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3.0 - 7.0 years
12 - 16 Lacs
Pune
Work from Office
Description. Principal Stat Programmer. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.. Works to ensure that outputs meet quality standards and project requirements.. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.. Keeps project team members informed of programming progress and issues requiring their attention.. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).. Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately definesall variables to be accepted by peer review and sponsor/requestor with little rework.. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programmingdeliverables.. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards. When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML). When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.. Transfers deliverables.. Performs other work-related duties as assigned.. Minimal travel may be required. Qualifications. Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred.. Experience in mentoring others in clinical trial process and CDISC Standards.. Excellent written and verbal communication skills.. Ability to read, write, speak and understand English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less
Posted 1 month ago
8.0 - 12.0 years
25 - 30 Lacs
Hyderabad
Work from Office
Description Director, Statistical Programming Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Works cooperatively with Statistical Programming and Biostatistics leadership to establish and maintain Standard Operating Procedures (SOPs) and guidelines, promoting standardized and consistent processes to maximize the efficiency of the department, Ensures that the Statistical Programming department meets timelines, provides high quality deliverables, complies with contractual project requirements and SOPs, and conducts projects within budget, Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching, Responsible for staff development of entire reporting hierarchy, training and retention Facilitates succession planning and maintains a Statistical Programming staff with diverse skills, abilities, and competencies meeting the business needs of the department, Makes recommendations for, and participates actively in hiring, onboarding, transferring and terminating staff, Meets with subordinate managers routinely to evaluate and develop solutions for project resourcing, quality, timelines, budget, standard processes, and training needs Keeps senior management informed of decisions and issues which impact the department, Prioritizes activities across Statistical Programming projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges, Directs and coordinates statistical programming activities, and supports the assignment of, or directly assigns programmers to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience, Provides input to forecasting and planning activities for department, Leads departmental or corporate initiatives, Supports business development activities, Performs other work-related duties as assigned, Minimal travel may be required, Qualifications What were looking for Undergraduate degree or equivalent preferred, ideally in Mathematics, Statistics, Computer Science, or related field, Extensive experience in programming in a clinical trial setting with increasing levels of responsibility, or an equivalent combination of education and experience, Previous progressive management experience with demonstrated leadership ability, Proven ability to effectively prioritize projects, recruits and develop staff, and manage resources, Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade, Ability to read, write, speak, and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,
Posted 1 month ago
3.0 - 6.0 years
6 - 11 Lacs
Mumbai, Nagpur, Thane
Work from Office
Description Sr Statistical Programmer SDTM, ADAM & TLFs Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications, Works to ensure that outputs meet quality standards and project requirements, Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings, Keeps project team members informed of programming progress and issues requiring their attention, Follow applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness, Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload, Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines allvariables to be accepted by peer review and sponsor/requestor with little rework, Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others, Conducts effective internal meetings (appropriate in format, frequency and attendance) Distributes relevant information in advance Ensures minutes are promptly and accurately distributed Follows action items through to completion, and maintains order and focus of meetings, working toward consensus, Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business, Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted, Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programming deliverables, Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities, Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor, Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Should have an experience of 5+ years in Clinical Statistical programming with expertise in end-to-end programming (SDTM, ADAM & TLGs), Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, Excellent written and verbal communication skills, Ability to read, write, speak and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,
Posted 1 month ago
3.0 - 7.0 years
10 - 14 Lacs
Mumbai, Nagpur, Thane
Work from Office
Description Sr Stat Programmer (SDTM + ADAMs + TLF) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications, Works to ensure that outputs meet quality standards and project requirements, Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings, Keeps project team members informed of programming progress and issues requiring their attention, Follow applicable SOPs, WIs, and relevant regulatory guidelines (e-g ICH), Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness, Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload, Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately definesall variables to be accepted by peer review and sponsor/requestor with little rework, Conducts effective internal meetings (appropriate in format, frequency and attendance) Distributes relevant information in advance Ensures minutes are promptly and accurately distributed Follows action items through to completion, and maintains order and focus of meetings, working toward consensus, Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business, Accountable for on-time delivery across concurrent programming deliverables Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions, Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programmingdeliverables, Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities, Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor, Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process, Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions, Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures, Contributes technical expertise to the development of programming tools and macros for standardization and efficiency, When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents (i-e DEFINE XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards, Transfers deliverables, Performs other work-related duties as assigned, Minimal travel may be required Qualifications Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience, Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers, Knowledge and experience in the use of CDISC Standards for regulatory agency requirements Experience in submissions to a regulatory agency preferred, Experience in mentoring others in clinical trial process and CDISC Standards, Excellent written and verbal communication skills, Ability to read, write, speak and understand English, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show more Show less
