Senior Statistical Programmer (sdtm)- Hybrid (hyderabad /gurugram)

Updated Yesterday Location Gurgaon HR India Job ID 25103411 Description Senior Statistical Programmer SDTM - Hybrid Hyderabad Gurugram 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 5 years of relevant clinical SAS Statistical programming experience Prefer to have SME level review capabilities at an experienced Senior level profile SDTM role a Strong programming exposure of safety efficacy domain including hands-on experience of tasks like CRF annotations SDTM specifications writing data management including Vendor data handling e-submission tasks viz DEFINE SDRG Proven track record of leading multiple clinical trials and demonstrating proactive project management skills lead experience of min 1 year Excellent understanding of the clinical domain CDISC standards and experience across various supported therapeutic areas Strong communication skills problem-solving abilities and ability to work collaboratively in cross-functional teams in a dynamic environment FSO experience is preferred Clinical Phases Phase-I II III IV except for dedicated Phase I exposure TA Oncology Neurology Or any TA 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 and 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 Prepares in advance for internal meetings contributes ideas and demonstrates respect for opinions of others 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 Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management and completes project programming activities within timeframe allotted 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 program Up