Senior Biostatistics Project Manager

Placements24; Cape Town; Hybrid; ZAR 950,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary and bonuses

Comprehensive benefits

Remote work from anywhere

Job summary

Placements24 is seeking a Senior Biostatistics Project Manager for a fully remote role. You will lead biostatistics teams, develop SAPs, and ensure timely, regulatory-compliant analyses of clinical trial data across phases I–IV.

The ideal candidate holds a Master’s or Ph.D. in Biostatistics or related field, with 7+ years in biostatistics and 3+ years in project management, plus strong SAS/R proficiency and leadership skills.

Qualifications

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• 7+ years in biostatistics within pharma/CRO; at least 3 years in project management.
• Experience managing statistical aspects of clinical trials (Phase I–IV).
• Proficiency in SAS and R; strong programming skills.
• Knowledge of ICH guidelines and regulatory submissions.
• Strong leadership, communication, and cross-functional collaboration skills.

Responsibilities

• Lead biostatistics project teams for clinical trials from start-up to database lock and final reporting.
• Develop and manage SAPs with clinical teams.
• Oversee statistical programming activities ensuring standards and timelines.
• Manage budgets, resources, and timelines for biostatistics deliverables.
• Ensure quality and integrity of analyses and reports per regulatory standards.
• Serve as primary biostatistics contact for internal and external stakeholders.
• Identify and mitigate risks in biostatistics project execution.
• Mentor junior biostatisticians and programmers.
• Stay updated on advances in statistics and regulatory guidelines.

Skills

Leadership

Project management

Communication

Cross-functional teamwork

Problem solving

Education

Master's or Ph.D. in Biostatistics/Statistics or related field

Tools

SAS

R

Job description

About the Role

Our client, a renowned biopharmaceutical research organization, is seeking a highly skilled Senior Biostatistics Project Manager for a fully remote position. This role is central to ensuring the successful statistical analysis and reporting of clinical trial data, underpinning critical drug development decisions. Based remotely, you will lead project teams, manage timelines, and ensure the quality and integrity of statistical deliverables. The ideal candidate will possess a strong background in biostatistics, extensive experience in clinical trial project management, and a deep understanding of regulatory requirements. This position demands exceptional organizational skills, leadership acumen, and the ability to foster effective collaboration across distributed teams. You will play a pivotal role in advancing novel therapies from development through to regulatory approval.

Key Responsibilities

• Lead biostatistics project teams for clinical trials, from study start-up to database lock and final reporting.
• Develop and manage biostatistical analysis plans (SAPs) in collaboration with clinical teams.
• Oversee the statistical programming activities, ensuring adherence to standards and timelines.
• Manage project budgets, resources, and timelines for biostatistics deliverables.
• Ensure the quality and integrity of statistical analyses and reports, meeting regulatory standards.
• Act as the primary biostatistics point of contact for internal stakeholders and external clients.
• Identify and mitigate risks associated with biostatistics project execution.
• Contribute to the development and refinement of biostatistics SOPs and best practices.
• Mentor and guide junior biostatisticians and statistical programmers.
• Stay abreast of advancements in statistical methodologies and regulatory guidelines.

Requirements

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 7 years of experience in biostatistics within the pharmaceutical or CRO industry, with at least 3 years in project management.
• Proven experience managing statistical aspects of clinical trials, including Phase I-IV studies.
• Strong understanding of statistical analysis software (e.g., SAS, R) and programming.
• In-depth knowledge of ICH guidelines and regulatory requirements for statistical submissions.
• Excellent leadership, communication, and interpersonal skills.
• Proven ability to manage multiple complex projects simultaneously in a remote setting.
• Strong problem-solving and analytical skills.
• Experience with data visualization tools is a plus.
• Demonstrated ability to work effectively with cross-functional teams.

Benefits

• Our client offers a highly competitive salary, performance-driven bonuses, and a comprehensive benefits package including health, dental, and vision insurance.
• A generous retirement savings plan with employer matching is provided.
• This fully remote role offers unparalleled flexibility and the opportunity to work from anywhere.
• Professional development opportunities, including advanced statistical training and conference participation, are readily available.

Join a collaborative and innovative team driving the future of medicine from Cape Town, Western Cape, ZA.