Posted 1 month ago
8.0 - 13.0 years
25 - 30 Lacs
Bengaluru
Work from Office
Job Description About Signify Through bold discovery and cutting-edge innovation, we lead an industry that is vital for the future of our planet: lighting Through our leadership in connected lighting and the Internet of Things, we're breaking new ground in data analytics, AI, and smart solutions for homes, offices, cities, and beyond, At Signify, you can shape tomorrow by building on our incredible 125+ year legacy while working toward even bolder sustainability goals Our culture of continuous learning, creativity, and commitment to diversity and inclusion empowers you to grow your skills and career, Join us, and together, well transform our industry, making a lasting difference for brighter lives and a better world You light the way, More About The Role Were looking for a Data Scientist to work on Deep learning, machine learning, data mining, and statistical modelingfor providing predictive and prescriptive enterprise analytics Successful candidates will be expected to guide a team of Data Scientists, investigate state of the art techniques in advanced machine learning and statistical modeling, and design, develop, and deploy state-of-art, scalable systems for innovative analytics applications across various functional areas (e-g Finance, Sales, Marketing, Supply Chain, etc ) Applicants will be expected to work with a diverse set of data sources, such as time series data, graph data, semi-structured and unstructured data, and build statistical / machine-learning / Deep Learning/Gen AI models in support of on-demand, real-time analytic services The applicant should also have strong skills in explaining the analytic models and outcomes to business stakeholders, Youll be part of the Signifys Enterprise Data & Analytics team, based in Bangalore, More About You Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, or a related field 4+ years of hands-on experience in data science or a related field with demonstrated history of delivering analytics models and solutions Strong programming skills in Python, PySpark or other statistical programming languages Strong foundation in machine learning and deep learning algorithms and expertise in natural language processing (NLP) and computer vision techniques Experience with popular deep learning frameworks such as TensorFlow and PyTorch Research and explore the latest advancements in generative AI, including techniques like natural language processing (NLP), computer vision, and machine learning Develop and implement generative AI models and algorithms to address specific business challenges Train and fine-tune generative AI models using large datasets and industry-specific knowledge to improve accuracy and efficiency Knowledge of cloud platforms like AWS, GCP, or Azure Strong problem-solving skills, communication skills and the ability to think creatively and strategically with a focus on business outco Everything well do for you Opportunity to work on some of the highly complex and challenging business problems across a variety of functional and business domains, Competitive salary depending on experience, Extensive set of tools to drive your career, such as a personalized learning platform, training and coaching You can grow a lasting career here Well encourage you, support you, and challenge you Well help you learn and progress in a way thats right for you, with coaching and mentoring along the way Well listen to you too, because we see and value every one of our 30,000+ people, We believe that a diverse and inclusive workplace fosters creativity, innovation, and a full spectrum of bright ideas With a global workforce representing 99 nationalities, we are dedicated to creating an inclusive environment where every voice is heard and valued, helping us all achieve more together,
Posted 1 month ago
2.0 - 5.0 years
7 - 11 Lacs
Hyderabad
Work from Office
Our Team Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally, Main Responsibilities The Senior Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QCd data packages including tables, figures, and listings for use in publications (i-e abstracts, posters, oral, presentations, manuscripts and ad-hoc data analysis requests) ;The Senior Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Senior Statistical Programmer will ensure SOPs are followed and timelines and quality are met, People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product with an objective to develop statistical data outputs, Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry 2) Design, develop, test, implement, and document statistical programming in high-level software packages e-g SAS 3) Produce well documented data packages that include tables, listings, and figures 4) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables About You Experience: Master's degree minimum 4 years/b-sc minimum 6 years of relevant experience required Soft skills: Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment Technical skills: Advance SAS programming skills, SDTM & ADaM (CDISC) Education: Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field, Languages: Excellent English language knowledge written and spoken Pursue progress, discover extraordinary Better is out there Better medications, better outcomes, better science But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen So, lets be those people, At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity, Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi,! null
Posted 1 month ago
1.0 - 5.0 years
6 - 10 Lacs
Kolkata, Mumbai, New Delhi
Work from Office
About Us: Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more Based in SF and Hyderabad, we are a young, fast-moving team on a mission to build AI for Good, driving innovation and positive societal impact, We are looking for a skilled Statistical Programmer with at least 2 years of experience to write code for the collection, analysis, and presentation of data in various research and business projects, Key Responsibilities: Write and optimize statistical code for data analysis and model development, Implement statistical methods for clinical trials, research, and business insights, Work with large datasets, ensuring the data is accurate, clean, and well-organized, Required Qualifications: 2+ years of experience in statistical programming, Proficiency in statistical programming languages like SAS, R, or Python, Experience in data visualization and reporting using tools such as Tableau or Power BI, Why Join Us Competitive pay (??1200/hour), Flexible hours, Remote opportunity, NOTE: Pay will vary by project and typically is up to Rs 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs 108K per month) once you clear our screening process, Shape the future of AI with Soul AI!
