316 Biostatistics Jobs

Title of project-: Regional Resource Hub at NIRRH for Health Technology Assessment in India funded by Department of Health Research, Ministry of Health and Family Welfare, Government of India. Name of the Post-: Senior Health Economist (Medical / Non-Medical) No. of vacancy -: One Consolidated Salary -: Rs.1,56,100/- (Rs.1,23,000/- plus 27% HRA) Essential Qualification -: MD/ MS / DNB or Ph.D. in any of the subjects like Biochemistry, Health Economics, Public Health, Biosciences, Microbiology, Pharmacology, Biotechnology and Biostatistics AND/OR Equivalent Degree with 3 to 6 Years Experience after MD / MS / Ph.D. in Health Economics or Systematic Review. Desirable / Job Description -: 8-12 years in R&D and academic Institutions / Scientific Organizations in the relevant subject including 3 years in a managerial position with experience in Economic Evaluation with atleast 10 Publications on Health Economics related studies. Age Limit -: 52 Years Duration -: One Year (further continuation based on performance) Place of Posting -: ICMR-NIRRCH, J.M. Street, Parel, Mumbai 400012, Maharashtra. Interested candidate share your updated CV on this Mail ID :- anushka.y@esolglobal.com

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*).The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Chennai Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 5 years of relevant work experience asa Clinical Data Manager. Minimum 5 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office-based* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices . "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location). In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites) Plan and project the resources required including management of tasks, timelines, risk and quality Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks Create training materials for EDC users and provide project-specific training as required Review and validate clinical data to ensure consistency, accuracy, integrity and completeness Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA) Manage the database maintenance, lock and close-out processes and procedure Participate in conference calls and/or meetings with vendors and sponsors Recognize and solve potential problems and evaluate effectiveness Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned Help to align data management and clinical programming best practices, standards and conventions within the company Propose and support initiatives for improving efficiency. Requirements To be successful you will possess: Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification 6+ years' experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications. Good communication skills written and verbal. Effective working knowledge of Microsoft Office Suite including Word and Excel. Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills. Demonstrated flexibility and ability to work well in a fast-paced growing organization. Demonstrated ability to work in a global team environment. Demonstrates a basic understanding of Clinical Trials and the flow of data. Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs. Comprehension of study documentation standards including Trial Master File organization and archival processes. Familiarization of data standards, preferably CDISC STDM. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*).The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings. **This position is for the Bengaluru Location and not home-based** In this role your key tasks will include: Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites). Plan and project the resources required including management of tasks, timelines, risk and quality. Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements. Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements. Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed. Create training materials for EDC users and provide project-specific training as required. Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock). Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data. Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance. Organize and lead Quality Review activities during study. Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA). Manage the database maintenance, lock and close-out processes and procedure. Participate in conference calls and/or meetings with vendors and sponsors. Recognize and solve potential problems and evaluate effectiveness. Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned. Help to align data management and clinical programming best practices, standards and conventions within the company. Provide leadership, expertise and support to other department members. Propose and support initiatives for improving efficiency. Actively support to staff learning & development within the company. Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions . Represent the company at professional meetings, webinars or seminars. Train and mentor data management staff, support in development of new training material and provide training to relevant staff. Participate in the interview process for new recruits. Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System. Assure good communication and relationships with (future) clients. Contribute to and take part in client evaluations and visits. Support in preparation of new proposals and budgets for Data Management services. Requirements To be successful you should possess: Life science, healthcare degree and/or combination of education and experience. Minimum 5 years of relevant work experience asa Clinical Data Manager. Minimum 5 years of experience in drug development and/or clinical research. Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements. Good understanding of Medical Terminology. Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA. Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock). Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation. Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models. Experience in developing data management standards. Strong written and verbal communication skills including a good command of the English language. Representative, outgoing and client-focused. Ability to work in a fast-paced challenging environment of a growing company. Proficiency with various computer applications such as Word, Excel, and PowerPoint required. Administrative excellence. Attention to detail, strong technical, analytical and problem-solving skills. Strong project management skills. Ability to translate guidelines, rules and regulations in clear and usable recommendations. Ability to simplify complex issues into understandable concepts. Excellent organizational, negotiating and motivational skills. Benefits Benefits of working at Allucent include: Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers: *Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Biostatistics Job Category Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical – Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment.

