Lead Statistical Programmer

1 week ago

Vijayawada, India K3-Innovations, Inc. Full time

Responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. Works closely with Biostatisticians and Data Managers to support creating SAS programs for independently validating tables, listings, and figures produced by programming vendors, for ad-hoc analyses, and to assist with data cleaning and query generation. Independently produces selected SDTMs/ADaM/TFLs for analysis preparation and for validation. Serves as a contact for programming activities being performed at assigned CROs.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Provides SAS programming support to all clinical studies.
  • Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
  • Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
  • Provides primary programming and QC support for any internally produced outputs.
  • Reviews and approves SAS programming instructions and CDISC/ADaM specifications.
  • Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
  • Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
  • Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
  • Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders.
  • Assists with ensuring consistency across programming methods in similar studies within a program.


JOB QUALIFICATIONS:

Education, Certifications, Experience:

  • Bachelor’s Degree or Master’s degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry
  • Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development


Knowledge, Skills and Abilities:

  • Knowledge of pharmaceutical and regulatory requirements, procedures, and policies.
  • Experience with BLA or NDA/sNDA submissions is required.
  • Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
  • In depth knowledge of CDISC and ADaM data set structures and requirements
  • Proficiency with SAS programming skills to including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL) Knowledge of all aspects of clinical drug development (Phase 1-4)
  • Experience working with a CRO partner.
  • Excellent computer skills; strong verbal and written communication skills
  • Ability to work well in a team environment as a contributor.
  • Open, engaging, and transparent work style
  • Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment

  • Data Scientist

    1 month ago

    Vijayawada, India Intuition IT – Intuitive Technology Recruitment Full time

    Role: Data ScientistContract: Freelance/B2BDuration: 6 months plus possible extensionLocation: 100% remote from IndiaJD – • Data Science Lead with statistical modelling experience with hands-on experience using Python and Pyspark (Mandatory)• Experience in developing Churn Model, KPI Forecasting Models, Predictive Modelling (few examples)• Good...

  • Team Lead

    3 weeks ago

    vijayawada, India Firstsource Full time

    A RP Sanjiv Goenka Group company. Firstsource is a leading provider of customized Business Process Management (BPM) services. We are trusted custodians and long-term partners to 100+ leading brands with a presence in the US, UK, India, and Philippines. Our ‘rightshore’ delivery model offers solutions covering complete customer lifecycle across...

  • Leading AI Developer with Advanced Python Expertise

    1 week ago

    Vijayawada, Andhra Pradesh, India iitjobs, Inc. Full time

    About the RoleGreetings, we are seeking a highly skilled Senior Machine Learning Engineer to join our team. The ideal candidate will have extensive experience in developing, deploying, and operationalizing projects in statistical machine learning, natural language processing, and more.Key ResponsibilitiesDevelop and deploy machine learning models using...

  • Senior SAP Business Transformation Manager

    2 weeks ago

    Vijayawada, Andhra Pradesh, India Promaynov Advisory Services Pvt. Ltd Full time

    Job Description:A key role in Promaynov Advisory Services Pvt. Ltd, this Senior SAP Business Transformation Manager will be responsible for leading the cutover activities to ensure a successful implementation of the Business Operations Transformation (BOT) Project.Key Responsibilities:Cutover Approach: Develop a comprehensive approach for the cutover...

  • Information Technology Project Manager

    4 days ago

    Vijayawada, India Areteans Full time

    Job Title: Project Manager Job Type: Full TimeJob Location: Hyderabad/Bangalore/Chennai/Pune/Gurgaon/Bhubaneswar/KolkataKey Responsibilities:Delivery of projects as per contract and aligning to the company strategy, planning and implementation rules and regulationsClosely working with Clients and Business leaders and lead a healthy Project marginTraining and...

  • Field Sales Representative

    6 months ago

    Vijayawada, India TechWebLabs by Anxion webtech PVT LTD Full time

    **Job description** ⦁ ‘Get the Sale’ by using different customer sales techniques ⦁ Forecast sales, generate ‘out of the box’ sale methodologies and evaluate their effectiveness ⦁ Attract new clients by new strategies and sales processes ⦁ Evaluate client’s needs, skills and build a productive long lasting relationship ⦁ Meet...

  • Department Head, Science and Technology

    1 month ago

    Vijayawada, Andhra Pradesh, India Nalanda Academy of Science and TechnicalEducation Full time

    **Key Responsibilities**The Department Head, Science and Technology will oversee the science department at Nalanda Academy of Science and Technical Education. This includes managing the departmental budget, recruiting and developing faculty members, and ensuring compliance with regulations and accreditation standards.**Leadership and Management**The...

  • Campus Ambassador

    6 months ago

    Vijayawada, India The Trail company Full time

    **Job Title**: Campus Ambassador **About the Company**: The Trial Co. is the division of Cabeats Tech Pvt Ltd. Over the past four years. Cabeats has successfully provided four million trails for P&G (Procter & Gamble India) in states like Maharashtra, Uttar Pradesh, Delhi, Madhya Pradesh, Chennai. The Trial Co. is dedicated to offering customers the chance...

  • Full Stack Engineer

    2 weeks ago

    Vijayawada, India Synechron Full time

    Synechron is a leading digital consulting firm with 14,500+ collaborative employees across 44 global offices across 19 countries. From our solid financial services industry foundation, we have become a prominent global digital consulting firm for large financial services and technology firms. With a key focus on trust, and in partnership with our clients,...

  • Analytics Manager

    3 months ago

    Vijayawada, India noon Full time

    About noonnoon, the region's leading consumer commerce platform. On December 12th, 2017, noon launched its consumer platform in Saudi Arabia and the UAE, expanding to Egypt in February 2019. The noon ecosystem of services now includes marketplaces for food delivery, quick-commerce, fintech, and fashion. noon is a work in progress; we’re six years in, but...

  • Senior Machine Learning and AI Scientist

    3 weeks ago

    Vijayawada, India MEDGENOME Full time

    Find your next role with MedGenome Labs Ltd. We are the market leader in clinical genomic space in India and offers a comprehensive rangeof diagnostic servicesto doctors and researchers. We operate the largest CAP accredited Next Generation Sequencing (NGS) lab in Southeast Asia housing cutting-edge genome sequencing platforms. MedGenome is the founding...

  • Product Field Sales Executive

    3 months ago

    Vijayawada, India Rentokil Initial Full time

    Rentokil PCI is the leading pest control service provider in India. A Rentokil Initial brand, Rentokil PCI was formed in 2017 through a joint venture (JV) between Pest Control India, the number one pest control company in India, and Rentokil, the world’s leading pest control brand. Rentokil PCI aims to set new standards for customer service with operations...

  • Pmu

    6 months ago

    Vijayawada, Andhra Pradesh, India Indian School of Business Full time

    **Job Title**: PMU (Project Management Unit) Lead **Function**: Bharti Institute of Public Policy (BIPP) **Reports to position**: Executive Director **Location**: Vijayawada **Reportees to Position**: Operations Specialist(s), Field Interns, Research Assistant (indicative list) **Band**: FT **Rural prosperity through forest-based livelihoods -...

  • State Program Assistant

    2 weeks ago

    Vijayawada, Andhra Pradesh, India PATH Full time

    PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges. Over the last few years,...