4 Biostatistician Jobs

Biostatistician: One of the leading lifescience company in India manjeet.kaur@mounttalent.com whatsapp at 8384077438 PAN India Experience Required : 7 12 Years of experience Job description: Deliver statistical expertise and knowledge to internal and external stakeholders. Understand research papers and implement in ongoing studies. Knowledge of latest trends in the statistical research in the clinical trials domain. Review and take responsibility for all the deliverables to external stake holders. Support programming team in understanding the concepts and provide solutions. Communicate between internal and external teams and different departments. Meet project timelines with quality Compliance to regulatory requirements. Provide department level trainings. Guide in preparing and presenting statistical papers in Indian and International conferences. Experience in designing the CRF and input to protocol. Experience in writing SAP/RAP, dataset specifications and mock shells. Knowledge on CDISC standards Review of tables, listings, figures and interpret the results Abale to write clinical study reports and statistical reports for submissions Experience in oncology and other major therapeutic areas Experience in programming in SAS/R Experience in handling submission studies, ISE and ISS. Being adaptable and flexible when priorities change. Strong QC/validation skills. Proficiency in efficacy analysis. Bachelors degree/ Masters/PhD in one of the following fields Statistics, Computer Science, Mathematics, etc.

Role & responsibilities : Collaborating with cross-functional teams (e.g., clinical researchers, medical experts, data scientists) to design clinical studies and research protocols. Developing statistical analysis plans (SAP), including the identification of primary and secondary endpoints, sample size calculations, and statistical methodologies. Ensuring statistical methods are aligned with regulatory requirements and industry standards, especially in clinical trials. Providing expertise on randomization techniques and adaptive designs. Leading the analysis of complex datasets, including data from clinical trials, epidemiological studies, and observational studies. Ensuring proper data cleaning, transformation, and validation processes are followed to guarantee the integrity of the data. Using advanced statistical software and techniques (e.g., R, SAS, STATA) to perform statistical modeling (e.g., regression models, survival analysis, mixed models). Analyzing and interpreting results, ensuring conclusions are scientifically sound, and communicating findings in a clear, concise manner. Developing and applying advanced statistical methodologies and techniques tailored to specific study needs, such as longitudinal analysis, survival analysis, or Bayesian methods. Assessing and adapting statistical methods as necessary based on emerging data or evolving study designs. Participating in regulatory meetings and discussions, providing statistical justification for study results and approaches. Mentoring and providing guidance to junior biostatisticians and other team members on statistical methodologies, software, and best practices. Developing training materials and conducting workshops on statistical topics for internal teams and collaborators. Ensuring statistical methods and processes are consistent with industry best practices and organizational standards. Conducting quality control procedures on statistical analyses to verify results and ensure accuracy and validity. Preparing statistical reports, manuscripts, presentations, and posters for scientific journals, conferences, and internal stakeholders. Clearly presenting complex statistical results to non-statistical audiences (e.g., clinical or regulatory teams), ensuring the results are understood and actionable. Working closely with other teams, including clinical researchers, project managers, and data scientists, to ensure the alignment of statistical analyses with research objectives. Actively participating in meetings, strategy sessions, and research reviews to provide statistical insights that can influence study direction and design. Translating statistical findings into actionable recommendations for decision-making. Ensuring that statistical analyses comply with ethical standards and regulatory requirements (e.g., Good Clinical Practice (GCP), Good Statistical Practice (GSP)). Supporting the development of ethical guidelines for statistical methodologies, including ensuring patient safety and data confidentiality. Additional Skills: SAS Programming R Programming (Optional) Advanced knowledge of biostatistics, including statistical theory, methods, and applications. Proficiency in statistical software such as SAS, R, and STATA. Strong communication skills, especially in translating complex statistical concepts into practical recommendations. Attention to detail and the ability to ensure the quality and accuracy of analyses. Experience with clinical trials and regulatory submissions is often critical Qualifications: Master's Degree (Preferred): A Master's in Biostatistics, Statistics, Public Health, or a related field is commonly required for many biostatistician roles, especially in CRO, research institutions, pharmaceutical companies, or public health organizations

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area. Location: Home-based What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells. Performs quality control (source code review, double-programming and log review) of SAS programs. Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications. Prepares specifications for CDISC and other analysis data sets. Assists Data Management with SAS programming needs. Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team. Develops and validates general SAS macros. What we are searching for: BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role. 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.

What you'll be doing Create, test and maintain SAS codes used to create and/or validate statistical outputs for the cardiac safety statistical analysis; create and maintain procedures for creation of TFLs/ statistical outputs; provide statistical support under the supervision of senior team resources and/or department management; may supervise staff in a line management or matrix capacity. Develop, test, execute and maintain SAS and R programs for statistical analysis including central tendency analysis, categorical analysis, and concentration-QTc analysis Validate results of statistical analysis by double programming Prepare tables, figures, and listings for statistical analysis as outlined in the statistical analysis plan Perform review of final outputs and reports as it relates to the planned statistical analysis Perform quality checks on CDISC formatted analysis datasets (ADaM) Support research programs and provide research results to the senior team resources and/or department management Provide interpretation of results/reports of statistical analysis including descriptions of methodologies and conclusions to the Principal/Sr. Principal Biostatistician, Medical Writing, and/or Scientific Team Train team members on standard operating procedures and standard methodology Develop process improvements to increase overall operational efficiency Drive ideas for future analyses and data quality efforts What we're looking for A PhD in Statistics, Mathematics or equivalent A Masters degree in Statistics, Mathematics or equivalent and 4+ years of relevant industry experience Bachelor’s degree in Statistics, mathematics or equivalent with 10+ years of relevant industry experience. Familiarity and experience with ANOVA, t-test, regression, and linear mixed-effects modeling. Strong SAS or R programming skills. Experience in clinical trials within a CRO or pharmaceutical research organization Familiarity with Clinical protocols and Statistical Analysis Plans, understanding of the pharmaceutical drug development process Excellent verbal and written communication skills. Awareness of CDISC SDTM and ADaM standards. Strong organization, analytical and communication skills.