Principal/Senior Biostatistician

About the Role

Greetings for the day. Hope you are doing well!! **About Company:** GENINVO is the go\-to partner for those looking to better leverage technology in the life science industry. Our expertise in life sciences, leading\-edge technologies, and software development enables us to provide innovative and transformative solutions and services to our sponsors. Our mission is to help revolutionize the industry to bring life\-changing treatments to patients faster. We have locations in USA, Canada, Europe, UK, and India. Our global reach allows us to work with our clients as strategic partners rather than as just a vendor. We continuously invest in technologies to optimize services and solutions GENINVO had been established as an independent organization after being carved out of its parent company (a Biometric focused CRO) that put us in a niche position where we gained the experience in providing technology\-focused services and working dedicatedly on enabling automation for the same. Our delivery of fit\-for\-purpose software solutions and services, and our commitment to identifying and addressing our clients’ needs, has made us known as a trusted advisor and strategic partner to our clients. Our handpicked product teams are the right mix of technology experts and life\-science SMEs, which brings a unique approach at problem\-solving for the pharmaceutical industry. Our clients rely on us for complete transparency solutions, and we achieve excellence in clinical trials by offering automation tools such as DocQC, Shadow, Data Transformation Package, ApoGI and many more to come as we move ahead. GenInvo’s strength is in our implementation of technology, clinical technology, and our people. We also extend our services for data transformation, metadata management and development of custom applications tailored towards clients’ specific requirements. Our mission is to be the go\-to partner for our clients and an industry leader in Life Sciences. GenInvo’s vision is the digitalization of the pharmaceutical industry **Brief Role and Responsibilities:** **Position: Senior/Principal Biostatistician** **Location: Remote (US \& Canada)** **Duration: Fulltime** **Experience: 6\-15 years** **Education Requirements: BA/BS/M.Sc. or international equivalent degree in Statistics/Mathematics/Biostatistics** **Technical Skills Requirements** * Experience in writing statistical documents like stats part of Protocol, statistical analysis plan (SAP) and statistical report. * Knowledge in programming languages such as SAS, basics of R etc. * Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). * Good knowledge of industry standards, including CDISC data structures like SDTMs, ADaMs etc. and an understanding of developing and utilizing standard programs. * Pharmaceutical/CRO experience as a Statistician supporting clinical trials for regulatory submissions. **Experience requirements:** * Minimum 5 years of work experience as a Biostatistician, preferably in a CRO or in the pharmaceutical industry. * Good knowledge of study design, statistical analysis, regulatory guidelines and programming techniques in SAS; must be able to apply them efficiently. * Experience as a biostatistician supporting all statistical activities through all phases of clinical trials. * Ability to clearly describe statistical techniques and interpret results. * Be diligent, meticulous and quality focused. * Demonstrated proficiency in communication and negotiation, proficient at collaborating effectively with others globally and exerting influence. * Lead statistical analysis activities and collaborate with cross functional teams and ensure timely and efficient delivery of statistical outputs as per the clients’ need. * Prepare or oversee development of statistical activities like Stats section of Protocol, Sample size determination, Statistical analysis plan, stats outputs and report and regulatory submissions/interactions, safety reports, publications, post\[1]marketing activities or other exploratory analyses (as required) * Stay current with new technologies and methods used in clinical research. * Provide mentorship and coaching on the technical aspects to the team * Manage resource allocation and workload within the team ensuring effective sharing of resources between groups to achieve company objectives and priorities as applicable. * Act as subject matter expert (SME) or as designated, lead process improvement and non\-clinical project initiatives, emphasizing statistical analysis reporting procedures. * Provides statistical programming support as needed. * Ensure adherence to company, department, and industry standards and processes. Foster innovation in statistical analysis and facilitate the development and efficient implementation of statistical solutions, while promoting knowledge sharing within/across the team. * Present or participate as a technical expert at external conferences or groups on statistical aspects. * Maintain comprehensive documentation of statistical documents, validation activities, and statistical analyses for regulatory submissions and audits. *If interested, kindly share your resume at himanshi.g141@geninvo.com with following information and we ll get back to you for further discussion on it:* * Full Name: * Contact Details: * E\-mail ID: * Current salary: * Expected Salary * Joining Time Required (Notice Period): * Current Company: * Current Location * Preferred Location: * Total Experience: * Legal Status: * Willingness to travel (in percentage 100%): * Convenient time to schedule the Interview. * Reason for Job Change: * LinkedIn ID: With Best Regards, **Himanshi Gupta** Pay: From ₹2,000,000\.00 per year Work Location: Remote