7 Biostatistician Jobs

The ideal candidate should possess a minimum of 10 years of total experience in the role of a biostatistician on clinical studies with an M.Sc. or a higher degree in Statistics, Biostatistics, Mathematical Statistics, or Applied Statistics. You will be responsible for independently interacting with clients and addressing any queries from them. It is essential to have a thorough knowledge of the pharmaceutical industry, including an understanding of the clinical drug development process, associated documents, and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9, and other regulatory guidance documents is required. Familiarity with statistical programming languages such as SAS and R will be considered an added advantage. Adherence to SOPs and GPP is crucial, ensuring team compliance with organizational policies and procedures while maintaining quality and adhering to timelines. As an Expert Biostatistician, you will be working in the Pharmaceutical industry, specifically in the ITES/BPO/KPO sector. This is a full-time, permanent position falling under the category of Life Sciences and Pharma. Key skills required for this role include expertise in Biostatistics and experience in clinical trials. Job Code: GO/JC/21471/2025 Recruiter Name: Sangeetha,

The ideal candidate for the position should have a minimum of 10 years of experience as a biostatistician in clinical studies, holding an M.Sc. or a higher degree in Statistics, Biostatistics, Mathematical Statistics, or Applied Statistics. You should be able to independently engage with clients and effectively address any queries they may have. It is imperative to possess a thorough understanding of the pharmaceutical industry, including knowledge of the clinical drug development process, associated documents, and relevant regulations. Proficiency in Good Clinical Practice (GCP), Good Programming Practices, ICH-E3, ICH-E9, and other regulatory guidance documents is essential. Familiarity with statistical programming languages such as SAS and R would be an added advantage. Compliance with Standard Operating Procedures (SOPs) and Good Pharmacovigilance Practices (GPP) is crucial, along with ensuring team adherence to organizational policies and procedures while maintaining high quality standards and meeting project timelines. The role requires expertise in biostatistics and a senior managerial position within the ITES/BPO/KPO industry, specifically in the pharmaceutical sector. This is a full-time, permanent position falling under the category of Life Sciences and Pharma. Key skills for this role include biostatistics and clinical trials. Job Code: GO/JC/20522/2024 Recruiter Name: HariharanA,

Job Posting Title: Senior Principal Biostatistician Reports to (Job Title) : - Group Head Biostatistics and Pharmacometrics Job Description : The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. Study level : - Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level -May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level - Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External leve l- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Education (desirable) : - MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 4+ years relevant work experience. Languages : - Fluent English (oral and written) Requirement : - Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives. Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

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.