529 Biostatistics Jobs - Page 22

We are seeking an experienced and collaborative Senior Statistician to provide advanced statistical expertise and leadership in support of clinical research studies. This role involves working closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and sponsor teams to ensure the accuracy, reliability, and regulatory compliance of statistical deliverables. The Senior Statistician will also oversee quality control processes and contribute to the development of statistical analysis plans and datasets. Key Responsibilities: Provide statistical leadership and support for clinical trials, ensuring high-quality deliverables. Participate in cross-functional study-related activities and team meetings. Perform sample size calculations and author or review statistical analysis plans (SAPs) . Coordinate with Biostatisticians, Statistical Programmers, and Data Managers to prepare, conduct, and review statistical analyses. Ensure the accuracy and integrity of final statistical outputs and deliverables. Guide and supervise programmers in developing analysis dataset specifications and programming/validation of tables, listings, and figures (TLFs) . Validate analysis variables and statistical outputs for consistency and compliance. Conduct quality control (QC) of data displays and analysis datasets prepared by others. Maintain project administration files including protocols, annotated CRFs, SAPs, annotated shells, programming/QC rules, tracking logs, and communications. Participate in internal meetings and contribute to Biostatistics and Development Team initiatives. Primary Skills: Statistical Methodology: Advanced statistical techniques, sample size estimation, inferential statistics Programming: Proficiency in SAS and clinical data analysis tools Documentation: SAPs, annotated shells, QC logs, and regulatory documentation Collaboration: Cross-functional teamwork with clinical, data, and sponsor teams Leadership: Project management and mentoring of junior team members Secondary Skills: Regulatory Knowledge: Understanding of drug development and submission processes Quality Assurance: QC of datasets and statistical outputs Communication: Clear and effective communication with technical and non-technical stakeholders Project Organization: File management, version control, and audit readiness Software Proficiency: MS Word, Excel, PowerPoint, and project management tools Preferred Qualifications: Masters degree in Statistics or related field with 6+ years of industry experience PhD in Biostatistics or related field with 3+ years of postgraduate experience Proven ability to lead projects and manage cross-functional teams Strong foundation in statistical methodologies and SAS programming Experience with clinical trial data analysis and regulatory submissions Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications. 1. Applies scientific methods to analyse and solve software engineering problems. 2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance. 3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers. 4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities. 5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Roles & Responsibilities: Ensure that high quality bio statistical and psychopharmacology support is provided by the Analytics team Ensure that staff implement innovative, rigorous bio statistical methods to meet study objectives Lead RWE (Real World Evidence) large scale analytics (LSA) studies. Run statistical programs in R, R shiny, deploy study packages and generate reliable RWE results in TFLs with minimal supervision. Provide statistical support for design, implementation, running, analysis and dissemination of results for clinical trials Design and analyze clinical research projects Create and execute Statistical Analysis Plans Strong Knowledge in RWE(Real World Evidence) with Bio statistics Background Experience in creating cohort analysis or Meta analysis or Survival analysis or Bayesian Versus Frequentest Approaches to Clinical Trials Experience in implementing generalized mixture models, Bayesian mixer models, Fixed-effects and Random-effects models Knowledge on Statistical Process Control, Stochastic Optimization Knowledgeable in R or Python programming Skills and shiny web app development Knowledge on Cloud platform like AWS Exposure to Healthcare data formats like HL7, OMOP, ODHSI Exposure to RWE, RWA, RWD Experience with data sources like registries, EMR Good communications Skills

Job Location : Lucknow Role & responsibilities 1. Design and implement statistical models and methods to analyze clinical and laboratory data. 2. Interpret results to provide actionable insights that drive diagnostic test development and improvement. 3. Collaborate on experiment and clinical study design, ensuring appropriate statistical methodologies. 4. Perform statistical validation of diagnostic tests (sensitivity, specificity, predictive values). 5. Prepare detailed reports and presentations on statistical analyses. 6. Develop and maintain databases, ensuring data integrity and quality. 7. Collaborate with cross-functional teams to provide statistical support. Preferred candidate profile 1. Bachelor's degree in statistics, biostatistics, mathematics, or a related field. 2. Proficiency in Python or R. 3. Experience with SQL. 4. Strong Excel skills. 5. Familiarity with Tableau or Power BI. 6. Excellent problem-solving abilities. Preferred Qualifications: Masters degree in statistics, biostatistics, or a related field. - Experience in diagnostic test development or related field. - Knowledge of regulatory standards and guidelines (e.g., CLSI, FDA). - Strong communication and interpersonal skills Please Note : Those who have completed B.Sc in Mathematics and an M.Sc in Mahematics are the one eligible to apply. Candidates those who are seeking job opportunities in Lucknow will be preferable.

To accomplish this, it is necessary for the Senior Director to excel in high quality operational excellence, problem-solving, leadership behaviors across the teams to create a highly engaged motivated workforce and deliver results. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Enabling GSS Deliverables Provide strategic direction and oversight for GSS at LCCI Be a leader both within GSS and across R&D, contributing to cross-functional initiatives and influencing the field as applicable Partner closely with GSS and local Associate VP/VPs to effectively plan, forecast, and manage the resources required to deliver all projects Drive efficiency and continuous improvement within LCCI and across GSS to support therapeutic area and Business Unit aligned deliverables Statistical and Analytical Capabilities Development Establish deep technical capabilities at LCCI with supervision of direct reports and a total staff comprised of diverse skill set accountable for hands-on statistical activities Develop strategies and build capabilities and expertise within the team catering to advanced statistical capabilities Build-up, maintain and foster deep therapeutic, scientific excellence and environmental expertise to ensure accountability and proactive ability to deliver specific business needs Facilitate appropriate staff interactions with academic and professional external organizations Use national and international network of experts to address specific scientific questions across phases; leveraging and supporting the global stats network in order to speed innovation Site Leadership and Partnership Drive strong partnership and engage with Site Leadership, LRL at LCCI and other functional groups to support site strategy and effectiveness Partner closely with the GSS team at Cork as well as the GSS leadership at the Lilly Corporate Center to drive efficiency, continuous improvement, and investigate opportunity at all site(s) Enterprise Leadership Within functional and cross-functional teams, exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs Maintain awareness of external environment through benchmarking, external collaborations, contacts and professional organization involvement, and represent GSS at appropriate internal and external venues Accountable for fiscal responsibility of GSS at LCCI Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations Drive continuous improvement of key performance metrics Drive shared learning and process expertise between teams within the organization People Management and Development Provide leadership and development for direct reports Recruit, develop, and retain a strategic and operationally capable workforce skilled and knowledgeable in statistical methods and analytical thinking Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio Build an organizational culture that fosters inclusion and innovation. Create an environment that fosters professional and career development. In partnership with line management, develop the team s expertise in drug development, therapeutic area science, strategic thinking, project management and leadership Minimum Qualification Requirements: Ph.D. in Statistics/Biostatistics Minimum of 15 years of industry experience 7 years of supervisory experience; 5 years as a leader of leaders preferred Broad knowledge of the drug development process which includes industry requirements, quality expectations, and practices. Ability to develop and implement strategies across people, processes, organizations and technology. Ability to partner and influence across matrixed organization and collaborate with peers locally and globally Ability to communicate clearly and succinctly with all audiences and forums through strong oral and written communication Proactively identifies issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Demonstrated success in leading teams effectively Other Information/Additional Preferences: Minimum travel expected (10%)