Job Description Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. Qualifications For Essential Functions Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.1. Applies scientific methods to analyse and solve software engineering problems.2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

Company Name: Clinvigilant Research Pvt. Ltd. (A company of GSC Group) . Job Title: Clinical Data Manager Job Location: Ahmedabad- Onsite No. of Position :01 Experience : 03 to 06 Years. A Clinical Data Manager (CDM) plays a key role in managing and overseeing the data collected during clinical trials, ensuring its accuracy, integrity, and compliance with regulations. Here's a typical Job Description (JD) for a Clinical Data Manager Job Summary: The Clinical Data Manager oversees the collection, management, and quality control of clinical trial data. They will work closely with clinical research teams, statisticians, and regulatory authorities to ensure that data is accurately recorded, processed, and analyzed for clinical trials. The role involves ensuring that data is compliant with Good Clinical Practice (GCP) guidelines and relevant regulatory standards. Key Responsibilities: Data Management Plan (DMP): Develop, implement, and maintain the Data Management Plan for clinical trials. Ensure that the DMP aligns with study protocols, regulatory requirements, and internal standards. Database Design & Development: Collaborate with clinical and statistical teams to design and build electronic data capture (EDC) systems and clinical databases. Perform user acceptance testing (UAT) to ensure that the systems are functioning properly. Data Collection & Verification: Oversee the collection and validation of clinical trial data, ensuring all data is accurate and complete. Ensure data consistency by reviewing the case report forms (CRFs) for completeness, accuracy, and compliance. Data Cleaning & Quality Control: Implement and manage data cleaning processes, including discrepancy management, query resolution, and follow-up on data errors. Coordinate with clinical sites and vendors to resolve data issues and discrepancies promptly. Reporting & Documentation: Prepare and maintain comprehensive documentation related to data management processes and outcomes. Ensure all clinical trial data is properly archived for future reference and regulatory compliance. Regulatory Compliance: Ensure compliance with GCP, ICH guidelines, FDA regulations, and other applicable regulatory bodies. Support regulatory submissions by providing high-quality data sets and related documentation. Collaboration & Communication: Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and IT departments. Serve as the primary point of contact for data-related queries and provide data insights to stakeholders. Training & Mentoring: Train clinical data staff and ensure they are informed of current processes, systems, and regulatory requirements. Provide ongoing guidance and mentorship to junior data management staff. Vendor Management: Manage and coordinate relationships with third-party vendors, including EDC providers, CROs, and other partners. Ensure that external vendors adhere to the agreed-upon timelines and data quality standards. Required Qualifications: Education: Bachelor’s degree in Life Sciences, Computer Science, Statistics, or related field. A Master's degree or professional certifications (such as CDISC, GCP, or Clinical Data Management certifications) are advantageous. Experience: 3-5 years of experience in clinical data management or related field, with a strong understanding of clinical trial processes and data handling. Skills: Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle, or similar platforms). Strong understanding of clinical data management concepts, regulatory requirements, and industry standards. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills for effective cross-functional collaboration. Ability to work under pressure and meet tight deadlines. Preferred Qualifications: Experience working with complex clinical trials (multi-site, multi-region). Knowledge of regulatory submissions and reporting (e.g., FDA, EMA). Familiarity with statistical programming and data analysis tools (e.g., SASR). Job Types: Full-time, Permanent Pay: ₹30,000.00 - ₹50,000.00 per month Schedule: Monday to Friday Ability to commute/relocate: Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required) Application Question(s): how you rate yourself in english proficiency( beginner/ average/ professional)? Education: Bachelor's (Required) Experience: CDM: 3 years (Required) Location: Ahmedabad, Gujarat (Required) Expected Start Date: 03/01/2022

Sponsor-dedicated JOB DESCRIPTION Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. Responsibilities As a Principal Statistical Programmer, your responsibilities will include: Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros Participate in the development of CRFs, edit check specifications, and data validation plans Provide review and/or author data transfer specifications for external vendor data Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices Qualifications Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities Must be able to work independently Outstanding communication skills (written and verbal) and strong leadership skills Preferred Qualifications (nice To Have) Prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

Description Sr Medical Writer (CSR, IB, Protocol) 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 Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information 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. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus Leading the clear and accurate completion of medical writing deliverables Managing medical writing activities associated with individual studies Coordinating these activities within and across departments Completing a variety of documents, adhering to established regulatory standards Coordinating quality and editorial reviews Acting as peer reviewers for the internal team Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs Performing online clinical literature searches and complying with copyright requirements Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentoring and leading less experienced medical writers on complex projects Developing deep expertise on key topics in the industry and regulatory requirements Working within budget specifications for assigned projects