Posted 1 month ago
9.0 - 14.0 years
14 - 19 Lacs
Hyderabad
Work from Office
As a Senior Principal Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing you to lead asset teams and mentor junior staff effectively. In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in statistical programming. Your responsibilities will include leading the trial or asset programming team as the Lead Statistical Programmer, ensuring that asset and trial delivery aligns with established timelines and quality standards. You will perform programming activities at both trial and asset levels, including the development of SDTM and ADaM datasets and the creation of specifications. Additionally, you will develop and validate analytical outputs in accordance with the Statistical Analysis Plan and create datasets for integrated analyses like ISS or ISE. You will also be responsible for executing ad-hoc programming activities based on internal and external requests. Actively contributing to statistical programming initiatives, you will support process improvements and innovation while providing expert advice, guidance, and training to trial and asset teams, fostering the development of your colleagues' skills. Who are you: BSc or MSc (in a numerate discipline preferably in Mathematics, Statistics or Computer Science) Proven success in a Statistical Programming role within clinical development at a pharmaceutical or biotech company, or at a CRO, equivalent to a minimum of 9 years directly relevant experience. Experience in an international environment is a plus. Advanced skills in R and SAS Full familiarity of CDISC SDTM and ADaM standards (including specifications, Define.xml, and reviewers guide) and underlying concepts. Strong understanding of processes related to clinical development programs, Experience in leading e-submission processes is beneficial. Demonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomes Ability to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions.
Posted 1 month ago
7.0 - 12.0 years
5 - 15 Lacs
Hyderabad, Bengaluru, Mumbai (All Areas)
Work from Office
Role & responsibilities Programming: Proficiency in both SAS and R languages, including syntax, data manipulation techniques, and statistical modeling. Data Analysis: Experience with data extraction from various sources, cleaning, preprocessing, and statistical analysis using SAS and R. Statistical Modeling: Ability to apply various statistical models, including linear regression and mixed-effects models, in both SAS and R. Reporting and Visualization: Experience with creating reports (e.g., using Qlik or R Markdown) and visualizations to communicate findings effectively Troubleshooting: Strong analytical and problem-solving skills to troubleshoot and resolve complex issues in SAS and R code. Communication: Ability to communicate technical concepts to non-technical stakeholders effectively. Collaboration: Experience working in a team environment and collaborating with other professionals, such as biostatisticians Under moderate guidance, designs, develops, evaluates and modifies SAS and R programs to analyze and evaluate clinical data. Plans, writes and executes statistical programs in SAS and R designed to analyze data from database. Produces tables, listings and figures. Assesses data accuracy and consistency. Extract data from the SAS system and developed R scripts to clean, preprocess, and analyze data. Application of advanced statistical models, including linear regression and mixed-effects models
Posted 1 month ago
7.0 - 12.0 years
15 - 20 Lacs
Mumbai, Maharashtra, India
On-site
Minimum 2 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate
Posted 1 month ago
7.0 - 12.0 years
15 - 20 Lacs
Nagpur, Maharashtra, India
On-site
Minimum 2 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate
Posted 1 month ago
5.0 - 10.0 years
15 - 20 Lacs
Nagpur, Maharashtra, India
On-site
Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Posted 1 month ago
5.0 - 10.0 years
15 - 20 Lacs
Nagpur, Maharashtra, India
On-site
Programming, specifically J Review, SQL, R and GitHub. Good to have Python. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data base and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Posted 1 month ago
5.0 - 10.0 years
15 - 20 Lacs
Mumbai, Maharashtra, India
On-site
1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Posted 1 month ago
5.0 - 10.0 years
15 - 20 Lacs
Mumbai, Maharashtra, India
On-site
Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Posted 1 month ago
7.0 - 12.0 years
20 - 35 Lacs
Bengaluru
Remote
Job Description 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. 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.
