Senior Stat Programmer(dm-sas)

Updated Yesterday Location Pune MH India Job ID 25104427 Description Senior Stat Programmer DM-SAS Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment youa ll collaborate with passionate problem solvers innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives Discover what our 29 000 employees across 110 countries already know WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program We are committed to our Total Self culture a 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 the company we all want to work for and our customers want to work with Why Because when we bring together diversity of thoughts backgrounds cultures and perspectives a wea re able to create a place where everyone feels like they belong Job Responsibilities Uses SAS or other software to develop custom programming code to generate summary tables data listings graphs and derived datasets as specified in the statistical analysis plan and programming specifications Works to ensure that outputs meet quality standards and project requirements Performs validation programming and works with other programmers biostatisticians and other project team members to resolve discrepancies or any findings Keeps project team members informed of programming progress and issues requiring their attention Follow applicable SOPs WIs and relevant regulatory guidelines e g ICH Maintains well organized complete and up-to-date project documentation testing and verification quality control documents and programs ensuring inspection readiness Manages scheduling and time constraints across multiple projects at a time sets goals based on priorities from management and adapts to timeline or priority 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 basis for efficient programming and accurately defines all 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 distributed Follows action items through to completion and maintains order and focus of meetings working toward consensus Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business Accountable for on-time delivery across concurrent programming deliverables Negotiates programming timelines and provides risk mitigation plans for projects or programs as needed Proactively informs management of the status of deliverables and significant project or program issues including planned resolutions Acts as the lead statistical programmer Directs the programming activities of other programming personnel and monitors progress on programming deliverables Reviews project documentation such as Statistical Analysis Plan mock shells programming specifications annotated CRFs and SAS database design Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities Participates in sponsor meetings kickoff 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 clinical drug development industry standards and electronic submission requirements serves as a technical expert resource to other department members for complex programming questions Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures SOPs guidelines policies and or procedures Contributes technical expertise to the development of programming tools and macros for standardization and efficiency When 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 When 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 well as any regulatory required documents i e DEFINE XML When serving as a subject matter expert for CDISC and other industry and regulatory requirements actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards Transfers deliverables Performs other work-related duties as assigned Minimal travel may be required Qualifications Undergraduate degree preferably in a scientific or statistical discipline in lieu of degree Require 5 years of Clinical SAS programming experience strong hands on experience in Base SAS Advance SAS SQL Must have experience of SAS DM listing edit check SAS SQL clinical programming background with Edit checks report reconciliation cleaning the data Must have experience of visualization Good to have experience if SDTM mapping Excellent written and verbal communication skills Ability to read write speak and understand English Get to know Syneos Health Over the past 5 years we have worked with 94 of all 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 youa ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health Additional Information Tasks duties and responsibilities as listed in this job description are not exhaustive The 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 The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above Further nothing 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 comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job Summary Roles within the Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing organizing creating statistical tables listings and graphs and interpreting complex data sets utilizing codes and programs This includes developing codes that create analysis datasets tables and figures evaluating programming processes and suggesting revisions geared toward increasing productivity Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty but may manage two or fewer employees May direct the work of lower level professionals or manage processes and programs The majority of time is spent contributing to the design implementation or delivery of processes programs and policies using knowledge and skills typically acquired through advanced education Leading expert individual contributor who is viewed as a valuable resource by peers Works to achieve organizational functional and or business targets with measurable impact on department results Manages or contributes to projects programs or processes that span multiple related areas Comprehensive knowledge and skills in a professional discipline understanding the impact of work on related areas Share this job