You will be responsible for providing statistical input to the design, analysis, reporting, and interpretation of clinical studies, as well as contributing to publications. Utilize SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. Ensure that all outputs meet quality standards and project requirements. Perform validation programming and collaborate with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. Keep the project team informed of programming progress and any issues requiring their attention. Adhere to applicable SOPs and relevant regulatory guidelines. Manage scheduling and time constraints across multiple projects simultaneously. Set goals based on management priorities and adapt to timeline or priority changes by reorganizing daily workload. Prepare in advance for internal meetings, contribute ideas, and show respect for the opinions of others. Demonstrate willingness to collaborate with team members, assist with projects, and support initiatives as necessary to meet business needs. Negotiate and establish accurate time estimates for completing study activities with internal team members and statistical management. Ensure completion of project activities within the allotted timeframe. Assist in drafting regulatory submissions and stay updated with current literature and research new methodologies. Identify, develop, and implement novel statistical methodologies to support medicine development. Uphold scientific integrity and animal welfare in all activities. Interact with global statisticians and implement their recommendations locally. Create and maintain standard macros and applications to enhance department efficiency. Actively participate in process/quality improvement initiatives, standardization efforts, and other non-clinical activities. Contribute to mentoring other team members, develop training courses, present training materials, provide feedback, and guide new associates in the process. Engage in knowledge-sharing activities to foster a collaborative work environment.,

The Biostatistician is responsible for the statistical analysis and interpretation of clinical trial data, working closely with cross-functional teams to ensure accurate and meaningful results. This role involves developing Statistical Analysis Plans (SAPs)and contributing to the randomization process. They will provide expert consultation on statistical methodologies and collaborate with the Statistical Programming team to ensure the integrity of data analyses and outputs. Responsibilities Provide statistical expertise in the design and analysis of clinical trials. Develop and author SAPs for assigned projects. Review clinical trial protocols to ensure statistical soundness and provide feedback to study teams. Author the protocol statistical sections and generate SAPs and study randomization. Analyze clinical trial data using advanced statistical techniques and software. Collaborate closely with Statistical Programmers to review and validate data sets, tables, listings, and other statistical outputs. Review and sign-off on relevant study documents and data management and programming deliverables. Provide programming support to supplemental or exploratory analyses any other internal and external ad-hoc requests. Stay current with relevant regulatory guidelines and ensure compliance in all statistical deliverables. Represent the biostatistics function on project teams and in cross-functional meetings. Perform other duties as required and assigned. Accountabilities Demonstrate efficient and accurate completion of all responsibilities. Support overall delivery strategy and OKRs as directed by management. Education Qualifications: Master’s or PhD in Statistics, Biostatistics, or a related field is required. Bachelor’s degree with substantial working experience in biostatistics will be considered. Experience 2+ years of biostatistics experience, preferably in clinical trials. Proficiency in statistical software such as SAS, R, or Python required. Experience in the life sciences, regulatory environments, and knowledge of 21 CFR Part 11 and GxP is highly preferred. Skills Strong statistical knowledge, including experience with survival analysis, mixed models, and longitudinal data analysis. Excellent problem-solving abilities and attention to detail. Demonstrated ability to work independently and within cross-functional teams. Strong written and verbal communication skills, with the ability to clearly present statistical findings. Familiarity with regulatory requirements for clinical trial data. ₹10,00,000 - ₹20,00,000 a year

Role & responsibilitie About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose (1-2 Lines): To perform Biostatistical activities in Biometrics Department for Clinical Studies Phase 1-4 Key Responsibilities: (Maximum 5-8 Points) Reviewing protocol SAP & RAP preparation and implementation Sample size calculation Provides statistical consultations Preparing and reviewing randomization list Preparing and reviewing of tables, listing and graphs, as applicable Preparing and reviewing of statistical report, as applicable Provides support for blinding and unblinding documentations Preparing and reviewing standard operating procedures Training/Guiding/Mentoring associate biostatisticians and junior programmers. Objectives setting and appraisal for the team Facing client to answer statistical queries Any other responsibilities assigned by the organization from time to time Educational Qualification: M.Sc. in Statistics, Ph.D. in Statistics or any equivalent degree in Statistics Technical/functional Skills: (Maximum 4-6 Points) Expert in any programming language (preferably R and SAS) Clinical Trials Exposure – Pharmacokinetics and Phase I-IV Experience: 10-15 Years Behavioral Skills: Proficient in English (reading and writing), Stress Management, Empathy, Conflict resolution and Patience Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. s Preferred candidate profile