Posted 1 month ago
5.0 - 8.0 years
7 - 10 Lacs
Vijayawada
Work from Office
Location : Vijayawada , Andhra Pradesh Office timings : 1:30 Pm to 10 PM Client details : Channelsoft IT services Pvt Ltd Domain: Health Care (Clinical Trails) About Channelsoft Channel Soft is a pioneer in IT outsourcing and offshore software development business that envisioned and instigated the adoption of the flexible business practices that today enable our client companies to operate more efficiently and produce more value. Currently in India we have employees around 550+ working on various technologies like java,.net , DB, BI, AWS and support team . Office address : Nagarjuna nagar , near NTR university , Vijayawada . Responsibilities For Clinical SAS Programmer: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Creating, validating and executing SAS programs and macros Utilizing SAS programming skills to provide ad-hoc reports (external and internal) and participating in project meetings (internal and external) Assist in developing programming specifications and in creating program specific validation plans Identifying and implementing solutions for complex reporting needs Creating and/or reviewing data editing and export specifications Working directly with clinical data manager and where needed with clinical project manager and other team members to ensure specifications are clear and accurate. Has a clear understanding of the contextual requirements for reporting outputs; and provides feedback Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas Programming and testing data export programs in accordance with specific client needs Documenting all programming and validation efforts in accordance with Good Clinical Practices Monitoring data integrity throughout a given study and utilizing SDTM guidelines to create transfer datasets Participating in the development of data editing conventions, specification documents and Clinical Data Management (CDM) processes Contributing to, designing and maintaining a library of reusable code Leading and managing enhancements to current CDM systems and providing inputs in the implementation of new systems Working independently and efficiently with minimal input required from the manager. Reviewing timelines; and projecting estimates and target dates in conjunction with direct supervisor and project team Adhering to target dates for project timelines and communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of progress as well as potential impediments Adhering to established processes and standards Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Maintain and review clinical programming SOPs and participating in the modification of company SOPs Working with internal staff to resolve issues and exploring new opportunities to add value to organization and departmental processes Helping others to achieve results and performing other duties as assigned Attending and participating in applicable company-sponsored training Education: Bachelors or Masters degree in computer science, life sciences or related field preferred SAS Certified Professional considered a plus What were looking for 3 + years SAS programming experience in pharmaceutical related industry required (1 year with Masters degree) Experience working with CDISC, SQL and Relational Databases preferred Demonstrated programming skills required Working knowledge and solid understanding of database organization and how to extract data in order to generate listings and reports Proven ability in analyzing data and understanding of medical and/or clinical trial terminology is desirable Proven ability in problem solving and ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation , organizational skills and ability to project and maintain a professional and positive attitude
Posted 1 month ago
4.0 - 9.0 years
4 - 9 Lacs
Bengaluru
Remote
Biostatistician cum Statistical Programmer Job Description Performs biostatistical and SAS programming activities for given clinical trials involving Novel, Biosimilar and PMS studies. As a Biostatistician cum Statistical Programmer youll work on a variety of projects, while collaborating with our cross-functional team of experts. You’ll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. You’ll also contribute to research design and analytical strategies, provide input into protocols, Statistical Methodology and develop and review statistical analysis plans. As a Statistical Programmer, you will leverage your SAS programming skills to support Phase I-IV clinical trials. with expertise in CDISC implementation (SDTMs, ADaMs) & TFLs, and experience in Regulatory Submissions as a part of the Statistical Programming, will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions. Responsibilities • Provide SAS programming support to all clinical projects (Phase 1 to 4). Manage programming CROs providing oversight for programming deliverables. Create programming related SOPs, as necessary. Works in tandem with CRO' s Biostatistics and SAS Programming and Data Management teams on various clinical projects. • Provide statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for integrated reports). • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming. Applying your SAS programming skills, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s). Generating complex ad-hoc reports for publications. • Reviews/Develops SAS macros, templates and utilities for data cleaning and reporting. Reviews/ analyses specified in the protocol or the Statistical Analysis Plan (SAP) is implemented while working with the biostatisticians. • Reviews CRF annotations and data specifications & discuss data structures and participate in data review activities. • Provide input into statistical programming solutions and/or ensure their efficient implementation. In consultation with the Biostatistician, responsible for reviewing of programming specifications of analysis datasets and pooled datasets. • Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. • Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance. Performs quality control on final reports. Ensures the accuracy of statistical programming components of scientific reports and/or publications with high quality. • Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives Technical / Functional Skills Knowledge of applied parametric and non-parametric statistics, Mixed Model. Missing Data analysis, General Linear models - ANOVA, ANCOVA, t-test, etc Non-Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression. Strong SAS/R programming Skills in R software. Advanced SAS and other statistical computing software skills in a clinical data environment across multiple therapeutic areas. Good Knowledge of CDISC implementation (SDTMs, ADaMs) Minimum requirements • Master degree in statistics with Ideally 4+years of work experience in a programming role preferably clinical trials/ or in pharmaceutical industry or CROs. • Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.
