{"id":2479770,"url":"https://alion.io/job/takeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead","title":"GCM Evidence Generation Study Design & Execution Lead","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":55,"ghost_share":0,"stale_share":0.473,"repost_share":0.018,"time_to_fill_p50_days":27,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Design","role_family":"Design","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":33000,"max_usd":66000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":15},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CDISC","optional":false},{"name":"Machine Learning","optional":false},{"name":"Python","optional":false},{"name":"SAS","optional":false},{"name":"SQL","optional":false}],"status":"live","first_seen_at":"2026-10-13T22:24:33Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-31T11:08:44Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description\nRole Objectives:\nAs one of the first Statistics for Study Design and Execution Leads to join the Bengaluru GCM team, this role will establish the statistical capability required to support evidence generation study design and execution, covering statistical analysis plan development, programming, and real-world data analysis.\nYou will also provide hands-on statistical design and programming support across the evidence generation portfolio, enabling Global Evidence Generation study teams to focus on scientific leadership, endpoint strategy, and final study decisions while GCM delivers analytical execution, statistical planning documentation, and RWD methodology support.\nKey Responsibilities:\nInitial Capability Build\nIn the early build phase, work closely with Global Evidence Generation study leads and R&D statistical counterparts to document the scope, standards, tools, templates, and handoff protocols that will govern statistical support activities performed by the GCM going forward \nDevelop programming standards, analysis templates, SAP shells, output shells, and QC checklists to support consistent and reproducible statistical execution as the team scales to two Leads \nIdentify gaps in tool access, data system connectivity, or methodology guidance that need to be resolved before statistical activities can be fully transitioned to the GCM and flag these to the AD in a timely manner \nSupport with development of SOPs and onboarding materials for all statistical programming and RWD analysis activities\nStatistical Analysis Planning & Study Design Support\nDefine appropriate statistical methods for RWD analyses and draft statistical analysis plans in collaboration with the subject matter expert to address evidence generation needs across the drug development life cycle\nLead the implementation of analytic plans, execute analyses for RWE studies using appropriate data sets, as well as standardized methods aligned with GxP for insights, publications, regulatory and payer submissions\nHelp design interventional and non-interventional (real world) studies, including (where appropriate) sample size calculations and probability of success\nDevelop and update HTA CTAP (clinical trial analysis plan), post-hoc analysis, and pre-specified analyses\nWork on responder analyses using machine learning\nSupport external controls \nReview draft study protocols and synopses for statistical consistency and flag methodological gaps or assumptions requiring retained scientific review and resolution\nDocument all statistical planning decisions, assumptions, and rationale in study files in line with repository and audit standards\nStatistical Programming & Analysis Execution\nGenerate analysis-ready datasets based on defined use cases and implement analytical methods producing guideline-compliant outputs - including tables, listings, and figures (TLFs) with all data preparation steps documented and traceable throughout \nWrite, validate, and execute programs in SAS, R, or Python per the Statistical Analysis Plan (SAP); conduct exploratory and ad hoc analyses as requested, clearly documenting assumptions, scope, and limitations for each \nSupport comparative effectiveness analyses, subgroup analyses, and health economic modeling by providing analytical execution and output production; identify and address common sources of bias in collaboration with the retained statistical SME, testing appropriately for effect modifiers and documenting methodology choices and rationale \nDevelop and validate statistical models that appropriately account for intercurrent events, competing risks, and multiple comparisons; conduct sensitivity and robustness analyses as appropriate, flagging results and implications clearly for retained scientific interpretation and reporting decisions \nEnsure all analytical steps are fully reproducible and auditable for regulatory, HTA, or other external review by maintaining complete programming logs, data lineage records, and version control across all programs, datasets, and outputs throughout the study lifecycle \nQualifications:\nExperience: >3 years of related work experience; >2 years of experience in the biopharmaceutical industry; hands-on experience in biostatistics, statistical programming, or RWD analysis in a pharmaceutical, CRO, or HEOR context required; experience supporting study design and execution in an evidence generation, clinical development, or outcomes research setting strongly preferred\nTechnical skills:\nKnowledge of QC HTA-aligned analyses for payer/reimbursement evidence (e.g. PICO framework, Network meta-analyses, IPTW indirect treatment comparisons).\nKnowledge of statistical analysis methods, experimental design and data processing software for both clinical trials and non-interventional studies\nExpertise in SAS, R, SQL, Python, epidemiology, outcomes research, US secondary data sources, etc.\nStandards: CDISC, ADaM, PICO, HTA alignment\nFamiliarity with and hands-on experience working on a variety of real-world data sources: Claims, EHR/EMR, registries, observational databases.\nExperience with real-world dataset management\nAbility to QC and review other statisticians/analysts’ outputs\nStatistical programming of clinical and real-world data for Phase IV trials, observational studies, and RWE research\nEducation: Master’s/PhD in public health, health outcomes, statistics, or epidemiology; experience with Python, SAS, or R\nBenefits\nIt is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:\nCompetitive Salary + Performance Annual Bonus\nFlexible work environment, including hybrid working\nComprehensive Healthcare Insurance Plans for self, spouse, and children\nGroup Term Life Insurance and Group Accident Insurance programs\nHealth & Wellness programs including annual health screening, weekly health sessions for employees.\nEmployee Assistance Program\n5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves\nBroad Variety of learning platforms \nDiversity, Equity, and Inclusion Programs\nNo Meeting Days\nReimbursements - Home Internet & Mobile Phone\nEmployee Referral Program\nLeaves - Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)\nAbout ICC in Takeda\nTakeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.\nAs an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.\nLocations\nIND - Bengaluru\nWorker Type\nEmployee\nWorker Sub-Type\nRegular\nTime Type\nFull time\nLocations\nIND - Bengaluru - Research and Development\nWorker Type\nEmployee\nWorker Sub-Type\nRegular\nTime Type\nFull time\nLocations\nIND - Bengaluru\nWorker Type\nEmployee\nWorker Sub-Type\nRegular\nTime Type\nFull time\nLocations\nIND - BengaluruWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull time","description_format":"text","description_chars":7406,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible schedule","Hybrid work","Life insurance","Wellness"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-13T22:24:33Z"}],"visa":[],"liveness":{"score":76,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.847,"p_room":0.9,"age_days":17,"expected_fill_days":27,"reasons":["conf:3","velocity","win:mid","comp:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/takeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead","json_url":"https://alion.io/job/takeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead.json","meta":{"generated_at":"2026-10-31T19:28:47Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":30682,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5984},"rest":"https://alion.io/mcp/rest/get_company?id=5984"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftakeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ftakeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ftakeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/takeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftakeda-pharmaceutical-gcm-evidence-generation-study-design-execution-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2479770}},{"tool":"search_jobs","arguments":{"company":"takeda.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2479770},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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