Desired Experience Experience of biostatistics in regulated markets Interacted with regulatory agencies (FDA/EMA/PMDA) Experience of biosimilar product development Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis Knowledge of using relevant software including PASS, SAS, SPSS, R Job Description Prepare scientifically sound statistical design for clinical trials Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA) Perform meta-analysis and calculate sample size Prepare statistical justifications for agency interactions (FDA/EMA/PMDA) Review and provide inputs to statistical sections of clinical trial protocol Plan and perform blinded sample size re-estimation and interim analysis Review and provide inputs to statistical analysis plan and CRF Review tables, listings, figures and clinical study reports Collaborate with internal and external stakeholders (CROs) to resolve issues around statistics Respond to agency queries on issues related to biostatistics Qualification : MSc., PhD in Biostatistics Experience : 10-15 years' experience in a Pharma / CRO

🚨 Job Opening: HEOR / RWE Lead – Senior Scientist / Manager | 5+ Years Experience | Remote/Hybrid Company: KrtrimaIQ Cognitive Solutions Location: Remote / Hybrid (Preferred: Bangalore-based candidates) Experience: 5+ Years Domain: Health Economics & Outcomes Research (HEOR), Real World Evidence (RWE), Life Sciences Analytics 🔍 About the Role KrtrimaIQ Cognitive Solutions is looking for a highly skilled and experienced HEOR / RWE Lead – Senior Scientist / Manager to join our growing team. This role is ideal for someone with a strong background in real-world data analytics, particularly using licensed US claims datasets, and prior experience in a HEOR/RWE vendor environment. You will lead the execution of high-impact projects for global pharmaceutical and life sciences clients, leveraging advanced statistical and epidemiological methodologies to generate actionable insights from real-world evidence. 🧠 Key Responsibilities Data Management: Clean, transform, and prepare analytical datasets using licensed US claims data (e.g., Optum, MarketScan, IQVIA). Advanced Analysis: Conduct robust statistical and epidemiological analyses to derive insights aligned with client objectives. Client-Facing Delivery: Present findings clearly, communicate insights, and support client discussions with high-quality deliverables. Project Leadership: Understand analytical goals, guide junior team members, and manage project timelines and expectations. Cross-Team Collaboration: Work closely with data scientists, statisticians, and domain experts to ensure outcome-focused project execution. ✅ Required Skills & Qualifications Master’s or Ph.D. in Biostatistics, Epidemiology, Health Economics, Data Science, Statistics, or a related quantitative field Minimum 5+ years of experience in a HEOR/RWE vendor environment Hands-on experience working with licensed US claims datasets (e.g., Optum, MarketScan, Truven, IQVIA) Proficiency in SAS, R, Python , or SQL for data analysis Strong understanding of epidemiologic and health economic methodologies Excellent verbal and written communication skills 🌟 Preferred Skills Experience managing or leading HEOR/RWE project teams Exposure to data visualization tools (e.g., Power BI, Tableau) Knowledge of machine learning , GenAI , or automation frameworks applied to healthcare analytics 💼 Why Join KrtrimaIQ Cognitive Solutions? Be part of a disruptive AI & data-driven company in the healthcare domain Work with cutting-edge real-world data technologies and global pharma leaders Collaborative, innovative, and growth-driven work culture Flexible hybrid/remote work model with competitive compensation 📩 Apply now by sending your resume to: nikhil.kumar@krtrimaiq.ai

As a Biostatistician at CPVIA, a clinical data analytics solutions company based in Hyderabad, you will play a crucial role in providing statistical programming outsource and statistical consulting services to pharmaceutical, biotechnology, and medical device companies. Your primary responsibility will be to offer internal statistical support by collaborating closely with lab scientists, technicians, and other statisticians/programmers within the team. Your expertise will be instrumental in supporting various drug development activities for our clients. To excel in this role, you must have a minimum of 3-10 years of experience in the pharmaceutical industry. A background in Sciences or Engineering at the university level, complemented with a post-graduate degree in Biostatistics or equivalent statistical experience, is essential. Proficiency in SAS, R (and JMP), and a deep understanding of statistical theory across various methodologies and experimental designs are prerequisites for this position. We are looking for a team player who can effectively communicate and collaborate within multidisciplinary teams. Your role will involve contributing to the development of protocols, SAPs, and TFLs, as well as overseeing studies and ensuring timely delivery. Strong technical skills in power calculation, simulations, and QDM will be beneficial in fulfilling the requirements of this role. If you meet the qualifications mentioned above and are passionate about contributing to the acceleration of drug development activities with top-notch quality and cost-effectiveness, we invite you to share your resume with us at info@cpvia.com. Join our experienced and expert team at CPVIA to make a significant impact on the pharmaceutical and biotechnology sectors.,

