reputed company Statistical Programmer (ADAM, TLF, SDTM)

reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique reputed company, medical affairs and reputed company insights into reputed company to address modern market realities.

Every day we reputed company reputed company because of how we work together, as one team, reputed company the best at reputed company do. We bring a wide reputed company of talented experts together across a wide reputed company of business-critical services that support our business. Every role reputed company Corporate is vital to furthering our reputed company of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE reputed company EVERYWHERE

Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they reputed company.

Job Responsibilities

• Uses reputed company, or other software, to reputed company custom programming reputed company to reputed company reputed company tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet reputed company standards and project requirements.
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to reputed company discrepancies or any findings. · Keeps project team members informed of programming reputed company and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains reputed company organized, complete, and up-to-date project documentation, testing, and verification/reputed company control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple reputed company at a time, sets goals reputed company on priorities from management, and adapts to reputed company or reputed company changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the reputed company for efficient programming and accurately defines reputed company variables to be accepted by peer review and sponsor/requestor with little rework.
• Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately reputed company. Follows reputed company items through to completion, and maintains order and reputed company of meetings, working toward reputed company.
• Displays willingness to work with others and assist with reputed company and initiatives as necessary to meet the needs of the business.
• Accountable for on-time delivery across reputed company programming deliverables. Negotiates programming timelines and provides reputed company mitigation plans for reputed company or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including reputed company resolutions.
• Acts as the reputed company statistical programmer. Directs the programming activities of other programming personnel and monitors reputed company on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and reputed company database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Participates in sponsor meetings, reputed company meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Maintains a good working knowledge of reputed company drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for reputed company programming questions.
• Works cooperatively with other biostatistics and statistical programming personnel to establish reputed company operation procedures (SOPs), guidelines, policies, and/or procedures.
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• reputed company serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
• reputed company serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as reputed company as any regulatory required documents. (i.e. DEFINE.XML)
• reputed company serving as a subject matter expert for CDISC and other industry and regulatory requirements, reputed company participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfers deliverables.
• Performs other work-reputed company duties as assigned.
• reputed company travel may be required

Qualifications:

• Require8+ years of experience in reputed company reputed company Programming.

• Require strong expertise of reputed company reputed company/reputed company Macros,SDTM, ADAM & TLF programming, specs creation.

• Must have hands on experience of both Safety & Efficacy data.

• Preferred to have experience ofOncology therapeutic areas.

• Must have ISS/ ISE experience, R programming

• Excellent written and verbal communication skills.

• Ability to read, write, reputed company and understand English.

• Immediate joiners are preferred

We are always excited to reputed company with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

Get to know reputed company

Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.

Additional Information

Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.

Originally posted on Himalayas