Figures (TFLs) to guarantee adherence to quality standards

• Utilize CDISC standards (SDTM/ADaM)

• Collaborate with statistical programming teams

• Utilize SAS for statistical analyses and data review tasks

• Proactively challenge the status quo within a competitive and evolving landscape

⛳️ Requirements

• 5–8 years of experience as a Senior Biostatistician

• Proficient in reviewing Statistical Analysis Plans (SAPs) in accordance with protocols and regulatory standards

• Skilled in developing mock shells and defining analysis datasets

• Experienced in randomization activities

• Proven ability to perform protocol reviews and offer statistical contributions during study design and execution

• Familiarity with reviewing Clinical Study Reports (CSRs)

• Background in supporting Phase I studies, including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments (Phase 1A, 1B, and 2A)

• Experience in validating Tables, Listings, and Figures (TFLs)

• Knowledge of CDISC standards (SDTM/ADaM)

• Proficient in SAS for statistical analyses and data review tasks

• Equivalent experience, skills, and/or education may be taken into account

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged management

• Training in technical and therapeutic areas

• Recognition among peers

• Comprehensive total rewards program

• Inclusive workplace culture

• Reasonable accommodations available for employees or applicants with disabilities, when necessary