COMPANY BACKGROUND Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis). We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others. Job Summary The Associate Director of Statistical Programming will be a key member of the clinical development team responsible for ensuring the accuracy and timeliness of programming deliverables for clinical studies. The incumbent will lead and manage statistical programming activities for clinical trial reporting, integrated safety/efficacy analysis, and global regulatory submissions. In addition, the incumbent will possess strong technical understanding of programming principles, documentation, SDTM/ADaM structure, and ICH GCP requirements. The main responsibilities of this position include development of analysis and dataset specifications, vendor management, and QC of key deliverables provided by CRO vendors while adhering to planned project timelines. As a key member of the clinical development and cross-functional teams, this position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders. Job Responsibilities Review and lead quality control (QC) of SAS programming deliverables and vendor management of CROs Development and manage timelines for statistical programming deliverables and associated documentation. Perform ad hoc analyses as requested. Represent statistical programming function at internal and external meetings Develop overall strategy regarding preparation and standardization of data packages for BLA submission(s) Qualifications Master’s degree or PhD in Statistics, Biostatistics, Mathematics, or other field with significant quantitative and scientific component. Exceptional BS-level candidates with commensurate industry experience may be considered. 8 years or more direct biotechnology or pharmaceutical industry experience in statistical programming, including vendor management experience (e.g. CROs) Expertise in CDISC (SDTM/ADaM) standards and implementation, regulatory requirements, and ICH GCP. Recent experience with BLA/NDA/MAA submission, as well as ISS/ISE development experience, is highly desirable Familiarity with hepatology, gastroenterology, or cardiometabolic therapeutic area is desirable Technical Requirements and Skills Proficient in MS Office Suite (Word, Excel and Power Point) Expertise in SAS programming (SAS base, macro, etc.), SDTM/ADaM data standards and documentation, and quality control. Fluency in at least one other statistical programming language such as R or Python, is a plus. Strong interpersonal and communication skills; proactive approach. Demonstrated problem solving skills (including taking ownership to ensure timely resolution with vendors), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures. Able to work both independently and in a team environment. Ability to work collaboratively with CROs and lead oversight of outsourced programming activities. Familiarity with modern ML/AI methodology (e.g. deep learning) and applications is a plus Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously. Ability to travel if needed (<20%) Compensation Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. Pay range: $200,000 - $209,000 per annum Special Advisory The FTC has an advisory out on the domain @akerotxhr.com and the email address akerotx@consultant.com. If you are contacted by any individual or group using email addresses or other contact information that incorporate “akerotx” but do not use our exact domain, akerotx.com, please submit a report to the FTC.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Works highly independent and performs critical assessments in collaboration with study teams or other departments to determine best approaches to manipulate subject data. The Assoc. Patient Data Specialist is capable of leading active and challenging interdepartmental discussions to explore best strategies and practices after understanding trial specific needs and diverse data bases that can be used as source of information. Reviews subject data from multiple sources with a data analytic mindset, capable of identifying trends, risks, gaps and areas for optimization as the subject data and the trial develops. Prepares and analyzes clinical trial patient datasets. Adapts to constant changes as trial develops. Capable of providing concise and clear updates to study teams and other key stakeholders after processing and reviewing subject data. Continually makes efforts to increase knowledge base and professional skills in areas such as programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles. The Assoc. Patient Data Specialist generates a thorough understanding of protocol schedule of events (visits, activities and procedures), EDC, Systems, Contracts, budgets and/or payment terms. Escalates performance issues to clinical, site payments and IT managers and may assist with resolution (Follows Escalation Pathway as applicable). Lead internal team meetings and provide updates on subject data statuses. Manage escalations (project team, site and sponsor) regarding tracking system setup/maintenance issues. Qualifications and Skills (some of the below are desired): Bachelor's degree in life science-related fields, Engineering, Biostatistics and/or Programing or related fields/degrees If possible (but not required), prior clinical research experience or related fields of minimum 6 months to 1 year or related experience involving knowledge of clinical trials. If possible (but not required), prior experience of minimum 6 months to 1year on process development or process improvement. If possible (but not required), prior experience of minimum 6 months to 1year on data assessments, analytics or critical assessments. Highly independent and capable of leading multidisciplinary discussions as needed. Comfortable with decision making and proper documentation practices. Capable of working under continuous pressure and continuous changing challenges adapting to new priorities and needs as they arise. If possible (but not required), experience with data bases with scientific background. Skills Understanding of data base structure and complex data systems Proven understanding and use of Microsoft Excel Capable of effectively capturing and reviewing data Capable of providing quality control support Good attention to detail Good problem-solving skills Excellent written and verbal communications skills to effectively interface with teams, including proficiency in the English language Capable of effectively organizing and managing multiple assignments with challenging timelines Capable of adapting and adjusting to changing priorities Positive attitude and the ability to work well with others Demonstrate initiative and self-motivation

Role & responsibilities Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably design of experiments feasible under given lab conditions, support of sample-size calculations and application for animal testing licenses, randomization, data transfer into appropriate stats software, interpretation of results. Takes statistical responsibility for one or more standard experiments. Develops the statistical analysis plan for the experiments as appropriate, ensuring overall consistency within and between projects. Facilitates the overall organization and coordination of statistical activities for specific experiments and small projects. Leads virtual cross-functional sub-teams within NCS/SIS of DS&AI. Assumes responsibility for the production and accuracy of the statistical deliverables and interpretation of the results. Works independently at routine and complex statistical questions and tasks. Develops and implements standard processes for the analysis of routine experiments. Oversees and ensures accurate and timely delivery of statistical work outsourced to external providers. What we're looking for Qualifications & Competencies: PhD or MSc in Biostatistics, Statistics or Mathematics, or related field. Strong communication skills. Ability to work independently as well as collaboratively, as required. Ability to translate statistical results into biological meaning Good knowledge of statistical programming languages (including SAS and R). Fluent English skills. At least two years as a non-clinical statistician focused on in vivo and in vitro experiments with significant time spent in pharma, biotech or similar sector.

Hello Candidate , We are #hiring for Project Research Scientist-I (Non Medical) ! Government Project Payroll company: - E Solutions Job role: - Project Research Scientist-I (Non Medical) ! Educational Qualification First Class M.Sc. In Life Sciences/Genetics/Clinical Research/Biostatistics from recognized University. Desirable Qualification Ph.D. in Life Sciences/Biotechnology/Microbiology with 2 years research experience, in immunology molecular biology techniques. No. of Vacancy :- 1 Age Limit: The upper age limit is 35 years Interested Candidate can share your CV on this Email ID :- anchal.g@esolglobal.com

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e.g. ADaM specifications) Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results Skills, knowledge, and experience Minimum Requirements: Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members. Preferred Requirements: Management experience supervising technical professionals. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing impact to ZS. Our most valuable asset is our people . At ZS we honor the visible and invisible elements of our identities, personal experiences and belief systems—the ones that comprise us as individuals, shape who we are and make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the messages they are passionate about. ZS’ R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations to achieve their passion for patient care, science and business success. Through our “Lifecycle Evidence Strategy”, “Clinical Trial Optimization”, “Medical Affairs” and “Evidence Generation” services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS’s R&D Excellence Practice Area, and particularly within our Evidence Generation practice, supporting our business consulting and analytics services across multiple clients. HEOR/Evidence Synthesis Lead: We seek applicants for a Evidence Synthesis Lead role. This is an important leadership role within our Health Economics and Outcomes Research (HEOR) team, part of our Evidence Generation practice. Our vision is to elevate HEOR into a strategic function which bridges the scientific, clinical and commercial spheres, and be the world leading strategic HEOR consultancy. As well as providing core HEOR services, we aim to shape the policy landscape HEOR operates within, be benevolent disruptors, driving the adoption of innovative new approaches, and make HEOR part of the entire product lifecycle. ZS has an inclusive, client centric, consultancy culture, based around our core values: Treat people right Get it right Do the right thing The successful candidate will be someone excited by and aligned to this vision and culture. Responsibilities: Leading evidence synthesis standalone projects and workstreams on broader engagements, as the person responsible for overall quality, timelines, and financial performance Developing recommendations based on expected impact, communicating risks and opportunities to ensure staff alignment, and where appropriate assuming the role of final decision maker Reviewing and signing off on deliverables including protocols, analysis plans, technical reports, and slides Work closely with ZS client teams to lead client business development and client relationship development across our key client accounts; Owning relationships with clients and being viewed as subject matter expert; proactively managing client expectations and working with team members to implement strategies to problem solve on a client or project-basis Leading team development and mentoring, encouraging a culture of open and constructive feedback, ensuring staff have clear pathway for career development Contributing to staffing discussions as well as long-term strategic planning in conjunction with other senior leaders Helping to develop and maintain processes required for the effective operation of the research team (e.g., onboarding, training, templates etc.) Supporting staff to effectively communicate within and across teams, resolving conflicts tactfully, and stimulating morale Providing methodological/subject matter input to and signing off on proposals and presentation content Establishing trusted partnerships with clients and driving new business opportunities Identifying opportunities for growth and recommendations for hiring that aligns with business development Play an active role in counseling and mentoring junior team members within ZS; Demonstrate ability to quickly assimilate new knowledge. May require travel domestically and/or internationally including overnight stays Qualifications : Bachelor’s degree in a relevant discipline MSc in relevant discipline preferred, e.g. health economics, public policy, health policy, epidemiology, biostatistics, or public health, or science (biology/biochemistry etc.) Minimum 10 years of directly relevant experience in a similar industry / consulting environment Demonstrates expert understanding of the pharmaceutical industry and requirements for health technology assessment, evidenced by a track record of relevant publications Demonstrated experience with Health Economics and Outcomes Research (HEOR) with a particular emphasis on health Evidence Synthesis - e.g. SLRs, ITCs, Dossier Writing etc. Good understanding of relevant methodologies and statistics Ability to lead and manage teams Ability to work seamlessly and collaboratively with teammates across our global practice Excellent communication and interpersonal skills Expertise in communicating HEOR findings in various forms (e.g., peer-reviewed publication, abstracts and conference presentations, HTA dossiers, PowerPoint presentations) Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying? At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To Complete Your Application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At: www.zs.com

The University of Hong Kong Apply now Ref.: 532532 Work type: Full-time Department: School of Public Health (22400) Categories: Executive / Technical / Support Hong Kong Assistant Project Manager (at the rank of Executive Officer) in the Division of Epidemiology and Biostatistics, School of Public Health (Ref.: 532532) (to commence on November 1, 2025, on a two-year fixed-term basis with contract-end gratuity and University contribution to a retirement benefits scheme, totalling up to 10% of basic salary, with the possibility of renewal subject to funding availability and satisfactory performance) Applicants should possess a good university degree with at least 3 years’ relevant experience in areas such as human resources, financial management, office management and research administration. Prior experience working across multiple tertiary institutions or research institutes is highly desirable. Candidates should demonstrate practical expertise in liaising with both public and private research funding bodies, including government agencies and large-scale philanthropic organizations at both local and international levels. A strong command of written and spoken English and Chinese, IT proficiency, and excellent interpersonal, communication and organization skills are required. The ideal candidates will be mature, meticulous and proactive, with a responsible and positive attitude. The appointee will be responsible for providing comprehensive administrative and secretarial support to the team, including but not limited to grant and award applications, contract research activities and multi-institutional projects. The role entails managing key operational aspects such as human capital, budgeting processes and other financial matters associated with the team and its projects. In addition, the appointee will assist in planning and coordinating a variety of academic and research-related events, such as seminars, conferences, forums, and short courses. He/She is also expected to collaborate effectively with research teams and administrative personnel at various levels, and to undertake other duties as assigned by supervisors. Shortlisted candidates will be invited to attend an interview and/or written test. A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits. The University only accepts online application for the above post. Applicants should apply online and upload an up-to-date C.V. Review of applications will start as soon as possible and continue until August 31, 2025 , or until the post is filled, whichever is earlier. Advertised: Jul 8, 2025 (HK Time) Applications close: Aug 31, 2025 (HK Time) Back to search results Apply now Whatsapp Facebook LinkedIn Email App