Posted 1 month ago
1.0 - 6.0 years
4 - 6 Lacs
Bengaluru
Work from Office
Hello Candidate , We are #hiring for Project Associate - I ! Government Project Payroll company: - E Solutions Job role: - Project Associate - I ! Educational Qualifications: Masters degree in Statistics / Biostatistics from recognized University / Institution with one year of experience. No. of Vacancy :- 01 Age Limit: The upper age limit is 40 years
Posted 1 month ago
5.0 - 6.0 years
20 - 25 Lacs
Chennai
Work from Office
An Individual Contributor role Productive h ands on programming, supporting deliverables in the study / project / portfolio / standards team, of medium - high complex statistical programming deliverables to support assets and study teams Performs tasks with limited supervision early in role and independently later in role. Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones Ensures adherence to high quality programming standards in their daily work Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance. Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables. Active self-learning and delivering on solutions in the space of statistical programming and data standards Contribute to SDSA initiatives globally and locally. Work Location Assignment: Flexible Work Location Assignment: Hybrid Medical #LI-PFE
Posted 1 month ago
7.0 - 12.0 years
6 - 10 Lacs
Thane
Work from Office
Provide experienced technical expertise to develop process methodology for department to meet internal and external clients needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Essential Functions Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks. Program and plan the integration of databases from multiple studies or sources. Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies. Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications. Fulfill project responsibilities at the level of statstical team lead for single complex studies or group of studies. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for single studies. May manage project budget and resource requirements, and provide revenue forecasts for single studies. Provide training and guidance to lower level staff. Qualifications Masters Degree Computer science or related field and 7years relevant experience Req OrBachelors Degree Computer science or related field and 8 years relevant experience ReqEquivalent combination of education, training and experience in lieu of degree Req Knowledge of statistics, programming and/or clinical drug development process Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language Good organizational, interpersonal, leadership and communication skills Ability to effectively manage multiple tasks and projects Excellent accuracy and attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients
Posted 1 month ago
6.0 - 10.0 years
7 - 10 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
Leads Implementation of statistical programming aspects of the protocol or clinical development program Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contributes to cross-functional administrative or process improvement initiative(s) Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function Drives standards development and implementation Manages and escalates risk in complicated or novel situations within their study and/or projects Provides Programming expertise to the team Provides tactical input and/or drives ideas and improvements Contributes to the function by supporting recruiting and/or providing training and mentorship Finds opportunities to improve methodology and provides practical solutions for problems Manages activities of our external partners (i.e., Contract Research Organisations) Influences collaborators by providing subject matter expertise on programming-related items Ensures compliance with standards and automation usage Employs all project management practices in managing drug or technical projects Provides input to capacity management for all projects in scope Maintains expertise in the latest industry and regulatory requirements to stay current Essential Skills/Experience Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science or equivalent Proven programming expertise Thorough knowledge of the clinical development process Thorough knowledge of industry standards and ability to implement them Ability to apply programming expertise to problem-solving and troubleshooting for teams Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items Ability to manage risk in complicated or novel situations Project Mindset
Posted 1 month ago
1.0 - 4.0 years
4 - 8 Lacs
Hyderabad
Work from Office
The Associate Statistical Programmer will work with Medical Affairs biostatisticians and/or programmers and Sanofi Business Operations biostatistics and programming personnel to implement statistical analysis plans and provide QC d data packages including tables, figures, and listings for use in publications (ie abstracts, posters, oral, presentations, manuscripts, and ad-hoc data analysis requests) ; The Associate Statistical Programmer will assist in developing, implementing of programming techniques. The Associate Statistical Programmer will ensure SOPs are followe'd and that timelines and quality standards are met. People: 1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and/or programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs. Performance / Process: 1) Conduct appropriate post-hoc statistical analyses of clinical trial data and/or registry. 2) Design, develop, test, implement, and document statistical programming in high-level software packages eg SAS. 3) Produce we'll documented data packages that include tables, listings, and figures. 4) Closely follow QC plans and timelines set by senior members of the Sanofi Business Operations biostatistics and programming team. 5) Remain current on advanced programming methods Customer: 1) Work closely with Global Medical Affairs biostatisticians and/or programmers to identify statistical analysis needs and assist in developing assigned deliverables. About you Experience : B.Sc. or Masters degree minimum 1 years of relevant experience required, or a minimum of 6 months of relevant internship experience. Soft skills : Ability to manage timelines and Ability to work independently and within a team environment. Technical skills : Base SAS programming skills, basic knowledge SDTM & ADaM (CDISC) Education : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field. Languages : Excellent English language knowledge - written and spoken
