75 Adam Jobs

Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in FSP.

6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis

:. 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. . 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. NOTEPay 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. . Shape the future of AI with Soul AI!.

:. 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. . 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. NOTEPay 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. . Shape the future of AI with Soul AI!.

:. 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. . 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. NOTEPay 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. . Shape the future of AI with Soul AI!.

:. 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. . 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. NOTEPay 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. . Shape the future of AI with Soul AI!.

Job Job TitleKey Account Executive - E-Commerce Company NameTitan Job TypeRegular/ Job CategoryOther DepartmentE-Commerce LocationBengaluru, Karnataka, India Titan, a leading retail company in India, is seeking a highly motivated and experienced Key Account Executive to join our E-Commerce team in Bengaluru. As a Key Account Executive, you will be responsible for managing and growing our key accounts in the E-Commerce sector. Growth Primary/ Retail Sales 1) Meeting the monthly primary/ retail sales target of designated platforms. 2) Ensuring growth in sales Value YoY by planning necessary marketing activities and understanding the category trend. 3) Preparing the monthly Inventory range plan in association with merchandiser based on ROS & New Product launch 4) Timely Co-ordination with Supply chain, CFAs and Platforms for entire order fulfilment lifecycle. 5) 95%+ of range plan is live at any time. Value Creation Debtors, Payouts & Compliance 1. No over dues for the review period -Sending Reminders to partner on overdue/outstanding. Collecting sales data for credit note working. 2. All payouts should be in the budgeted limits 3. Timely Communication to internal stakeholder & associates Customer/ Stakeholder Satisfaction Partner Management 1) Healthy working relationship with internal and external stakeholders 2) Periodic business review meet with all partners (Internal & External) 3) Listing of the new products with correct information on the platforms 4) Resolving partners disputes in coordination with internal stake holders. 5) Uploading the schemes/ discounts as per the planned schemes. Innovation New Process and Initiative 100% listing of active line on the platforms Continuous replenishment for Top Sellers for partner with a Fill rate of at least 75% 10% contribution of NP on a overall target. Work Experience Education QualificationsGraduation ExperienceMinimum 1 year experience in a consumer goods company (Fashion, Electronics, FMCG) or retailers ( Flipkart/ Myntra/Amazon/ Shoppers Stop/ Lifestyle/ DMart ) \u2013 working in a sales / operations role Skills: MS Excel and data management Written & Spoken skills stake holder management Communication skills.

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs 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 Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.sdtm programmerProgram mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for sdtm programmersdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation,BE,BTech

Job Overview Provide advanced technical expertise to develop and maintain programs to meet internal and external clients needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. Essential Functions • Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing summaries, (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 the integration of databases from multiple studies or sources. • Develop programming documentation including plans and specifications, as appropriate. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department. • Perform and plan the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of statistical team lead for single studies, under supervision. • Understand the Scope of Work, estimate the work completed, and manage Out of Scope for single studies. May manage budget and resource requirements and provide revenue and resource forecasts for single studies. May be required to understand budget and quote assumptions. • Provide training and guidance to lower level and new staff. Qualifications • Master's Degree Computer science or related field and 1 year relevant experience Req Or • Bachelor's Degree Computer science or related field and 2 years relevant experience Req • Equivalent combination of education, training and experience Req • Knowledge of statistics, programming and/or clinical drug development process • Working knowledge of computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership and communication skills • Ability to effectively handle multiple tasks and projects • Excellent accuracy and attention to detail • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Essential Functions: • Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically. • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies. • Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines. • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables. • Use and promote the use of established standards, SOP and best practices. • Provide training and mentoring to SP team members and Statistical Programming department staff. Qualifications: • Bachelor's Degree Maths, Computer science, Statistics or related field and 10 years relevant experience Req Or • Master's Degree Maths, Computer science, Statistics or related field and 12 years relevant experience Pref • Typically requires 7+ years of prior relevant experience • Equivalent combination of education, training and experience in lieu of degree • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience. • Advanced 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, where applicable • Excellent organizational, interpersonal, leadership and communication skills • Excellent accuracy and attention to detail • Aptitude for mathematical calculations and problem solving • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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

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,

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

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.

Role & responsibilities 1) Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials 2) Experience creating and working with Utility Macros 3) Experience creating specification 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs 12) Experience in Ephicacy and safety tables. We have opening for other roles to.... SAS Macros, Bio statics Interested candidates can share thier resumes at - shubhanshi.agarwal@mounttalent.com Whatsapp - 7302239534

SAS MACROS Pan India One of the leading Lifescience company in India mail at manjeet.kaur@mounttalent.com Whatsapp at 8384077438 Experience Required : 7 to 10 Years of experience 1)Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs 2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents. 3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP) 4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members. 5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required 6) Develop, Debug Utility macros for reusability and efficiency Skill Set - 1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials. 2) Experience creating and working with Utility Macros 3) Experience creating specifications 4) Experience with CDSIC standards including CDASH or SDTM/ADaM 5) Ability to work independently and as part of a team 6) Being open to new learnings and sharing with team members 7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills] 8) Proficient in using SAS EG/Studio for programming 9) Familiar with Unix environment and programming 10) Prior working experience in Vaccines or Oncology is an added advantage 11) Familiarity with multiple statistical procedures and functions to create TFLs

