Full-Time

Senior Statistical Programmer I

Confirmed live in the last 24 hours

AstraZeneca

AstraZeneca

10,001+ employees

Develops and commercializes prescription medicines

No salary listed

Senior

Bengaluru, Karnataka, India

Category
Computational Biology
Biology Lab & Research
Biology & Biotech
Required Skills
SAS
Risk Management
Data Analysis
Requirements
  • Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area
  • Strong experience in clinical drug development or healthcare
  • Advanced SAS Programming, CDISC standards knowledge and industry best practices
  • Excellent interpersonal skills.
Responsibilities
  • Lead Statistical programming deliverables for Regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements
  • Lead Statistical programming deliverables for Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations
  • Lead Statistical programming deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
  • Contribute to the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
  • Contribute to the development of standard methodology to improve quality, efficiency and effectiveness
  • Measure compliance to standards and automation use
  • Employ good project management practices (estimation, risk management, status tracking) when planning and leading delivery
  • Hold CRO/Partners accountable for the high-quality standards of their deliverables.
Desired Qualifications
  • Experience working in the Respiratory or Immunology therapeutic area
  • Other programming languages e.g., S-PLUS, R, Python, XML etc.
  • Extensive knowledge of Pinnacle 21 Validator

AstraZeneca focuses on discovering, developing, and selling prescription medicines. The company specializes in three main areas: Oncology, which deals with cancer treatment; Cardiovascular, Renal & Metabolism, which addresses heart, kidney, and metabolic diseases; and Respiratory & Immunology, which targets lung and immune system diseases. Their products are developed through extensive research and development, involving rigorous clinical trials and regulatory approvals before reaching the market. AstraZeneca differentiates itself from competitors by investing heavily in scientific research and forming strategic partnerships to enhance drug discovery. Their goal is to advance healthcare by creating effective treatments for serious diseases and collaborating with other organizations to improve their research capabilities.

Company Size

10,001+

Company Stage

IPO

Headquarters

Cambridge, United Kingdom

Founded

1913

Simplify Jobs

Simplify's Take

What believers are saying

  • Opening of $300M CAR-T facility in Rockville boosts cell therapy capabilities.
  • Enhertu's success in DESTINY-Breast11 trial strengthens AstraZeneca's oncology portfolio.
  • AI-powered lung cancer detection tool enhances early diagnosis and treatment options.

What critics are saying

  • Discontinuation of CAPItello-280 trial impacts oncology pipeline and investor confidence.
  • Operational challenges may delay CAR-T facility's production scale-up.
  • AI-powered tools may face scrutiny over data privacy and accuracy.

What makes AstraZeneca unique

  • AstraZeneca's A.Catalyst Network fosters global collaboration and innovation in healthcare.
  • The company invests heavily in R&D to create new drugs and therapies.
  • AstraZeneca's Open Innovation program accelerates drug discovery by sharing resources with scientists.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Vacation

Paid Holidays

Flexible Work Hours

Company News

MocoShow
May 9th, 2025
AstraZeneca Opens $300 Million CAR-T Manufacturing Facility in Rockville, Creating Over 150 Jobs

AstraZeneca opens $300 million CAR-T manufacturing facility in Rockville, creating over 150 jobs.

Cision
May 9th, 2025
Imfinzi Improved Dfs In Early Bladder Cancer

Imfinzi improved DFS in early bladder cancer

PharmiWeb
May 7th, 2025
Enhertu Followed By Thp Before Surgery Showed Statistically Significant And Clinically Meaningful Improvement In Pathologic Complete Response In Patients With High-Risk Her2-Positive Early-Stage Breast Cancer In Destiny-Breast11 Phase Iii Trial

AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of careFirst Phase III trial to demonstrate benefit of Enhertu in early breast cancer. Positive high-level results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment. The secondary endpoint of event-free survival (EFS) was not mature at the time of analysis; however, EFS data showed an early positive trend favouring Enhertu followed by THP compared to standard of care. The trial will continue to follow EFS

Cision
May 7th, 2025
Enhertu Improved Pcr In Early-Stage Breast Cancer

Enhertu improved pCR in early-stage breast cancer

Bethesda Magazine
May 6th, 2025
AstraZeneca opens cell therapy manufacturing site in Rockville

AstraZeneca announced in February 2024 that it was investing in the Rockville manufacturing facility.