Pharmaceutical Biostatistician

Placements24; Queenstown; Hybrid; NZD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Health and wellness benefits

Retirement savings plan

Professional development opportunities

Job summary

Placements24 in Queenstown is seeking a highly skilled Pharmaceutical Biostatistician to lead design, analyses, and regulatory support for clinical trials in a hybrid on-site/remote setting.

You will work with cross-functional teams, develop Statistical Analysis Plans (SAPs), perform analyses in SAS and R, and communicate results to statisticians and non-statisticians. A strong regulatory and trial-design foundation is required.

Qualifications

• Master's degree or PhD in Statistics, Biostatistics, or a related quantitative field.
• 4+ years of biostatistics experience in pharma/biotech environment.
• Proficiency with SAS, R, or SPSS and strong regulatory knowledge.

Responsibilities

• Design clinical trial protocols with robust statistical methods and sample sizes.
• Develop SAPs outlining endpoints for studies.
• Perform statistical analyses using SAS or R.
• Interpret results and communicate insights to teams.
• Prepare CSRs and regulatory submission documents.
• Collaborate with data management to ensure data integrity.
• Consult with investigators on statistical matters.
• Stay current with regulatory guidelines and methods.
• Present findings at meetings or conferences.
• Contribute to research strategy and evaluation of new candidates.

Skills

Statistical analysis

Clinical trial design

Data interpretation

Analytical thinking

Communication skills

Education

Master's degree in Statistics or Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

SPSS

Job description

About the Role

Our client, a leading pharmaceutical research organization dedicated to advancing medical science, is seeking a highly skilled Pharmaceutical Biostatistician to join their innovative team in Queenstown, Eastern Cape . This role is integral to the design, execution, and analysis of clinical trials, ensuring the integrity and validity of study results. The Biostatistician will work closely with clinical development, data management, and regulatory affairs teams to develop statistical analysis plans, perform data analysis, and interpret results for regulatory submissions and publications. This position offers a significant opportunity to contribute to the development of novel therapies that improve patient lives. The role features a Hybrid work model, blending on-site collaboration with remote flexibility.

Key Responsibilities

• Design clinical trial protocols, ensuring robust statistical methodologies and appropriate sample sizes.
• Develop Statistical Analysis Plans (SAPs) for clinical studies, outlining primary, secondary, and exploratory endpoints.
• Perform statistical analyses of clinical trial data using SAS, R, or similar statistical software.
• Interpret statistical results and translate them into clinically meaningful insights.
• Prepare statistical reports and contribute to clinical study reports (CSRs) for regulatory submissions.
• Collaborate with data management to ensure data quality and integrity.
• Consult with investigators and clinical research teams on statistical matters.
• Stay current with statistical methodologies, software advancements, and regulatory guidelines in the pharmaceutical industry.
• Present statistical findings at internal meetings and potentially at scientific conferences.
• Contribute to the development of research strategies and the evaluation of new drug candidates.

Requirements

• Master's degree or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• A minimum of 4 years of experience in biostatistics within the pharmaceutical or biotechnology industry.
• Proficiency in statistical analysis software such as SAS, R, or SPSS.
• Strong understanding of clinical trial design, statistical principles, and regulatory requirements (e.g., ICH guidelines).
• Experience with various statistical methods relevant to clinical trials, including survival analysis, regression modeling, and longitudinal data analysis.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to explain complex statistical concepts to non-statisticians.
• Ability to work effectively in a Hybrid work environment in Queenstown, Eastern Cape .
• Detail-oriented and committed to producing high-quality, accurate work.
• Experience with data visualization tools is a plus.

Benefits

Our client offers a competitive salary, comprehensive health and wellness benefits, and a retirement savings plan. We provide excellent opportunities for professional development, including access to advanced training and conferences. Employees benefit from a collaborative research environment, cutting-edge technology, and the satisfaction of contributing to life-changing medical advancements. This role is based in Queenstown, Eastern Cape , offering a unique opportunity to contribute to global health from a vibrant regional center.