Posted 1 month ago
7.0 - 11.0 years
2 - 6 Lacs
Mumbai
Work from Office
Skill required: Data Scientist - Data Science Designation: Specialist Qualifications: Any Graduation Years of Experience: 7 - 11 Years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Insights & Intelligence vertical and help us generate insights by leveraging the latest Artificial Intelligence (AI) and Analytics techniques to deliver value to our clients. You will also help us apply your expertise in building world-class solutions, conquering business problems, addressing technical challenges using AI Platforms and technologies. You will be required to utilize the existing frameworks, standards, patterns to create architectural foundation and services necessary for AI applications that scale from multi-user to enterprise-class and demonstrate yourself as an expert by actively blogging, publishing research papers, and creating awareness in this emerging area. You will be working as a part of Marketing & Customer Analytics team which provides a set of processes that measure, manage and analyze marketing activities in order to provide actionable insights and recommendations to marketing organizations in terms of optimizing ROI & performance efficiency in operations.Customer analytics is a process by which data from customer behavior is used to help make key business decisions via market segmentation and predictive analytics. This information is used by businesses for direct marketing, site selection, and customer relationship management. You should have exposure to digital marketing, A/B testing, MVT, Google Analytics/Site Catalyst. You will be a core member of Accenture Operations global Applied Intelligence group, an energetic, strategic, high-visibility and high-impact team, to innovate and transform the Accenture Operations business using machine learning, advanced analytics to support data-driven decisioning. The objectives of the team include but are not limited toLeading team of data scientists to build and deploy data science models to uncover deeper insights, predict future outcomes, and optimize business processes for clients. Refining and improving data science models based on feedback, new data, and evolving business needs. Analyze available data to identify opportunities for enhancing brand equity, improving retail margins, achieving profitable growth, and expanding market share for clients. What are we looking for Extensive experience in leading Data Science and Advanced Analytics delivery teams Strong statistical programming experience - Python, R, SAS, S-plus, MATLAB, STATA or SPSS. Experience working with large data sets and big data tools like Snowflake, AWS, Spark, etc. Solid knowledge in at least one of the following Supervised and Unsupervised Learning, Classification, Regression, Clustering, Neural Networks, Ensemble Modelling (random forest, boosted tree, etc.), Multivariate Statistics, Non-parametric Methods, Reliability Models, Markov Models, Stochastic models, Bayesian Models Experience in atleast one of these business domainsCPG, Retail, Marketing Analytics, Customer Analytics, Digital Marketing, eCommerce, Health, Supply Chain Extensive experience in client engagement and business development Ability to work in a global collaborative team environment Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally, interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification Any Graduation
Posted 1 month ago
10.0 - 15.0 years
7 - 12 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
- Serve as the Lead Programmer and Manager of the statistical programming efforts. - Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. - Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. - Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. - Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. - Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. - Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. - Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. - Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. - Act as the primary department contact to ensure that department standards are implemented in all studies. - Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. - Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience - 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. - 4+ years project management experience in the CRO or Pharmaceutical Industry. - Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. - Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. - Strong verbal and written communication skills - ability to clearly and effectively present information. - An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. - Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. - Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. - Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. - Advanced experience with: - Constructing technical programming specifications. - Relational Databases. - Good Clinical Practices. - Good Programming Practices. - 21CFR Part 11 Standards. - Integrated Summary Safety/Efficacy Analyses. - Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience - BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. - Competencies: - Accountability - Collaboration - Decision Quality - Drive for Results - Perseverance - Problem Solving - Informing - Peer Relationships - Time Management - Building Effective Teams - Managing Through Systems
Posted 1 month ago
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