Senior Biostatistician

Job Description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empower 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 :

1. Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
2. Provide statistical expertise to cross-functional teams, including clinical operations, data management, and regulatory affairs.
3. Ensure the quality and accuracy of statistical deliverables, including reports, tables, listings, and graphs.
4. Participate in the development and review of clinical study protocols and CRFs to ensure appropriate statistical analysis.
5. Develop and maintain SAS programs for statistical analysis according to SOPs, good programming practices, and regulatory guidelines.
6. Stay updated with regulatory guidelines and industry standards related to biostatistics and ensure compliance.
7. Contribute to the development and maintenance of internal processes and SOPs to improve statistical efficiency and consistency.
8. Provide guidance and mentorship to junior statisticians.
9. Other duties as assigned.

Necessary Skills and Abilities :

• In-depth knowledge of statistical methodologies.
• Excellent communication and interpersonal skills for collaboration with cross-functional teams and external partners.
• Strong project management skills to handle multiple projects simultaneously.
• Knowledge of regulatory requirements for statistical analysis and reporting of clinical trial data.
• Proficiency in programming with SAS and/or R.

Educational Requirements:

• Ph.D. or M.S. in Biostatistics.

Experience Requirements:

• At least 3 years of relevant work experience.
• Experience in outsourcing industry required.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Knowledge of 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. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails regarding this posting.***