For the past 20 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. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting. Don’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests. To change the language, click on "English" at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language. ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (domain@propharmagroup.com). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud. Are you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.
