59 jobs for Regulatory Submissions

Senior/Principal Statistical Programmer FSP (SAS + R) PLN 264K-321K

ADaM | Biostatistics | CDISC | CRF | Clinical Practice

Autonomy | Ownership | Support from project team | Training and development

Senior-level Full Time

Poland

2d ago

Principal Statistician - Early Phase A EUR 72K-80K

Analysis Plan | Analysis dataset | Biostatistics | Clinical Trial Design | Clinical trial

Career development | Flexible work arrangements | Fully remote | International collaboration | Mentorship

Senior-level Full Time

Germany R

4d ago

Principal Statistician - Early Phase A EUR 58K-86K

Analysis Plan | Analysis datasets | Biostatistics | Clinical Trial Design | Clinical trial

Career development | Flexible work arrangements | Fully remote | Global collaboration | Inclusive workplace culture

Senior-level Full Time

Ireland R

4d ago

Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery USD 109K-174K

510(k) | Biocompatibility | De Novo | Design Controls | Device Design

401k | Hybrid work schedule | Paid time off | Relocation assistance | Retirement plan

Senior-level Full Time

US052 OH Cincinnati - 4545 Creek … R

4d ago

Principal Biostatistician FSP - Real World Evidence INR 1500K-2400K

Analysis Dataset Specification | Analysis Plan | Analysis dataset | Biostatistics | Clinical trials

Development | Support | Training

Senior-level Full Time

India

4d ago

Biostatistical Programming Associate INR 885K-1500K

Automation | CDISC ADaM | CDISC Define | CDISC SDTM | Clinical data

Career development opportunities | Health insurance | Work-life balance

Mid-level Full Time

India - Hyderabad

5d ago

Senior Statistical Programmer INR 2486K-4144K

CDISC | Clinical data | Clinical trials | Regulatory Submissions | SAS

Flexible work schedule | Hybrid work | In office collaboration days per week

Senior-level Full Time

India - Bangalore

6d ago

Senior Manager, Biostatistical Programming INR 2475K-3500K

Automation | Clinical Trial Operations | Clinical trial | Compliance checks | Data Quality

Career development | Generous total rewards | Health benefits | Work-life balance

Senior-level Full Time

India - Hyderabad

6d ago

Biostatistical Programming Manager INR 2475K-4000K

CDISC ADaM | CDISC SDTM | Clinical trials | Data Quality | Define-XML

Career growth | Diversity and inclusion | Health benefits | Training and development | Work-life balance

Senior-level Full Time

India - Hyderabad

6d ago

Biostatistical Programming Senior Associate INR 2475K-3500K

CDISC ADaM | CDISC Define | CDISC SDTM | Clinical data | Clinical data standards

Career development opportunities | Health benefits | Inclusion and diversity | Work-life balance

Senior-level Full Time

India - Hyderabad

7d ago

Principal Statistical Programmer USD 109K-179K

Analysis datasets | Clinical data | Clinical data management | Data Analysis | Data Documentation

Senior-level Full Time

Warren, United States

7d ago

Statistical Science Director V&I USD 188K-282K

Biostatistics | Clinical trials | Cross-Functional Collaboration | Cross-functional | Data Interpretation

Dental insurance | Equity awards | Health insurance | Incentive bonuses | Paid time off

Executive-level Full Time

US - Gaithersburg - MD, United …

10d ago

Principal Biostatistician/Senior Principal Biostatistician CAD 125K-175K

21 CFR | 21 CFR Part 11 | Adaptive study design | Analysis Plans | Bayesian adaptive study design

Disability benefits | Discretionary annual bonus | Health insurance | Life insurance | Paid time off for sick leave

Senior-level Full Time

Remote, Canada R

10d ago

Principal Biostatistician/Senior Principal Biostatistician CAD 125K-175K

21 CFR | 21 CFR Part 11 | Adaptive Design | Analysis Plan | Bayesian adaptive design

Disability benefits | Health insurance | Life insurance | Paid time off | Parental leave

Senior-level Full Time

Remote, Canada R

10d ago

Principal Statistical Programmer FSP INR 1314K-2200K

CDISC | CDISC ADaM | CDISC SDTM | CDISC Terminology | CRF development

Training development support

Senior-level Full Time

India

10d ago

Manager, Statistical Programming (Must require skills: SDTM datasets, ADaM datasets, TLFs) INR 850K-1250K

ADaM | Clinical trial | Data Standards | Metrics and KPIs | Project Management

Remote work | Work-life balance

Mid-level Full Time

Bengaluru, KA, India

10d ago

Principal Biostatistician INR 3000K-4000K

Analysis Plan | Biostatistics | Clinical Reporting | Inferential analysis | Oncology trials

