Talent.com
This job offer is not available in your country.
Principal Statistical Programmer

Principal Statistical Programmer

Statistics & Data Corporation (SDC)Hyderabad, TS, IN
30+ days ago
Job type
  • Quick Apply
Job description

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device / diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating / validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations / transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.

Primary Responsibilities

  • Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity
  • Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams
  • Review the Statistical Analysis Plan in preparation for programming the planned analyses
  • Lead design / development of SAS macros and other utilities to expedite SAS programming activities
  • Organize and conduct internal training sessions and author papers for conferences
  • Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and / or approved client request
  • Participate in statistical program validation and quality control activities
  • Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets
  • Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
  • Develop define.xml, study data reviewers guide and analysis datasets reviewers guide
  • Identify study priorities and communicate effectively with project team and management
  • Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours
  • Manage statistical programming timelines, budgets, and client expectations
  • Actively participate in study team meetings
  • Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
  • Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management
  • Program data cleaning checks, as necessary, to assist Data Management’s data cleaning activities
  • Participate in installation / validation of statistical software packages throughout the software development lifecycle
  • Develop and maintain the infrastructure for project files of SAS datasets and SAS code
  • Mentor junior level statistical programmers by developing training plans and providing oversight of their work Ensure all programming activities and processes performed are conducted according to SDC’s standard procedures and / or sponsor requirements
  • Adhere to all aspects of the SDC’s quality system
  • Comply with SDC’s data integrity & business ethics requirements
  • Perform other related duties incidental to the work described herein
  • Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

Required Skills

  • Strong analytical skills, with the ability to process scientific and medical data.
  • Very strong SAS programming skills required, with proficiency in SAS / Base, SAS / Stat, SAS Macros and SAS / Graph
  • Strong problem-solving skills
  • Able to work independently
  • Excellent knowledge of statistical programming
  • Proficient in manipulating and analyzing SAS data
  • Ability to identify data issues, present problems, and implement solutions quickly
  • Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
  • Good organizational and time management skills, with the ability to multi-task
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA / CFR, ICH / GCP). Expert knowledge of CDISC SDTM and ADaM data models
  • Very strong interpersonal communication, presentation, and leadership skills
  • SAS Base, Advance and Clinical Trials Certification is preferred
  • Education or Equivalent Experience

    Bachelor’s degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and / or experience.

    Benefits

    Why SDC

    SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device / diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work / life balance, we are able to attract some of the most talented people in the industry.

  • We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
  • We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
  • We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
  • We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
  • With a proven track record, SDC has been successfully executing client clinical programs since 2005.
  • Take a look at how you can join our team!

    LI-Hybrid

    Create a job alert for this search

    Statistical Programmer • Hyderabad, TS, IN

    Related jobs
    Senior Statistical Programmer

    Senior Statistical Programmer

    IQVIA IndiaHyderabad, Telangana, India
    At a team / site / staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of in...Show moreLast updated: 12 days ago
    Statistical Programmer

    Statistical Programmer

    ProPharma GroupHyderabad
    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes ...Show moreLast updated: 30+ days ago
    • Promoted
    Nesting Programmer (CAM Programmer)

    Nesting Programmer (CAM Programmer)

    Smart WorkingHyderabad, IN
    We’re hiring a Nesting Programmer for Sheet Metal & Buyer for a UK-based Manufacturing and Engineering firm that is providing full-service design-to-manufacture solutions across the UK for industri...Show moreLast updated: 1 day ago
    • Promoted
    SAS Programmer

    SAS Programmer

    VY SYSTEMS PRIVATE LIMITEDHyderabad
    Job Title : SAS Programmer About the Role : As a SAS Programmer, you will play a key role in preparing, processing, and an...Show moreLast updated: 25 days ago
    Manager, Statistical Programming

    Manager, Statistical Programming

    Bristol Myers SquibbINDIA
    Those arent words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optimi...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Principal Statistical Programmer

    Senior Principal Statistical Programmer

    Merck GroupHyderabad
    Your role : As a Senior Principal Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing...Show moreLast updated: 30+ days ago
    Senior Statistical Programmer

    Senior Statistical Programmer

    SanofiHyderabad
    Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC...Show moreLast updated: 30+ days ago
    ERP Principal Programmer Hyderabad, India

    ERP Principal Programmer Hyderabad, India

    TTECHyderabad, India
    We are seeking a technical, process & detail-oriented Senior Consultant to focus on the continued build of Enterprise Risk Management and Audit platform, partnering with multiple teams to execute t...Show moreLast updated: 17 days ago
    • Promoted
    Statistical Programmer

    Statistical Programmer

    Trigent Software - Professional ServicesHyderabad, IN
    Statistical Programmer – SDTM (End-to-End).Develop and validate SDTM datasets in compliance with CDISC standards.Interpret mapping specifications and raw data. Study Data Reviewer's Guide (SDRG).Col...Show moreLast updated: 1 day ago
    PLC Programmer

    PLC Programmer

    Planet Ceramica Private LimitedHyderabad, Telangana, India
    Planet Ceramica is a consulting, supply, project management, and construction company specializing in the glass industry. We offer turnkey project management services with single-point responsibilit...Show moreLast updated: 12 days ago
    Principal Statistical Programmer

    Principal Statistical Programmer

    CytelIndia
    At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talen...Show moreLast updated: 30+ days ago
    Assoc Principal Statistical Programmer / Sr Stat Programmer

    Assoc Principal Statistical Programmer / Sr Stat Programmer

    IQVIAHyderabad, Telangana, India
    Must have expertise of SAS® Base, and good knowledge of SAS® graph and SAS® Macros.Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.Mus...Show moreLast updated: 8 days ago
    • Promoted
    Go Programmer

    Go Programmer

    KAMKON IT SOLUTIONS PVT LTDHyderabad, IN
    We are looking for a highly skilled.The ideal candidate will have hands-on experience in building scalable backend services and APIs using Go, along with a solid understanding of cloud platforms, m...Show moreLast updated: 1 day ago
    • Promoted
    Java / Python Programmer

    Java / Python Programmer

    Quest Global Engineering Solutions Private LimitedHyderabad
    Job Description : - Experience developing solutions utilizing in Java and python - Industry experience in manufacturing test platform development&...Show moreLast updated: 23 days ago
    Principal Statistical Programmer

    Principal Statistical Programmer

    ParexelRemote, Hyderabad, India
    Remote
    When our values align, there's no limit to what we can achieve.Ability to fill Statistical Programming Lead role on projects. Input into and negotiate statistical programming timelines.Ensure that t...Show moreLast updated: 30+ days ago
    Senior Statistical Programmer

    Senior Statistical Programmer

    ASTRAZENECAINDIA
    Job Title : Senior Statistical Programmer I.Join our dynamic and diverse environment in the BioPharmaceuticals Business Unit as a Senior Statistical Programmer. This delivery-focused role requires te...Show moreLast updated: 30+ days ago
    • Promoted
    Rave Programmer

    Rave Programmer

    PRI GlobalHyderabad, Telangana, India
    Rave programmer experience with 4+ years of core CF experience.Need to independently work with client team.Experience of handling complex CF activities, Email alert checks where user roles need to ...Show moreLast updated: 25 days ago
    • Promoted
    Rave Programmer

    Rave Programmer

    Netpace Technologies Solutions Pvt. LtdHyderabad
    We are looking for Rave programmers with below skills : Experience : 4-6 years (Rave with minimal or basic familiarity with CF but CF should be there in the resume) &...Show moreLast updated: 7 days ago