Pharmaceutical Biostatistician

Placements24; Soweto; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Fully remote work

Medical plan

Retirement savings plan

Generous paid vacation

Professional growth

Job summary

Placements24 is seeking a highly analytical Pharmaceutical Biostatistician to join a remote Biostatistics team. The role focuses on trial design, analysis, and regulatory reporting across the drug development lifecycle, collaborating with scientists and data managers to ensure data integrity.

The ideal candidate has an academic background in statistics/biostatistics, strong programming skills in SAS or R, and a collaborative mindset for global health outcomes in a flexible remote setting.

Qualifications

• Master's or PhD in Statistics, Biostatistics, or related field.
• 3–5 years of biostatistics experience in pharma/biotech with clinical trials.
• Proficiency in SAS or R is essential; experience with SPSS or Stata is a plus.

Responsibilities

• Design clinical trial protocols with appropriate statistical methods for efficacy and safety.
• Develop SAPs and TFLs for CSR reports.
• Perform statistical analyses using SAS/R/SPSS and interpret results.
• Support regulatory submissions (e.g., IND, NDA, BLA) with statistics insights.
• Collaborate with clinical operations and data management to ensure data quality.
• Review CRFs and database specs from a statistical perspective.
• Develop and validate statistical programs and algorithms.
• Stay updated on regulatory guidelines and methodologies.
• Communicate findings clearly to diverse audiences.
• Participate in DMCs and provide statistical expertise.

Skills

SAS

R

Bayesian methods

Survival analysis

Biostatistics

Education

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

Tools

SAS

R

SPSS

Stata

Job description

About the Role

Our client, a leader in pharmaceutical research and development, is seeking a highly analytical and skilled Pharmaceutical Biostatistician to join their dynamic Biostatistics team. This fully remote position offers the opportunity to contribute to crucial clinical trial design, analysis, and reporting, ensuring the integrity and validity of data that supports regulatory submissions and medical advancements. You will work closely with clinical scientists, data managers, and regulatory affairs professionals to provide statistical expertise throughout the drug development lifecycle. The ideal candidate possesses a strong academic background in statistics or biostatistics, proficiency with statistical software, and a keen eye for detail. We are looking for a collaborative individual who can translate complex statistical concepts into actionable insights and contribute to bringing innovative therapies to patients worldwide. This role offers significant career growth potential within a company dedicated to improving global health outcomes through rigorous scientific research and development, all within a flexible remote work setting.

Key Responsibilities

• Design clinical trial protocols, ensuring appropriate statistical methodologies are employed for efficacy and safety endpoints.
• Develop statistical analysis plans (SAPs) and detailed tables, figures, and listings (TFLs) for clinical study reports.
• Perform statistical analyses of clinical trial data using appropriate statistical software (e.g., SAS, R, SPSS).
• Interpret statistical results and provide statistical support for regulatory submissions (e.g., IND, NDA, BLA).
• Collaborate with clinical operations and data management teams to ensure data quality and integrity.
• Review Case Report Forms (CRFs) and database specifications from a statistical perspective.
• Contribute to the development and validation of statistical programs and algorithms.
• Stay current with advancements in statistical methodologies and regulatory guidelines relevant to pharmaceutical development.
• Communicate statistical findings clearly and effectively to both statistical and non-statistical audiences.
• Participate in data monitoring committees (DMCs) and contribute statistical expertise.

Requirements

• Master's or Ph.D. degree in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum of 3-5 years of experience as a biostatistician in the pharmaceutical or biotechnology industry, with a focus on clinical trials.
• Proficiency in statistical programming using SAS or R is essential.
• Strong understanding of clinical trial design principles, statistical inference, and survival analysis.
• Experience with regulatory requirements and guidelines from agencies like the FDA and EMA.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to present complex statistical information effectively.
• Ability to work independently and collaboratively in a remote team environment.
• Familiarity with statistical software packages like SPSS or Stata is a plus.
• Experience with Bayesian statistical methods is desirable.

Benefits

• Our client offers a highly competitive salary, commensurate with experience and qualifications, plus a performance-based bonus structure.
• Comprehensive benefits include a fully covered medical plan, retirement savings plan, and generous paid vacation.
• Opportunities for professional growth and development include access to advanced training, conferences, and potential for career advancement within the biostatistics department.
• The fully remote work arrangement offers exceptional flexibility and work-life balance.
• Contribute to the critical analysis that drives the development of life-changing medicines from the convenience of your home office.
• A culture that values scientific rigor, collaboration, and employee well-being is central to our operations.