Disability coverage | Employee Assistance programmes | Health and Wellbeing Programmes | Learning and development opportunities | Life assurance

Senior-level Full Time

India, Bangalore

11d ago

Senior Statistician EUR 63K-84K

Clinical Trial Design | Clinical trial | Modelling | Preclinical Study | Preclinical Study Analysis

Conference participation | English fluency required | Journal publication opportunities | Onsite three days per week

Senior-level Full Time

Spain - Barcelona

11d ago

Principal Statistician, Global Rare Diseases EUR 59K-59K

Adaptive Design | Analysis Plan | Bayesian Methods | Biostatistics | CDISC

Flexible benefits | Pension | Private medical insurance | Relocation support | Remote work

Senior-level Full Time

Parma, IT

12d ago

Principal Statistical Programmer FSP INR 2000K-3465K

ADaM | Biostatistics Programming | CDISC | CRF | Clinical Study Reporting

Senior-level Full Time

India

12d ago

Associate Director, Analytical Development- Separation Assays USD 133K-189K

AAV gene therapy | Analytical Method Development | Analytical method transfer | Analytical method validation | Capillary electrophoresis

401k with company match | Dental insurance | Employee assistance program | Equity | Family building benefits

Mid-level Full Time

Research Triangle Park, NC

12d ago

Manager, Statistical Data Sciences Lead (PM) PHP 150K-200K

ADaM | CDISC | Clinical Trial Programming | Clinical trial | Data Visualization

Senior-level Full Time

PHL - Makati City, Philippines

13d ago

Senior Manager Statistical Programming USD 150K-245K

Clinical Development | Clinical Trial Data | Clinical trial | Python | R

Senior-level Full Time

Warren, United States

13d ago

Biostatistical Programming Senior Associate INR 2486K-4064K

CDISC ADaM | CDISC Define | CDISC SDTM | Clinical trials | Data Quality

Career development | Diversity and inclusion | Health benefits | Total Rewards plan | Work-life balance

Senior-level Full Time

India - Hyderabad

14d ago

Regulatory Data Steward & Team Lead (Secondment - 12 Months) USD 124K-207K

Biopharmaceuticals | Change Management | Data Auditing | Data Governance | Data Management

Senior-level Full Time

USA - CT - Groton, United …

14d ago

Senior Statistical Programmer USD 110K-176K

Clinical trials | Data Management | Data Validation | GCP | ICH

401k plan | Dental coverage | Educational assistance | Employee assistance program | Flexible spending accounts

Senior-level Full Time

USA NJ - Franklin Lakes, United …

18d ago

Senior Principal Statistician, Biometrics USD 191K-225K

Biostatistics | Causal Inference | Clinical trials | Data Analysis | External Control

Flexible benefits | Learning and development opportunities | Paid parental leave | Reimbursement for tuition | Wellness benefits

Senior-level Full Time

Parsippany, New Jersey, United States

20d ago

Statistical Programming Director USD 168K-253K

Automation | Clinical Development | Information Management | Regulatory Submissions | Risk Management

Dental insurance | Health insurance | Paid time off | Retirement programs | Vision insurance

Executive-level Full Time

US - Gaithersburg - MD, United …

20d ago

Senior Manager, Biostatistics USD 164K-228K

Analysis Plan | Clinical Trial Design | Clinical trial | Data Interpretation | Data Manipulation

401k plan | Disability insurance | Employee assistance program | Flexible work options | Life insurance

Senior-level Full Time

Princeton Pike - NJ, United States

20d ago

Associate Director, QC (Analytical Technical Lead) Global Analytics USD 176K-206K

Analytical Chemistry | Analytical Methods | Audit Readiness | By Design | Critical Quality Attributes

Comprehensive benefits | Equity component | Hybrid work

Mid-level Full Time

San Carlos, California, United States

20d ago

Associate Director Statistical Programming USD 176K-287K

Clinical Development | Clinical data | Clinical data management | Data Management | People management

401k company match | Family support benefits | Fitness centers | Health and wellness programs | Hybrid work model

Mid-level Full Time

Warren, United States

23d ago

Principal Biostatistician PLN 271K-329K

ADaM | Analysis Plan | BLA | Clinical Trial Design | Clinical trial

Paid training | Remote work | Work-life balance

Senior-level Full Time

Warsaw, Masovian Voivodeship, Poland

26d ago

Principal Biostatistician BGN 84K-90K

ADaM | Analysis Plan | Clinical Protocol | Clinical Trial Design | Clinical trial

Career development | Cross-functional collaboration | Remote work | Work-life balance