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

Novo Nordisk Global Business Services ( GBS) India Department - Global Data & Artificial lntelligence Are you passionate about building scalable data pipelines and optimising data workflowsDo you want to work at the forefront of data engineering, collaborating with cross-functional teams to drive innovationIf so, we are looking for a talented Data Engineer to join our Global Data & AI team at Novo Nordisk. Read on and apply today for a life-changing career! The Position As a Senior Data Engineer, you will play a key role in designing, developing, and main-taining data pipelines and integration solutions to support analytics, Artificial Intelligence workflows, and business intelligence. It includes: Design, implement, and maintain scalable data pipelines and integration solutions aligned with the overall data architecture and strategy. Implement data transformation workflows using modern ETL/ELT approaches while establishing best practices for data engineering, including testing methodologies and documentation. Optimize data workflows by harmonizing and securely transferring data across systems, while collaborating with stakeholders to deliver high-performance solutions for analytics and Artificial Intelligence. Monitoring and maintaining data systems to ensure their reliability. Support data governance by ensuring data quality and consistency, while contributing to architectural decisions shaping the data platform's future. Mentoring junior engineers and fostering a culture of engineering excellence. Qualifications Bachelor’s or master’s degree in computer science, Software Development, Engineering. Possess over 10 years of overall professional experience, including more than 4 years of specialized expertise in data engineering. Experience in developing production-grade data pipelines using Python, Data-bricks and Azure cloud, with a strong foundation in software engineering principles. Experience in the clinical data domain, with knowledge of standards such as CDISC SDTM and ADaM (Good to have). Experience working in a regulated industry (Good to have). About the department You will be part of the Global Data & AI team. Our department is globally distributed and has for mission to harness the power of Data and Artificial Intelligence, integrating it seamlessly into the fabric of Novo Nordisk's operations. We serve as the vital link, weaving together the realms of Data and Artificial Intelligence throughout the whole organi-zation, empowering Novo Nordisk to realize its strategic ambitions through our pivotal initiatives. The atmosphere is fast-paced and dynamic, with a strong focus on collaboration and innovation. We work closely with various business domains to create actionable insights and drive commercial excellence.

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides Provide technical leadership and mentorship to global programming teams Collaborate closely with biostatistics, data management, and regulatory affairs teams Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards Required Qualifications: Bachelors or Masters degree in Statistics, Computer Science, or a related field 10+ years of SAS programming experience in clinical research or pharmaceutical industry Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis Deep understanding of CDISC standards, regulatory compliance, and submission requirements Prior experience in oncology, neuroscience, or immunology domains preferred Proven leadership capabilities in managing cross-functional and global teams Excellent communication, project management, and problem-solving skills Preferred Tools & Skills: SAS (Base, Macro, STAT, Graph) Familiarity with SDTM/ADaM IG, FDA submission standards Understanding of regulatory submission formats (eCTD) How to Apply / Schedule an Interview: Send your details via WhatsApp or Call : Puja- (8250242229) in the following format: Full Name: Mobile Number: Email Address: Highest Qualification: Total Experience: Current Organization: Preferred Location: Current CTC: Expected CTC: Notice Period: Note: If the line is busy, please drop a WhatsApp message and we will get back to you at the earliest. Referrals Welcome! Know someone who fits the bill? Share this post and help them grow their career! You & I Consulting Your Career Growth Partner

Salary : 2.2LPA - 14k Change in Hand per month (after deductions of PF,ESI,PT) 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Must have a SAS training Certificate. Role & responsibilities: 1. Providing inputs related to statistical methods for various study design ( two way, parallel, replicate, study state etc) and protocol preparation considering the requirements of BE studies for USFDA, EMEA, CANADA etc submission. 2. Preparation of randomization schedule as per the protocols and applicable SOPs for following study designs ( two way, parallel, replicate, study state etc). 3. Data checking for consistency and outlier analysis for bio-analytical data as well as PK data. 4. Perform statistical analysis of PK data using SAS software for different study designs ( two way, parallel, replicate, study state etc) for USFDA, EMEA, CANADA etc submission. 5. Preparation of statistical report and SAP. 6. Provide sample size estimation/ justification. 7. Statistical outlier detection as per the concerned protocol or regulatory requirements. 8. Response preparation for addressing the regulatory queries related to statistical aspects.

Job Description : As a biotechnology trailblazer, we're dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and well rewrite the future of healthcare together. Job purpose : The Statistical Programmer will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs. Duties and responsibilities : SAS Programming : You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy). CDISC Standards : Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs). Study Lead: Experience juggling multiple projects simultaneously is preferred. Submission Documents : You'll create and review submission documents and electronic case report forms (eCRTs). Collaboration: Effective communication with cross-functional teams and clients is crucial. Assists the Senior Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review. Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays. Provides tabular and written summaries of analyses and statistical methodology. Ensures accurate programming of SAS clinical data extracts and data displays. Develops programming specifications, including analysis datasets and tables/listings/figures. Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements. Ensures the integration of data across studies in support of CSS/CSE. Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies. Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents). Interfaces with CRO to ensure data and statistical reporting is secure and timely. Proactively identifies risks, developing and implementing mitigation plans as applicable. Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs. May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports. If applicable, develops and provides department training for applications and standard tools developed by the department functions group. Qualifications : MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry. Expertise: Familiarity with statistical principles, CDISC data, and standards. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus SAS, (Base, Stat, Macro, graph); SAS certificates a plus Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. This is a largely sedentary role.

Roles And Responsibilities: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate.

ROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy •Develop and/or validate Tables, Listings, and Figures using SAP and mock shells •Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards •Ability to work independently and as part of a team environment •Provide the status of assigned tasks to the Study Lead Programmer •Actively participating in the study meetings and support as backup lead •Identify, communicate, and manage study-based risks and issues within the timeframe •Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance •Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines •Provide guidance, mentoring, and training for junior team members as appropriate

PRINCIPAL STATISTICAL PROGRAMMER (12 15 YEARS) LOCATION: ANYWHERE IN INDIA WORK MODE : HYBRID ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion

Roles And Responsibilities: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion.