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Syneos Health Mega Hiring 2026: 4 Openings in Clinical SAS Programming, Pharmacovigilance (PV), Clinical Research
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Syneos Health (Clinical Solutions) |
| Recruitment Drive | Mega Hiring 2026 – 4 Strategic Openings |
| Target Qualifications | B.Pharm, M.Pharm, M.Sc Statistics, Mathematics, Computer Science, Life Sciences |
| Work Locations | Hyderabad, Telangana & 100% Remote (India Anywhere) |
| Operational Modes | 100% Remote / Hybrid / On-Site |
| Application Channel | Official Direct Employer Portal (Workday ATS) |
Verified Vacancy Matrix & Hiring Tracks
Review all active hiring tracks below. Direct official application links for each position are provided at the bottom of this notification:
| # | Designation & Hiring Track | Work Location | Experience & Mode |
|---|---|---|---|
| 1 |
#1Clinical Document Agent (Clinical Documentation Specialist)
Clinical Research |
Location: 100% Remote Work from Home
|
Experience: 1 – 3 Yrs Online Portal
|
| 2 |
#2Statistical Programming Roles
Clinical SAS Programming |
Location: Hyderabad
|
Experience: 4-12+ Yrs Online Portal
|
| 3 |
#3Medical Writer I & II (CSR & Patient Narratives)
Medical Writing |
Location: Hyderabad
|
Experience: 1-4 Yrs Online Portal
|
| 4 |
#4Safety & PV Specialist (Japanese Language)
Pharmacovigilance (PV) |
Location: Hyderabad
|
Experience: 3-6 Yrs Online Portal
|
Key Roles & Detailed Responsibilities
- Execute end-to-end clinical data operations, trial documentation, or statistical programming workflows strictly aligned with Syneos Health’s Standard Operating Procedures (SOPs).
- Ensure 100% adherence to global regulatory frameworks including ICH-GCP guidelines, USFDA 21 CFR Part 11, and CDISC SDTM/ADaM submission standards.
- Perform technical quality reviews, trial master file (TMF) audits, safety event reconciliation, and clinical database validation deliverables.
- Collaborate cross-functionally with biostatisticians, clinical data managers, medical writers, and enterprise safety review boards.
Eligibility Criteria & Candidate Profile
- Academic Qualifications: Candidates must possess B.Pharm, M.Pharm, M.Sc Statistics, Mathematics, Computer Science, Life Sciences from an accredited university or approved technical institution.
- Experience Profile: 1 to 12+ Yrs (Freshers & Experienced Tracks) with demonstrated hands-on technical proficiency in target operational workflows.
- Regulatory & Quality Knowledge: Solid foundational awareness of pharmaceutical compliance (cGMP, ICH-GCP, GLP, 21 CFR Part 11, or CDSCO standards).
- Core Competencies: Excellent analytical problem-solving skills, rigorous documentation hygiene, and strong verbal/written technical communication.
Core Technical Competencies & Instruments Matrix
Candidates possessing hands-on proficiency across the following analytical tools, software systems, and regulatory standards will receive priority evaluation:
Base SAS & Advanced SAS Macro ProgrammingCDISC SDTM Implementation Guide (IG 3.2 / 3.3 Standards)CDISC ADaM Implementation Guide (IG 1.1 / OCCDS Models)Generation of Tables, Listings, and Figures (TLFs / TFLs)PROC SQL, PROC REPORT & Data Step Programming AlgorithmsDefine.xml 2.0 & Reviewer’s Guides (SDRG / ADRG)Pinnacle 21 Community & Enterprise Validation SuitesStatistical Analysis Plan (SAP) & Mock Shells ExecutionSafety & Efficacy Endpoint Derivation LogicElectronic Common Technical Document (eCTD) Module 5 Standards
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for Mega Hiring 2026: 4 Openings in Clinical SAS Programming, Pharmacovigilance (PV), Clinical Research:
Duty 1SAP & Mock Shells Analysis
Reviewing the Statistical Analysis Plan (SAP) and mock shells to map required table, listing, and figure (TLF) programming specifications.
Duty 2CDISC SDTM Dataset Mapping
Writing SAS programs to transform raw clinical trial datasets into standardized SDTM domains (DM, AE, LB, VS, CM, EX) adhering to SDTM IG.
Duty 3ADaM Analysis Dataset Derivation
Developing analysis datasets (ADSL, BDS, OCCDS) with full variable derivation, imputation, and source traceability.
Duty 4TLF Output Generation
Writing validated SAS macros and PROC REPORT scripts to generate production-quality summary tables and listings for CSRs.
Duty 5Pinnacle 21 Validation & QC
Running automated Pinnacle 21 validation checks, resolving data structure anomalies, and generating Define.xml metadata.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
CDISC SDTM & ADaM Standards
Clinical Data Interchange Standards
Standardized domain structures required by global regulatory agencies (USFDA, PMDA) for clinical trial data submission.
FDA Study Data Technical Conformance Guide
Submission Conformance Rules
Regulatory technical rules governing dataset formatting, variable length, terminology versions, and SDRG/ADRG documentation.
Define.xml v2.0 / v2.1 Specifications
Dataset Metadata Standards
Standard XML architecture describing dataset structures, variable derivation algorithms, and value-level metadata.
USFDA 21 CFR Part 11
Electronic Computing Compliance
Validation of statistical macros, program code change audit trails, reproducible log files, and archive repositories.
Remote Career Framework: How to Get Remote Jobs Easily (Complete Blueprint for Freshers & Experienced)
Tailored Resume Guidelines for Mega Hiring 2026: 4 Openings in Clinical SAS Programming, Pharmacovigilance (PV), Clinical Research
- Highlight Core Technical Instrumentation & Software: Explicitly mention hands-on software platforms (Empower 3, SAS, Argus, EDC Rave) or laboratory equipment relevant to 4 Openings at the top of your resume.
- Quantify Accomplishments & Throughput: Instead of passive duty descriptions, quantify measurable deliverables (e.g., ‘Validated 15+ analytical methods per ICH Q2’, ‘Processed 120+ clinical safety ICSRs per month’, ‘Supervised 50+ commercial batches with zero deviations’).
- Standardize on ATS-Friendly Clean Formatting: Use standard single-column reverse-chronological format with clean bullet points. Strictly avoid multi-column layouts, graphics, icons, or text boxes that confuse automated enterprise ATS parsers.
- Calibrate Regulatory Terminology: Integrate exact industry compliance acronyms (e.g., cGMP, ICH-GCP, ALCOA+, 21 CFR Part 11, USFDA audit readiness) naturally throughout your project and experience narratives.
Technical Interview Assessment & Guidance
Q: What is the structural difference between CDISC SDTM and ADaM datasets in clinical trial reporting?
Authoritative Answer: SDTM (Study Data Tabulation Model) standardizes raw electronic Case Report Form (eCRF) clinical trial data into standardized domain models (Interventions, Events, Findings) with minimal manipulation to facilitate regulatory review. In contrast, ADaM (Analysis Data Model) derives analysis-ready datasets from SDTM datasets with built-in traceability. ADaM datasets (such as ADSL for subject-level, BDS for Basic Data Structure, and OCCDS for occurrence data) include derived variables, change from baseline, imputed values, and treatment flags so that statistical tables, listings, and figures (TLFs) can be directly produced with one-proc calls without further data transformation.
Authoritative Answer: SDTM (Study Data Tabulation Model) standardizes raw electronic Case Report Form (eCRF) clinical trial data into standardized domain models (Interventions, Events, Findings) with minimal manipulation to facilitate regulatory review. In contrast, ADaM (Analysis Data Model) derives analysis-ready datasets from SDTM datasets with built-in traceability. ADaM datasets (such as ADSL for subject-level, BDS for Basic Data Structure, and OCCDS for occurrence data) include derived variables, change from baseline, imputed values, and treatment flags so that statistical tables, listings, and figures (TLFs) can be directly produced with one-proc calls without further data transformation.
Q: How do you ensure complete traceability between an ADaM dataset, SDTM source variables, and the Statistical Analysis Plan (SAP)?
Authoritative Answer: Traceability is achieved both horizontally (within a record) and vertically (across records). In ADaM, variables such as `–SEQ` link back to SDTM source records, while standard prefixes and suffixes (e.g. PARAM, PARAMCD, AVAL, BASE, CHG) explicitly document transformations. Furthermore, Define.xml 2.0 documents the precise derivation algorithm, machine-readable computation code, and references to specific sections of the SAP. Any non-standard derivation is explained in detail in the Analysis Data Reviewer’s Guide (ADRG).
Authoritative Answer: Traceability is achieved both horizontally (within a record) and vertically (across records). In ADaM, variables such as `–SEQ` link back to SDTM source records, while standard prefixes and suffixes (e.g. PARAM, PARAMCD, AVAL, BASE, CHG) explicitly document transformations. Furthermore, Define.xml 2.0 documents the precise derivation algorithm, machine-readable computation code, and references to specific sections of the SAP. Any non-standard derivation is explained in detail in the Analysis Data Reviewer’s Guide (ADRG).
Q: What are the most common Pinnacle 21 validation errors encountered in SDTM/ADaM and how do you resolve them?
Authoritative Answer: Common Pinnacle 21 errors include non-conformance to CDISC Controlled Terminology (e.g. invalid units or AE severity terms), missing required or expected variables (e.g. missing STUDYID or USUBJID), duplicate records on key domain variables, dates not conforming to ISO 8601 format (YYYY-MM-DDThh:mm:ss), and inconsistent subject identifiers across domains. Resolutions involve updating the mapping specification, aligning with the current NCI CT terminology dictionary, or documenting benign agency-accepted anomalies in the Study Data Reviewer’s Guide (SDRG).
Authoritative Answer: Common Pinnacle 21 errors include non-conformance to CDISC Controlled Terminology (e.g. invalid units or AE severity terms), missing required or expected variables (e.g. missing STUDYID or USUBJID), duplicate records on key domain variables, dates not conforming to ISO 8601 format (YYYY-MM-DDThh:mm:ss), and inconsistent subject identifiers across domains. Resolutions involve updating the mapping specification, aligning with the current NCI CT terminology dictionary, or documenting benign agency-accepted anomalies in the Study Data Reviewer’s Guide (SDRG).
Mandatory Documents Checklist for Interview & Verification
Ensure you organize the following original credentials and self-attested photocopies for technical interviews and HR onboarding verification:
Curriculum Vitae (2 Hard Copies)
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Academic Certificates & Marksheets
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Government Photo Identification
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Past 3 Months Salary Slips & Bank Records
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Relieving & Appointment Letters
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Passport Photographs & Professional Registration
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
Frequently Asked Questions (FAQ)
Q: What is the official application procedure for 4 Openings at Syneos Health?
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Syneos Health’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Syneos Health’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Q: What academic backgrounds and degrees are eligible for this hiring drive?
Answer: Eligible qualifications include B.Pharm, M.Pharm, M.Sc Statistics, Mathematics, Computer Science, Life Sciences. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Answer: Eligible qualifications include B.Pharm, M.Pharm, M.Sc Statistics, Mathematics, Computer Science, Life Sciences. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Q: What is the typical interview and shortlisting workflow?
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for Mega Hiring 2026: 4 Openings in Clinical SAS Programming, Pharmacovigilance (PV), Clinical Research at Syneos Health:
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Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for Mega Hiring 2026: 4 Openings in Clinical SAS Programming, Pharmacovigilance (PV), Clinical Research at Syneos Health above.
- Calibrate your resume to highlight relevant instrumentation, software platforms, or cGMP/GCP regulatory compliance.
- Ensure your contact details, active mobile number, and email address are up to date in your CV.
- Click the official application button below to access the direct employer recruitment portal or HR email channel with zero intermediary charges.
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