JOB DESCRIPTION Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics. Statisticians report to the Biostatistics Manager. QUALIFICATIONS FOR ESSENTIAL FUNCTIONS Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans. Design and verify randomization codes to support clinical trial integrity. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays. Provide specifications for the structure, content, and algorithms of status and analysis datasets. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM). Conduct independent validation of datasets created by other programmers or statisticians. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation. Manage electronic project directories to ensure organization and accessibility of deliverables. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard

Role Title: Programming Team Leader Reporting To: Associate Director, Statistical Programming Function: Data Management & Statistics Location:Remote Experience:4-8Years Purpose of the Role To ensure the accurate and timely execution of all statistical programming tasks by providing subject matter expertise and guiding a team of programmers. The role is responsible for generating statistical analyses from clinical databases, external data sources, and other relevant inputs in compliance with study protocols, statistical plans, regulatory guidelines, and internal processes to drive stakeholder satisfaction. Key Responsibilities & KPIs 1. Subject Matter Leadership Provide expert guidance on SDTM and ADaM development, ensuring alignment with the latest regulatory and industry standards (e.g., CDISC). Resolve complex issues related to dataset creation, transformation, and validation. Establish and maintain best practices for programming efficiency, reproducibility, and standardization. KPIs: Quality of programming deliverables (%) Stakeholder satisfaction (%) On-time task completion (%) Regulatory compliance (audit cases) Process improvements (#) Resolution of complex issues without escalation (#) Team training mandays (#) Voluntary attrition rate (%) 360° feedback results Training sessions conducted/attended (#) 2. Project Delivery Lead complex or high-priority programming tasks. Develop SAS programs for clinical trial outputs including TLFs, as per SAP. Conduct peer code reviews and optimize existing programs/macros for performance and efficiency. 3. Reporting Prepare comprehensive and timely management/statistical reports. Monitor data transfers during trials and address any issues proactively. Identify and escalate risks related to programming timelines and implement mitigation strategies. 4. Quality Assurance Establish and lead regular audits to ensure programming output and process quality. Execute data validation checks throughout the study lifecycle. Ensure accurate archiving of datasets, programs, and outputs post-study. 5. Policies, Processes & Procedures Maintain clear documentation of programming activities and dataset specifications. Ensure SOP adherence and correct any identified non-conformances. Implement new projects in line with department policies. Ensure compliance with Quality and Information Security Management Systems and applicable legal standards. 6. People Management Ensure technical and procedural training for all team members. Lead recruitment and foster team engagement and retention. Set team performance objectives, conduct appraisals, and provide feedback. Mentor team members for career growth and development. Recommend and support relevant training programs. Operating Network Internal: Department Heads External: None Role Requirements Education: Bachelor’s degree in Statistics, Mathematics, Biostatistics, Data Analysis, Data Science, or a related field. Master’s degree in the above fields is preferred. Experience: Minimum 8 years of SAS programming experience in clinical trials (CDISC standards), with at least 1–2 years of people management experience within a CRO, pharmaceutical, or related industry. Technical / Functional Competencies: SAS programming and statistical software SDTM/ADaM development Regulatory compliance (e.g., FDA, EMA) Project management Quality assurance Documentation and data interpretation Behavioral Competencies: Collaboration Communication Decision-making Problem-solving Coaching People management

The Lead Biostatistician is a key member of the Department of Biostatistics & Programming, responsible for performing all Biostatistics tasks essential for clinical trial analysis and reporting. Collaborating closely with the Statistical Programming, Data Management, and Product Development departments, this position involves leading projects across studies or programs. As the primary contact with the sponsor for all biostatistics related activities on assigned projects, you will direct the activities of other biostatisticians to ensure timely completion of high-quality work. Your responsibilities include providing statistical support for clinical studies, developing and reviewing statistical analysis plans, monitoring statistical analysis programs, and collaborating with functional management to meet project deliverables and timelines. In addition, you will perform all SAS programming required for analysis and reporting, plan and execute SAS programs to analyze clinical trial data, and conduct quality control checks on assigned tasks. Your role also involves maintaining high productivity on projects, identifying and communicating resource and quality issues, resolving data interpretation and reporting issues, complying with regulatory requirements, and independently solving technical problems. To qualify for this position, you should hold a minimum of a master's degree in Statistics and have at least 8 years of experience as a Biostatistician and Statistical Programmer for all clinical trial phases. Proficiency in industry standards, CDISC data standards, ICH-GCP guidelines, medical terminology, and clinical trial methodologies is essential for success in this role.,