Senior Biostatistician

ProPharma; Raleigh (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProPharma is seeking a Biostatistician to lead statistical activities across clinical trials, from study design to reporting, in a collaborative, regulated environment.

The role requires expertise in SAS and R, CDISC SDTM/ADaM, and strong communication to partner with clinical operations, data management, regulatory affairs, and external partners. This is a hybrid Raleigh-based position with some remote days.

Qualifications

• Ph.D. or MS in Biostatistics with strong statistical knowledge.
• 3+ years of relevant work experience in outsourcing.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Experience with CDISC data structures (SDTM/ADaM).

Responsibilities

• Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
• Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.
• Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
• Participate in the development and review of clinical study protocols and CRFs for appropriate statistical analysis.
• Develop and maintain SAS programs for statistical analysis per SOPs and regulatory guidelines.
• Stay updated with regulatory guidelines and industry standards in biostatistics.
• Contribute to internal processes and SOPs to improve statistical efficiency.
• Provide guidance and mentorship to junior statisticians.
• Other duties as assigned.

Skills

Biostatistics

SAS programming

Project management

Regulatory knowledge

R programming

Education

Ph.D. in Biostatistics

M.S. in Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions

• Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
• Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.
• Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.
• Participate in the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.
• Develop and maintain SAS programs for statistical analysis in accordance with standard operating procedures (SOPs), good programming practices, and regulatory guidelines.
• Keep up to date with regulatory guidelines and industry standards related to biostatistics and ensure compliance with these guidelines.
• Participate in the development and maintenance of internal processes and standard operating procedures to improve statistical efficiency and consistency.
• Provide guidance and mentorship to junior statisticians.
• Other duties as assigned.

Necessary Skills And Abilities

• In-depth knowledge of statistical methodologies.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Knowledge of regulatory requirements and guidelines related to statistical analysis and reporting of clinical trial data.
• Ability to program in SAS and or R.

Educational Requirements

• Ph.D. in Biostatistics, or M.S. in Biostatistics.

Experience Requirements

• 3+ years of relevant work experience.
• Outsourcing industry experience required.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Experience with CDISC data structures, such as SDTM and ADaM.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.