Senior-level Full Time

Sofia, Sofia City Province, Bulgaria

26d ago

Principal Biostatistician EUR 55K-90K

ADaM | Analysis Plan | BLA | Biostatistics | Clinical Protocol

Senior-level Full Time

Zagreb, Croatia

26d ago

Principal Biostatistician CZK 915K-1473K

Analysis Plan | Biostatistics | Clinical Study Design | Clinical study | Clinical trials

Senior-level Full Time

Prague, Prague, Czechia

26d ago

Senior Manager Biostatistical Programming

Automation | Clinical trials | Compliance | Data Quality | Offshore Team Management

Career development | Career growth | Diversity and inclusion | Health insurance | Learning opportunities

Senior-level Full Time

Taiwan - Taipei

27d ago

Associate Director Biostatistics

AI | Analysis Plan | Biostatistics | Clinical Trial Design | Clinical study

Mid-level Full Time

Taiwan - Taipei

27d ago

Principal Statistical Programmer USD 149K-223K

Base SAS | CDISC | Clinical Data Analysis | Clinical data | Clinical trials

401k matching | Annual bonus | Annual equity awards | Commuting subsidy | Educational assistance

Senior-level Full Time

5000 - Vertex US - Fan … R

28d ago

Principal Biostatistician USD 151K-171K

Analysis Plan | Biostatistics | CDISC | CRO Management | Clinical trials

Hybrid work schedule | Onsite minimum 3 days per week | Well-being benefits

Senior-level Full Time

Americas, US-PA, King of Prussia, CSL …

28d ago

Senior Biostatistician USD 144K-180K

Analysis Plan | Analysis datasets | CDISC | CDISC ADaM | CDISC STDM

401k match | Dental insurance | Disability insurance | Employee assistance program | Employee discounts

Senior-level Full Time

El Segundo CA Mariposa, United States

28d ago

Lead Biostatistician (IVD Clinical) USD 144K-180K

Analysis Plan | Biostatistics | Clinical Trial Design | Clinical trial | Data Analysis

401k match | Annual performance incentive bonus | Baby bonding leave | Company holidays | Dental insurance

Senior-level Full Time

San Carlos, CA

1mo ago

Lead Biostatistician (IVD Clinical) USD 130K-163K

Biostatistics | Clinical Trial Design | Clinical trial | Document Authoring | FDA

401k benefits | Commuter benefits | Comprehensive medical, dental, vision | Disability insurance | Employee referral program

Senior-level Full Time

US Remote R

1mo ago

Associate Director, Quantitative Clinical Pharmacology (QCP) Lead USD 154K-242K

Clinical Pharmacology | Clinical Practice | Clinical Trial Design | Clinical trial | Data integration

401k plan | Dental insurance | Medical insurance | Paid vacation | Paid volunteer time off

Mid-level Full Time

USA - MA - Cambridge, United …

1mo ago

Associate Director, Quantitative Clinical Pharmacology (QCP) Lead USD 154K-242K

Bayesian Methods | Clinical Practice | Clinical Trial Design | Clinical trial | Clinical trial analysis

Hybrid work policy

Mid-level Full Time

Boston, Massachusetts

1mo ago

Senior Manager, Statistical Programming - Oncology Early Development USD 121K-230K

ADaM | CDISC | Clinical data | Regulatory Submissions | SAS

401k | Paid time off

Senior-level Full Time

South San Francisco, CA, United States

1mo ago

Biostatistical Programming Manager INR 2000K-3465K

Automation | CDISC ADaM | CDISC Define | CDISC SDTM | CRF

Career development | Finance and wealth benefits | Health benefits | Work-life balance

Senior-level Full Time

India - Hyderabad

1mo ago

Statistical Programmer II INR 1200K-2168K

21 CFR | 21 CFR Part 11 | ADaM | Base SAS | Batch scripting

Senior-level Full Time

Bangalore, Karnataka

1mo ago

Associate Director, Analytical Development (Biologics) USD 172K-215K

Analytical Chemistry | Binding assays | Biologics CMC | CE-SDS | CGMP

Mid-level Full Time

South San Francisco, California, United States

1mo ago

Principal Statistical Programmer CAD 125K-175K

ADaM | CDISC | CDISC Compliance Checks | Clinical data | Clinical data standards

Accidental death and dismemberment insurance | Dental insurance | Employee assistance program | Fitness reimbursement | Life insurance

Senior-level Full Time

Markham, Ontario, Canada; Remote, Canada R

1mo ago

Associate Director, Statistical Programming USD 170K-205K

ADaM | Agency support | Biometrics | Biostatistics | CDISC

401k retirement plan | Disability insurance | Employee assistance program | Fitness reimbursement | Life insurance

Mid-level Full Time

Bridgewater, New Jersey, United States; Remote, … R

1mo ago

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